Trial Outcomes & Findings for The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky (NCT NCT03725332)

Last Updated: 2025-05-01

Results Overview

Medical records will be reviewed post-partum for treatment for NAS. Diagnosis of NAS will be made within 10 days of birth and treatment started based on standard of care. Data will be presented as the percent of infants born requiring therapy in each group.

Recruitment status

COMPLETED

Study phase

Target enrollment

269 participants

Primary outcome timeframe

up to 10 days postpartum

Results posted on

2025-05-01

Participant Flow

On 8/30/2019 study design was changed to a non-inferiority and recruitment to 533. Unable to meet 533 within the time frame and budget allotted, 4 secondary outcomes were powered: Urine drug screen at delivery, number of interventions, prenatal visits and MAT visits attended. On 8/2022, recruitment target changed to 256-80 participants in telemedicine, and 176 in group. Final enrollment was 269. Enrollment occurred between 3/13/19-10/16/23 at 13 sites.

Randomization to Group or Telemedicine was at the site level. All enrollments were predetermined by the site which the women enrolled. There was no period between enrollment and assignment. Enrollment and assignment occurred simultaneously. Wash out- periods and Run-in periods are not applicable to this study

Unit of analysis: study sites

Participant milestones

Participant milestones
Measure	Telemedicine Education This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff.	Group Care Education This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff.
Overall Study STARTED	82 6	187 7
Overall Study At Delivery	79 6	175 7
Overall Study At 4 Weeks Postpartum	33 6	70 7
Overall Study At 3 Months Postpartum	37 6	58 7
Overall Study COMPLETED	33 6	49 7
Overall Study NOT COMPLETED	49 0	138 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Telemedicine Education This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff.	Group Care Education This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff.
Overall Study Adverse Event	5	10
Overall Study Death	1	3
Overall Study Lost to Follow-up	43	122
Overall Study Withdrawal by Subject	0	1
Overall Study Duplicate enrollment	0	1
Overall Study Did not consent	0	1

Baseline Characteristics

The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telemedicine Education n=82 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=184 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Total n=266 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	82 Participants n=5 Participants	184 Participants n=7 Participants	266 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.4 years STANDARD_DEVIATION 4.8 • n=5 Participants	30.1 years STANDARD_DEVIATION 5.4 • n=7 Participants	30.2 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	184 Participants n=7 Participants	266 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	78 Participants n=5 Participants	182 Participants n=7 Participants	260 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	78 Participants n=5 Participants	181 Participants n=7 Participants	259 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants	184 participants n=7 Participants	266 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 10 days postpartum

Population: Number of participants (infants) available for data analysis per protocol

Outcome measures

Outcome measures
Measure	Telemedicine Education n=80 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=177 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Percent of Infants Diagnosed With Neonatal Abstinence Syndrome (NAS) Requiring Medication Treatment	24.1 % infants requiring medication for NAS	33.3 % infants requiring medication for NAS

SECONDARY outcome

Timeframe: Up to 10 days post-partum

Population: Participants available for data analysis per protocol

Maternal urine drug screen (UDS) will be collected at the time of hospital admission for delivery for each participant. A urine drug screen is considered inappropriate when the presence of an illicit drug that is not prescribed for the participant is detected or the prescribed medication for opioid use disorder is not detected. The actual number of inappropriate maternal drug screens will be calculated. Results will be compared between Arms: Telemedicine and Group

Outcome measures

Outcome measures
Measure	Telemedicine Education n=63 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=164 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Number of Inappropriate Maternal Drug Screens at Delivery	12 # of inappropriate maternal drug screens	29 # of inappropriate maternal drug screens

SECONDARY outcome

Timeframe: Up to delivery, an average of 19 weeks

Population: Number of participants available for data analysis per protocol.

