Trial Outcomes & Findings for Improving Women's Health Through Coordinated Postpartum Planning (NCT NCT05430815)
NCT ID: NCT05430815
Last Updated: 2025-08-22
Results Overview
The postpartum visit occurs between 4 and 12 weeks after delivery and meets specific, defined as a preventive care visit with an obstetric care provider (e.g., obstetrician-gynecologist, certified nurse midwife, or primary care provider with additional training relevant to postpartum care) that included an assessment of assessing multiple aspects of physical and mental health. Comprehensive postpartum visit attendance was identified using data from medical records using a standardized abstraction form.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
320 participants
Primary outcome timeframe
12 weeks after delivery
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Enhanced Postpartum Care System
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
Enhanced Postpartum Care System consists of a comprehensive postpartum care system that integrates American College of Obstetrician and Gynecologist's (ACOG) postpartum care guidelines together with American College of Cardiology and American Heart Association (ACC/AHA) guidelines for the prevention of cardiovascular disease in women, as well as patient preferences for care coordination and communication. The system consists of: 1) a tailored postpartum care plan that is collaboratively developed with patient and provider input and addresses both social and medical needs; 2) an electronic medical record (EMR) based tool for documenting the plan and monitoring postpartum care; and 3) a postpartum follow-up phone call at 1 week postpartum.
|
Standard of Care
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Overall Study
STARTED
|
159
|
161
|
|
Overall Study
Completed Assessment at 12 Weeks Post-delivery
|
141
|
141
|
|
Overall Study
COMPLETED
|
124
|
117
|
|
Overall Study
NOT COMPLETED
|
35
|
44
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Women's Health Through Coordinated Postpartum Planning
Baseline characteristics by cohort
| Measure |
Enhanced Postpartum Care System
n=159 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=161 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-24
|
42 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Customized
25-34
|
81 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Age, Customized
35-45
|
36 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
159 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
320 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
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
136 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
133 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
159 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Type of health insurance at delivery
Medicaid/Medicare
|
119 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Type of health insurance at delivery
Private insurance
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Type of health insurance at delivery
Self-pay
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Type of health insurance at delivery
Unknown
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Gestational age at study enrollment
20-27 weeks
|
98 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Gestational age at study enrollment
28-34 weeks
|
61 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Documented diagnoses
Chronic hypertension
|
70 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Documented diagnoses
Diabetes mellitus
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Documented diagnoses
Pre-pregnancy obesity
|
79 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Documented diagnoses
Gestational diabetes
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Documented diagnoses
Hypertensive disorders of pregnancy
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after deliveryThe postpartum visit occurs between 4 and 12 weeks after delivery and meets specific, defined as a preventive care visit with an obstetric care provider (e.g., obstetrician-gynecologist, certified nurse midwife, or primary care provider with additional training relevant to postpartum care) that included an assessment of assessing multiple aspects of physical and mental health. Comprehensive postpartum visit attendance was identified using data from medical records using a standardized abstraction form.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=159 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=161 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants Attending a Comprehensive Postpartum Visit
|
84 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after deliveryAny type of outpatient postpartum visit between 4 and 12 weeks after delivery other than visits to urgent care and/or emergency departments. Postpartum visit attendance was identified using data from medical records using a standardized abstraction form.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=159 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=161 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants Attending Any Postpartum Visit
|
109 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after deliveryAny health care provider order of a postpartum screening for diabetes through laboratory testing was identified using data from medical records.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=159 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=161 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants for Whom Postpartum Diabetes Screening Was Ordered
Postpartum diabetes screening ordered
|
18 Participants
|
26 Participants
|
|
Number of Participants for Whom Postpartum Diabetes Screening Was Ordered
Postpartum diabetes screening not ordered
|
141 Participants
|
135 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after deliveryAny completed postpartum screening for diabetes through laboratory testing was identified using data from medical records.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=159 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=161 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants for Whom Postpartum Diabetes Screening Was Performed
Postpartum diabetes screening completed
|
9 Participants
|
14 Participants
|
|
Number of Participants for Whom Postpartum Diabetes Screening Was Performed
Postpartum diabetes screening not completed
|
150 Participants
|
147 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after deliveryPopulation: This analysis includes participants diagnosed with gestational diabetes or diabetes mellitus.
Any health care provider order of a postpartum screening for diabetes through laboratory testing was identified using data from medical records, among enrolled participants diagnosed with gestational diabetes or diabetes mellitus.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=36 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=45 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered
Postpartum diabetes screening ordered
|
14 Participants
|
19 Participants
|
|
Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered
Postpartum diabetes screening not ordered
|
22 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after deliveryPopulation: This analysis includes participants diagnosed with gestational diabetes or diabetes mellitus.
Any completed postpartum screening for diabetes through laboratory testing was identified using data from medical records, among enrolled participants diagnosed with gestational diabetes or diabetes mellitus.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=36 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=45 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants With Diabetes for Whom Postpartum Screening Was Performed
Postpartum diabetes screening completed
|
8 Participants
|
11 Participants
|
|
Number of Participants With Diabetes for Whom Postpartum Screening Was Performed
Postpartum diabetes screening not completed
|
28 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after deliveryReceipt of early postpartum screening (within 0 to 3 weeks of delivery) for hypertension through blood pressure medications identified using data from medical records.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=159 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=161 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants Receiving Postpartum Hypertension Screening
|
80 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after deliveryPopulation: This analysis includes participants diagnosed with hypertensive disorders of pregnancy or chronic hypertension.
