Trial Outcomes & Findings for EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan (NCT NCT04933812)

NCT ID: NCT04933812

Last Updated: 2024-11-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: up to 12 weeks after delivery (approximately 1 year)
• Results posted on: 2024-11-04

Participant Flow

Participant milestones

Measure	Group Social Support Meetings and Facebook Group Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom
Overall Study STARTED	31
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan

Baseline characteristics by cohort

Measure	Group Social Support Meetings and Facebook Group n=29 Participants Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	33.3 years STANDARD_DEVIATION 6.0 • n=93 Participants
Sex: Female, Male Female	29 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	29 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	29 Participants n=93 Participants

PRIMARY outcome

Timeframe: up to 12 weeks after delivery (approximately 1 year)

Outcome measures

Measure

Group Social Support Meetings and Facebook Group n=29 Participants Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom

Number of Eligible Participants Who Are Successfully Recruited and Attend at Least One Group Session

20 Participants

PRIMARY outcome

Timeframe: up to 12 weeks after delivery (approximately 1 year)

As a measure of effectiveness

Outcome measures

Measure

Group Social Support Meetings and Facebook Group n=29 Participants Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom

Number of Sessions Attended by Each Participant

5.7 sessions Standard Deviation 6.9

PRIMARY outcome

Timeframe: up to 12 weeks after delivery (approximately 1 year)

Outcome measures

Measure	Group Social Support Meetings and Facebook Group n=51 Sessions Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom
Implementation as Measured by the Number of Sessions Including Each Topic Individualized Prematurity Prevention Plan	14 Sessions
Implementation as Measured by the Number of Sessions Including Each Topic Changing Baby - Changing You	31 Sessions
Implementation as Measured by the Number of Sessions Including Each Topic TEAMING UP Together	14 Sessions
Implementation as Measured by the Number of Sessions Including Each Topic Preterm Labor - Warning Signs / Symptoms	7 Sessions
Implementation as Measured by the Number of Sessions Including Each Topic The Labor Process	13 Sessions
Implementation as Measured by the Number of Sessions Including Each Topic Pregnancy Progression	5 Sessions
Implementation as Measured by the Number of Sessions Including Each Topic Late Pregnancy Warning Signs	9 Sessions
Implementation as Measured by the Number of Sessions Including Each Topic Reunion	5 Sessions

PRIMARY outcome

Timeframe: up to 12 weeks after delivery (approximately 1 year)

Intervention sustainability based on continued engagement from the participants

Outcome measures

Measure

Group Social Support Meetings and Facebook Group n=29 Participants Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom

Engagement as Measured by Number of Participants Who Attended More Than One Session

17 Participants

PRIMARY outcome

Timeframe: up to 12 weeks after delivery (approximately 1 year)

Intervention sustainability based on continued engagement from the participants

Outcome measures

Measure

Group Social Support Meetings and Facebook Group n=29 Participants Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom

Engagement as Measured by Number of Participants Who Completed PSA (Pregnancy-specific Anxiety), IPC-18 (Interpersonal Processes of Care), MSSS (Maternal Social Support Scale), and CSQ-9 (Client Satisfaction Questionnaire) at All Time Points

22 Participants

SECONDARY outcome

Timeframe: at intake

Population: Participants who received each question per their IP3 plan.

Questionnaire includes approximately four questions aimed to evaluate a participants knowledge about the details of their IP3 plan. Participants will only receive questions that pertain to their specific IP3. They will be given the answers immediately following the assessment. Understanding of preterm birth and precautions; higher scores better, each questionnaire ranges from 0 to 5 questions correct

Outcome measures

Measure	Group Social Support Meetings and Facebook Group n=29 Participants Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom
IP3 Knowledge Questionnaire Cervix length and cerclage	2.6 score on a scale Standard Deviation 0.6
IP3 Knowledge Questionnaire Progesterone therapy	2.3 score on a scale Standard Deviation 1.0
IP3 Knowledge Questionnaire Low dose aspirin	3.0 score on a scale Standard Deviation 0.9
IP3 Knowledge Questionnaire Lifestyle modification	3.1 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: At intake and at gestational age 20-28 weeks

The PSA is a validated 13-item tool used to assess anxiety specific to pregnancy this tool has been correlated with preterm birth outcome. On a Likert scale of 1 to 5, higher scores indicate greater anxiety.

Outcome measures

Measure	Group Social Support Meetings and Facebook Group n=29 Participants Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom
Pregnancy-specific Anxiety (PSA) At intake	2.7 score on a scale Standard Deviation 1.0
Pregnancy-specific Anxiety (PSA) At Gestational Age 20-28 weeks	2.2 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: at intake

The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured.