Engagement with PATHHome is measured by the number of counseling/education sessions (groups or telemedicine) attended by each participant. Results will be compared between Arms and expressed as percent of interventions attended by participants.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=79 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=175 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Prenatal Engagement With Percent of Program Education Sessions Attended No intervention attended	12 Participants	36 Participants
Prenatal Engagement With Percent of Program Education Sessions Attended 5-50% interventions attended	26 Participants	62 Participants
Prenatal Engagement With Percent of Program Education Sessions Attended 51-100% interventions attended	41 Participants	77 Participants

SECONDARY outcome

Timeframe: Up to delivery, an average of 19 weeks

Population: Number of participants available for data analysis per protocol

Engagement with MAT provider is measured by the average number of visits attended by each participant with their MAT provider.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=82 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=184 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Prenatal Engagement With MAT Provider	12.0 Visits Standard Error 1.70	8.40 Visits Standard Error 0.65

SECONDARY outcome

Timeframe: Up to delivery, an average of 19 weeks

Population: Number of participants available for data analysis per protocol.

Engagement with Prenatal Care is considered by gestational age of entry. The number of prenatal visits is expressed as a percentage of prenatal visits attended with a denominator of prenatal visits scheduled. The data is provided by patient report and confirmed by medical record review when possible. Results will be compared between Arms. Categories reported are no prenatal visits, 5-50%, 51-100%.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=79 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=175 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Prenatal Engagement in Prenatal Care 51-100% prenatal care visits	59 Participants	129 Participants
Prenatal Engagement in Prenatal Care No prenatal care visits	4 Participants	11 Participants
Prenatal Engagement in Prenatal Care 5-50% prenatal care visits	16 Participants	35 Participants

SECONDARY outcome

Timeframe: Up to 60 weeks

Population: Number of participants available for data analysis per protocol

Participants will complete the Fagerstrom Test for Cigarette Dependence 4 times during the course of the study: Intake, 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). This is a 7-question survey with each question scored on a scale of zero to 3 and totaled. Scores greater than 8 are considered high dependency, scores of 5-7 are considered moderately dependent, scores of 3-4 are low to moderate dependence and scores of 1-2 are low dependence. Data will be presented as the number of participants with cigarette dependency over time compared between groups.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=82 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=184 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Participants With Cigarette Dependency Over Time 28-32weeks · 8-10: High dependency	8 Participants	4 Participants
Participants With Cigarette Dependency Over Time Intake · 0: None; Former or never smoker	14 Participants	42 Participants
Participants With Cigarette Dependency Over Time Intake · 1-2: Low dependency	7 Participants	20 Participants
Participants With Cigarette Dependency Over Time Intake · 3-4: low- moderate dependency	15 Participants	28 Participants
Participants With Cigarette Dependency Over Time Intake · 5-7: Moderate dependency	27 Participants	64 Participants
Participants With Cigarette Dependency Over Time Intake · 8-10: High dependency	12 Participants	17 Participants
Participants With Cigarette Dependency Over Time 28-32weeks · 0: None; Former or never smoker	10 Participants	23 Participants
Participants With Cigarette Dependency Over Time 28-32weeks · 1-2: Low dependency	4 Participants	10 Participants
Participants With Cigarette Dependency Over Time 28-32weeks · 3-4: low- moderate dependency	8 Participants	23 Participants
Participants With Cigarette Dependency Over Time 28-32weeks · 5-7: Moderate dependency	12 Participants	29 Participants
Participants With Cigarette Dependency Over Time 3 months postpartum · 0: None; Former or never smoker	5 Participants	16 Participants
Participants With Cigarette Dependency Over Time 3 months postpartum · 1-2: Low dependency	2 Participants	9 Participants
Participants With Cigarette Dependency Over Time 3 months postpartum · 3-4: low- moderate dependency	4 Participants	7 Participants
Participants With Cigarette Dependency Over Time 3 months postpartum · 5-7: Moderate dependency	12 Participants	13 Participants
Participants With Cigarette Dependency Over Time 3 months postpartum · 8-10: High dependency	8 Participants	4 Participants
Participants With Cigarette Dependency Over Time 6 months postpartum · 0: None; Former or never smoker	4 Participants	17 Participants
Participants With Cigarette Dependency Over Time 6 months postpartum · 1-2: Low dependency	3 Participants	6 Participants
Participants With Cigarette Dependency Over Time 6 months postpartum · 3-4: low- moderate dependency	6 Participants	7 Participants
Participants With Cigarette Dependency Over Time 6 months postpartum · 5-7: Moderate dependency	8 Participants	7 Participants
Participants With Cigarette Dependency Over Time 6 months postpartum · 8-10: High dependency	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 60 weeks

Population: Number of participants available for data analysis per protocol

Participants will complete the Generalized Anxiety Disorder survey at their intake visit, at 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). The survey consists of 7 questions probing the participants burden of anxiety. Each question is scored from 0 to 3, with 3 representing the most severe state. A total score of 1-4 indicates minimal anxiety, 5-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. Data will be presented as the number of participants with anxiety over time compared between groups.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=82 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=184 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Participants With Maternal Anxiety Over Time 3 months postpartum · 5-14 Moderate anxiety	15 Participants	20 Participants
Participants With Maternal Anxiety Over Time 3 months postpartum · 15-21 Severe anxiety	0 Participants	5 Participants
Participants With Maternal Anxiety Over Time 6 months postpartum · '0': No anxiety	6 Participants	10 Participants
Participants With Maternal Anxiety Over Time 6 months postpartum · 1-4: Minimal anxiety	7 Participants	10 Participants
Participants With Maternal Anxiety Over Time 6 months postpartum · 5-14 Moderate anxiety	11 Participants	18 Participants
Participants With Maternal Anxiety Over Time 6 months postpartum · 15-21 Severe anxiety	2 Participants	1 Participants
Participants With Maternal Anxiety Over Time Intake · '0': No anxiety	7 Participants	23 Participants
Participants With Maternal Anxiety Over Time Intake · 1-4: Minimal anxiety	16 Participants	50 Participants
Participants With Maternal Anxiety Over Time Intake · 5-14 Moderate anxiety	43 Participants	78 Participants
Participants With Maternal Anxiety Over Time Intake · 15-21 Severe anxiety	11 Participants	20 Participants
Participants With Maternal Anxiety Over Time 28-32 weeks · '0': No anxiety	5 Participants	23 Participants
Participants With Maternal Anxiety Over Time 28-32 weeks · 1-4: Minimal anxiety	11 Participants	27 Participants
Participants With Maternal Anxiety Over Time 28-32 weeks · 5-14 Moderate anxiety	26 Participants	34 Participants
Participants With Maternal Anxiety Over Time 28-32 weeks · 15-21 Severe anxiety	5 Participants	7 Participants
Participants With Maternal Anxiety Over Time 3 months postpartum · '0': No anxiety	6 Participants	11 Participants
Participants With Maternal Anxiety Over Time 3 months postpartum · 1-4: Minimal anxiety	10 Participants	13 Participants

SECONDARY outcome

Timeframe: Up to 60 weeks

Population: Number of participants available for data analysis per protocol

Participants will complete the Edinburgh Depression Scale at 4 times during the study: Intake visit, at 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). The survey consists of 10 questions. Each question is scored between 0-3. An answer of 3 represents a more severe state. A total score of 1-8 falls within a normal range, a score is 9-10 is at risk for depression and a score of 11 or more indicates depression. In general, the higher the score, the more severe the depression. Data will be presented as the number of participants with depression over time compared between groups.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=82 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=184 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Participants With Maternal Depression Over Time Intake · 1-8: Normal	24 Participants	60 Participants
Participants With Maternal Depression Over Time Intake · 9-10: At risk for depression	8 Participants	19 Participants
Participants With Maternal Depression Over Time Intake · 11-29: Depression	46 Participants	88 Participants
Participants With Maternal Depression Over Time 28-32 weeks · 1-8: Normal	21 Participants	38 Participants
Participants With Maternal Depression Over Time 28-32 weeks · 9-10: At risk for depression	5 Participants	10 Participants
Participants With Maternal Depression Over Time 28-32 weeks · 11-29: Depression	20 Participants	37 Participants
Participants With Maternal Depression Over Time 3 months postpartum · 1-8: Normal	20 Participants	19 Participants
Participants With Maternal Depression Over Time 3 months postpartum · 9-10: At risk for depression	2 Participants	10 Participants
Participants With Maternal Depression Over Time 3 months postpartum · 11-29: Depression	9 Participants	16 Participants
Participants With Maternal Depression Over Time 6 months postpartum · 1-8: Normal	13 Participants	15 Participants
Participants With Maternal Depression Over Time 6 months postpartum · 9-10: At risk for depression	1 Participants	7 Participants
Participants With Maternal Depression Over Time 6 months postpartum · 11-29: Depression	9 Participants	13 Participants