Outcome measures

Measure	Group Social Support Meetings and Facebook Group n=29 Participants Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom
Interpersonal Processes of Care (IPC) Lack of clarity	1.9 score on a scale Standard Deviation 0.9
Interpersonal Processes of Care (IPC) Elicited concerns, responded	4.5 score on a scale Standard Deviation 0.6
Interpersonal Processes of Care (IPC) Explained results	4.7 score on a scale Standard Deviation 0.7
Interpersonal Processes of Care (IPC) Decided together	4.4 score on a scale Standard Deviation 0.7
Interpersonal Processes of Care (IPC) Emotional support, compassion	4.7 score on a scale Standard Deviation 0.6
Interpersonal Processes of Care (IPC) Discriminated due to race/ethnicity	1.2 score on a scale Standard Deviation 0.6
Interpersonal Processes of Care (IPC) Disrespectful office staff	1.1 score on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: Gestational age 20-28 weeks

The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured.

Outcome measures

Measure	Group Social Support Meetings and Facebook Group n=29 Participants Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom
Interpersonal Processes of Care (IPC) Lack of clarity	1.4 score on a scale Standard Deviation 0.9
Interpersonal Processes of Care (IPC) Elicited concerns, responded	4.4 score on a scale Standard Deviation 0.8
Interpersonal Processes of Care (IPC) Explained results	4.6 score on a scale Standard Deviation 0.5
Interpersonal Processes of Care (IPC) Decided together	4.4 score on a scale Standard Deviation 0.7
Interpersonal Processes of Care (IPC) Emotional support, compassion	4.6 score on a scale Standard Deviation 0.6
Interpersonal Processes of Care (IPC) Discriminated due to race/ethnicity	1.4 score on a scale Standard Deviation 0.8
Interpersonal Processes of Care (IPC) Disrespectful office staff	1.3 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Gestational age >= 30 weeks

The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured.

Outcome measures

Measure	Group Social Support Meetings and Facebook Group n=29 Participants Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom
Interpersonal Processes of Care (IPC) Lack of clarity	1.8 score on a scale Standard Deviation 0.9
Interpersonal Processes of Care (IPC) Elicited concerns, responded	4.5 score on a scale Standard Deviation 0.6
Interpersonal Processes of Care (IPC) Explained results	4.6 score on a scale Standard Deviation 0.7
Interpersonal Processes of Care (IPC) Decided together	4.5 score on a scale Standard Deviation 0.7
Interpersonal Processes of Care (IPC) Emotional support, compassion	4.6 score on a scale Standard Deviation 0.8
Interpersonal Processes of Care (IPC) Discriminated due to race/ethnicity	1.4 score on a scale Standard Deviation 0.8
Interpersonal Processes of Care (IPC) Disrespectful office staff	1.1 score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: At intake, gestational age 20-28 weeks, and gestational age >=30 weeks

The MSSS is a six-question scale that quantifies a pregnant women's social support as low, medium or adequate. On a Likert scale of 1 to 5, higher scores indicate greater social support.

Outcome measures

Measure	Group Social Support Meetings and Facebook Group n=29 Participants Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom
Maternal Social Support Scale (MSSS) Gestational age >= 30 weeks	27.7 score on a scale Standard Deviation 4.0
Maternal Social Support Scale (MSSS) Gestational age 20-28 weeks	28.2 score on a scale Standard Deviation 3.0
Maternal Social Support Scale (MSSS) At intake	27.3 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: Post delivery (up to approximately 40 weeks)

Population: Participants to which the measure was relevant.

Adherence to the IP3 based on both participant report and EHR chart review; dichotomized as adherent or not adherent.

Outcome measures

Measure	Group Social Support Meetings and Facebook Group n=29 Participants Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom
Number of Participants Who Were Adherent to the IP3 Plan IOM weight gain guidelines	8 Participants
Number of Participants Who Were Adherent to the IP3 Plan Tobacco cessation	2 Participants
Number of Participants Who Were Adherent to the IP3 Plan 17-P	6 Participants
Number of Participants Who Were Adherent to the IP3 Plan Progesterone	0 Participants
Number of Participants Who Were Adherent to the IP3 Plan Cerclage	7 Participants
Number of Participants Who Were Adherent to the IP3 Plan Serial cervix length	6 Participants
Number of Participants Who Were Adherent to the IP3 Plan Low dose aspirin	13 Participants

Adverse Events

Group Social Support Meetings and Facebook Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure

Group Social Support Meetings and Facebook Group n=31 participants at risk Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics. Facebook discussions and Virtual group meetings: Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom

Pregnancy, puerperium and perinatal conditions IUFD (Intrauterine Fetal Demise)

3.2% 1/31 • Up to 12 weeks after delivery (approximately 1 year)

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sarahn Wheeler

Duke University

Phone: 919-668-5462

Email: sarahn.wheeler@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place