SECONDARY outcome

Timeframe: 28-32 weeks gestation

Population: Number of participants available for data analysis per protocol

WHO-Quality of Life Survey (WHOQoL) will be administered to patients at 28-32 weeks gestation. WHOQoL is a 26 question self administered survey. Each question falls within 1 of 4 "domains": physical health, psychological health, social relationships, environment. For purposes of reporting, we are using the first question, "How would you rate your quality of life?" on a scale of 1-5, with 1 being very poor quality, 2 poor quality, 3 neither poor nor good, 4 good quality, 5 very good quality.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=46 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=91 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Participant Quality of Life Very Good quality of life	18 Participants	29 Participants
Participant Quality of Life Good quality of life	26 Participants	55 Participants
Participant Quality of Life Neither poor nor good quality of life	2 Participants	6 Participants
Participant Quality of Life Poor quality of life	0 Participants	1 Participants
Participant Quality of Life Very poor quality of life	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Intake visit (between 6-32 weeks gestation)

Population: Number of participants available for data analysis per protocol

Participants will complete a Diagnostic and Statistical Manual of Mental Disorders-5-TR, Addiction Severity Scale to assess their opioid dependency at the intake visit (between 6-32 weeks). The survey asks 11 questions. Each question asks about symptoms related to opioid use disorder and are answered in a yes/no format. A mild substance use disorder is diagnosed with 2-3 symptoms, moderate with 4-5 symptoms, and severe is 6 or more symptoms. Data will be presented as the number of participants in each category.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=82 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=184 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Severity of Opioid Use Disorder 0-1: None/Minimal	41 Participants	65 Participants
Severity of Opioid Use Disorder 2-3: Mild	8 Participants	25 Participants
Severity of Opioid Use Disorder 4-5: Moderate	7 Participants	15 Participants
Severity of Opioid Use Disorder 6-11: Severe	22 Participants	63 Participants

SECONDARY outcome

Timeframe: up to 60 weeks

Population: Number of participants available for data analysis per protocol

Hospitalizations for opioid related issues were determined by two main methods. Participants were assessed for hospitalization at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, hospitalizations were determined and confirmed through medical record review when possible. Data will be presented as number of hospitalizations in each arm.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=82 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=184 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Incidence of Hospitalization for Opioid Related Issues During the Study Period	2 Numbe of hospitalizations	4 Numbe of hospitalizations

SECONDARY outcome

Timeframe: Up to five minutes

Population: Telemedicine arm had one set of twins; Group arm had two sets of twins. Number of participants available for data analysis per protocol

Infant physical condition at birth will be assessed using the Apgar score at 1 minute and 5 minutes after birth. The Apgar score consists of 5 criteria: Appearance (skin color), pulse, grimace (reflex irritability), activity (muscle tone), respiration. Each criteria is scored 0-2. Scores are summed to evaluate a newborns health. A score of 8-10 is considered normal. A score less than 8 requires medical support. The lower the score, the more severely affected the newborn. Data will be presented as the change in Apgar score over time compared between groups.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=75 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=169 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Change in Physical Condition of Infant Post-delivery by Apgar Score 1 minute after birth	7.89 score on a scale Standard Error 0.14	7.94 score on a scale Standard Error 0.11
Change in Physical Condition of Infant Post-delivery by Apgar Score 5 minutes after birth	8.61 score on a scale Standard Error 0.10	8.76 score on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: birth-six months

Population: Number of infants available for data analysis per protocol

Pediatric emergency room visits will be determined by both in person reporting during a postpartum intervention and by medical record review. Time span starts at discharge from the hospital (after birth) to 6 months postpartum. Data will be presented as the total number of pediarric ER visits compared between groups

Outcome measures

Outcome measures
Measure	Telemedicine Education n=75 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=171 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Incidence of Pediatric Emergency Room (ER) Visits	10 Number of infants	11 Number of infants

SECONDARY outcome

Timeframe: Infant 3 months and 6 months of age

Population: Number of infants available for data analysis per protocol

Adherence to a vaccine schedule will be determined by both in person reporting during a postpartum intervention and by medical record review when possible. Participants will be asked at their 3 and 6-month postpartum visit; "Is your infant up to date on vaccines?". Data will be presented as the total number of infants compliant on their vaccines and compared between groups.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=75 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=171 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Adherence to a Vaccine Schedule Infant 3 months of age	27 Number of infants	45 Number of infants
Adherence to a Vaccine Schedule Infant 6 months of age	22 Number of infants	39 Number of infants

SECONDARY outcome

Timeframe: Infant 3 month and 6 months of life

Population: Number of infants available for data analysis per protocol

Engagement with pediatric care will be determined by both in person reporting during a postpartum intervention and by medical record review when possible. Participants will be asked at their 3 and 6-month postpartum visit; "Does your baby regularly see a pediatrician?". Data will be presented as the total number of infants engaged in pediatric care and compared between groups.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=75 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=171 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Engagement With Pediatric Care Infant 3 months of age	30 Number of infants adhering	49 Number of infants adhering
Engagement With Pediatric Care Infant 6 months of age	26 Number of infants adhering	42 Number of infants adhering

SECONDARY outcome

Timeframe: Infant at 3 months of age

Population: Number of participants available for data analysis per protocol

The Ages \& Stages Questionnaires®, Third Edition (ASQ®-3) was completed by the participant at the 3-month postpartum intervention. The survey collects infant milestones in five domains: communication, gross motor, fine motor, problem-solving, and personal/social. The developmental instrument is 38 items and scored by the research staff. For purposes of reporting, we are utilizing the gross motor domain subsection score only. This domain includes 6 questions. Scores are calculated at 0, 5, or 10 per question. The highest score is 60- the lowest score would be 0. The higher the score the better. For a score greater than 41 development is considered to be on schedule. If the score falls between 38-41- targeted learning activities and monitoring is recommended. If the score falls below 38, concern for lagging infant motor development and further assessment with a professional is recommended. Scores will be presented as the mean +/- standard error compared between group

Outcome measures

Outcome measures
Measure	Telemedicine Education n=75 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=171 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Infant Gross Motor Development	53.10 score on a scale Standard Error 1.52	55.22 score on a scale Standard Error 0.88

SECONDARY outcome

Timeframe: Infant at 6 months of age

Population: Number of infants available for data analysis per protocol

The Ages \& Stages Questionnaires®, Third Edition (ASQ®-3) was completed by the participant at the 6-month postpartum intervention. The survey collects infant milestones in five domains: communication, gross motor, fine motor, problem-solving, and personal/social. The Ages and Stages 6-month survey instrument is 38 items and scored by the research staff. For purposes of reporting, we are utilizing the gross motor domain score only. This domain includes 6 questions, scores are calculated at 0, 5, or 10 per question and a score below 22 is concerning for lagging infant motor development. Scores will be presented as the mean +/- standard error compared between groups.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=75 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=171 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Infant Gross Motor Development	50.40 score on a scale Standard Error 2.71	48.71 score on a scale Standard Error 1.41

SECONDARY outcome

Timeframe: Up to 60 weeks

Population: Number of participants available for data analysis per protocol

Relapse was defined as the use of any illicit substance or misuse of prescribed medications including medication for opioid use disorder. Incidence of relapse was determined by two main methods. Participants were assessed for relapse at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, relapses were determined and confirmed through medical record review, including inappropriate urine drug screens, when possible. Data will be presented in 2 categories: Relapse with opioids and relapse with other substances. The number of relapses is not equal to the number of participants as a single participant may have more than one relapse or polysubstance relapse. Data will be presented as the total number of relapses and compared between groups.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=82 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=184 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Incidence of Relapse Relapse with opioids	10 Number of relapses	29 Number of relapses
Incidence of Relapse Relapse with other substances	37 Number of relapses	188 Number of relapses

SECONDARY outcome

Timeframe: Up to 60 weeks

Population: Number of participants available for data analysis per protocol

The incidence of opioid overdose was determined by two main methods. Participants were assessed for overdose at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, overdoses were determined and confirmed through medical record review when possible. Data will be presented as number of overdoses in each arm.

Outcome measures

Outcome measures
Measure	Telemedicine Education n=82 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=184 Participants This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Incidence of Opioid Overdose	0 Number of opioid overdoses	4 Number of opioid overdoses

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 60 weeks

Participants will be asked about employment status during their intake visit, at 28 weeks gestational age, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). Participants will answer "yes" or "no" regarding their employment status. Data will be presented as the change in employment status between groups.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 38 weeks

Participants will be asked to indicate the total number of people sharing their living space during the intake visit, and 6 months postpartum (combined total time of observation is up to 38 weeks). Data will be presented as the change in dwelling occupancy over time compared between groups.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 months postpartum

Participants will be offered long-acting reversible contraception. Data will be presented as the number of participants per group accepting long term contraception.

Outcome measures

Outcome data not reported

Adverse Events

Telemedicine Education

Serious events: 20 serious events

Other events: 72 other events

Deaths: 1 deaths

Group Care Education

Serious events: 46 serious events

Other events: 166 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Hansen, MD

University of Kentucky

Phone: 859-218-0765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Telemedicine Education n=82 participants at risk This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff. Telemedicine: Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.	Group Care Education n=184 participants at risk This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (\>500 deliveries/year) and 'low volume' (\<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff. Group Care: Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Infections and infestations Respiratory	13.4% 11/82 • Number of events 15 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	4.9% 9/184 • Number of events 10 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Pregnancy, puerperium and perinatal conditions IUGR	15.9% 13/82 • Number of events 13 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	12.5% 23/184 • Number of events 23 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Psychiatric disorders Relapse THC	11.0% 9/82 • Number of events 11 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	16.3% 30/184 • Number of events 36 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Renal and urinary disorders Urinary	7.3% 6/82 • Number of events 11 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	13.0% 24/184 • Number of events 26 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	13.4% 11/82 • Number of events 11 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	5.4% 10/184 • Number of events 10 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Psychiatric disorders MAT misuse	12.2% 10/82 • Number of events 12 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	15.2% 28/184 • Number of events 31 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Psychiatric disorders Relapse opioids	11.0% 9/82 • Number of events 10 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	9.8% 18/184 • Number of events 29 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Psychiatric disorders Relapse amphetamines	7.3% 6/82 • Number of events 9 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	19.6% 36/184 • Number of events 46 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Pregnancy, puerperium and perinatal conditions Preterm labor	8.5% 7/82 • Number of events 9 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	10.3% 19/184 • Number of events 25 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Pregnancy, puerperium and perinatal conditions Fetal distress, non-reactive NST/Elevated Dopplers, non-reassuring BPP	9.8% 8/82 • Number of events 9 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	9.2% 17/184 • Number of events 17 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
General disorders Pain	4.9% 4/82 • Number of events 9 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	5.4% 10/184 • Number of events 12 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Gastrointestinal disorders Dental	9.8% 8/82 • Number of events 9 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	5.4% 10/184 • Number of events 10 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Psychiatric disorders Relapse benzodiazepines	6.1% 5/82 • Number of events 8 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	9.2% 17/184 • Number of events 18 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Pregnancy, puerperium and perinatal conditions Gestational Hypertension	7.3% 6/82 • Number of events 7 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	10.3% 19/184 • Number of events 21 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Psychiatric disorders Relapse gabapentin	6.1% 5/82 • Number of events 6 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	12.0% 22/184 • Number of events 38 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Infections and infestations STI	6.1% 5/82 • Number of events 6 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	6.0% 11/184 • Number of events 19 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Infections and infestations COVID	7.3% 6/82 • Number of events 6 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	8.2% 15/184 • Number of events 15 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Psychiatric disorders Illicit Suboxone Use	4.9% 4/82 • Number of events 4 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	10.9% 20/184 • Number of events 30 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Psychiatric disorders Postpartum Depression	4.9% 4/82 • Number of events 4 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	7.6% 14/184 • Number of events 14 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.
Ear and labyrinth disorders ENT	8.5% 7/82 • Number of events 7 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.	4.9% 9/184 • Number of events 10 • From enrollment (between 6-32 weeks pregnant) until infant is 6 months old. Definition of adverse event and serious adverse event matches the clinicaltrials.gov definitions. Infant adverse events were not part of the research plan. Adverse events only collected on mothers. Three Group Arm participants were not assessed due to administrative errors.