Receipt of early postpartum screening (within 0 to 3 weeks of delivery) for hypertension through blood pressure medications identified using data from medical records, among enrolled participants diagnosed with hypertensive disorders of pregnancy or chronic hypertension.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=75 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=78 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants With Hypertension Receiving Postpartum Hypertension Screening
|
45 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after deliveryPopulation: This analysis includes participants who completed the assessment at 12 weeks post-delivery.
The number of participants using contraception is evaluated via patient self-report survey.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=141 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=141 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants Using Contraception 12 Weeks After Delivery
|
119 Participants
|
117 Participants
|
SECONDARY outcome
Timeframe: 14 months after deliveryThe number of participants using contraception is evaluated via patient self-report survey.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks after deliveryThe number of participants using prescription medication for chronic conditions is evaluated via medical record abstraction.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=159 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=161 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants Using Medication 12 Weeks After Delivery
|
21 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 14 months after deliveryThe number of participants using prescription medication for chronic conditions will be evaluated via medical record abstraction.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks after deliveryThe number of participants with diagnoses of severe maternal morbidity since the birth of their baby, identified from medical records using International Classification of Diseases diagnosis and any procedure codes from readmissions following the delivery.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=159 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=161 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants With Ongoing Pregnancy Complications at 12 Weeks After Delivery
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 14 months after deliveryThe number of participants with diagnoses of severe maternal morbidity since the birth of their baby, identified from medical records using International Classification of Diseases diagnosis and any procedure codes from readmissions following the delivery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks after deliveryThe number of participants with any medical complication(s) resulting in hospital readmission since the birth of their baby.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=159 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=161 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants Readmitted to the Hospital at 12 Weeks After Delivery
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 14 months after deliveryThe number of participants with any medical complication(s) resulting in hospital readmission since the birth of their baby.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks after deliveryPopulation: This analysis includes participants who completed the assessment at 12 weeks post-delivery.
Future severe maternal morbidity risk perception is assessed with a single question asking participants if they think they are at higher or lower risk of having a serious pregnancy complication during a future pregnancy compared to other women of the same age. Responses are given on a 3-point scale where 1 = low risk and 3 = high risk.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=141 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=141 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Perceived Risk of Severe Maternal Morbidity (SMM)
Perceived risk value - low risk
|
35 Participants
|
34 Participants
|
|
Perceived Risk of Severe Maternal Morbidity (SMM)
Perceived risk value - average or high risk
|
66 Participants
|
76 Participants
|
|
Perceived Risk of Severe Maternal Morbidity (SMM)
Don't know/refused to answer/missing response
|
40 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after deliveryPopulation: This analysis includes participants who completed the assessment at 12 weeks post-delivery.
Future cardiovascular disease risk perception is assessed with a single question asking participants if they think they are at higher or lower risk of having a heart attack or stroke compared to other women of the same age. Responses are given on a 3-point scale where 1 = low risk and 3 = high risk.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=141 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=141 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Perceived Risk of Cardiovascular Disease at 12 Weeks After Delivery
Low risk
|
55 Participants
|
58 Participants
|
|
Perceived Risk of Cardiovascular Disease at 12 Weeks After Delivery
Average or high risk
|
26 Participants
|
31 Participants
|
|
Perceived Risk of Cardiovascular Disease at 12 Weeks After Delivery
Don't know/refused to answer/missing response
|
60 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: 14 months after deliveryFuture cardiovascular disease risk perception is assessed with a single question asking participants if they think they are at higher or lower risk of having a heart attack or stroke compared to other women of the same age. Responses are given on a 3-point scale where 1 = low risk and 3 = high risk.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 months after deliveryThe number of participants planning to attend, or have already attended, a visit with a primary care provider will be evaluated via medical record abstraction 14 months after delivery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 months after deliveryThe number of participants planning to attend, or having already attended, a visit with a specialty health care will be evaluated via medical record abstraction 14 months after delivery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks after deliveryPopulation: This analysis includes participants who completed the assessment at 12 weeks post-delivery.
Depressive symptoms are assessed with the Edinburgh Postnatal Depression Scale (EPDS). The EPDS includes 10-items asking participants about symptoms of depression that they have experienced in the past 7 days. Responses are given on a 4-point scale where 0 corresponds with the least amount of symptoms and 3 corresponds with the highest amount of symptoms. Total scores range from 0 to 30 with higher scores indicating increased symptoms of depression. Scores of 13 or greater indicate that the respondent is likely suffering from depression.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=141 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=141 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 12 Weeks After Delivery
EPDS score of 13 or higher
|
37 Participants
|
26 Participants
|
|
Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 12 Weeks After Delivery
EPDS score of less than 13
|
88 Participants
|
92 Participants
|
|
Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score at 12 Weeks After Delivery
Refused to answer/missing response
|
16 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 14 months after deliveryDepressive symptoms are assessed with the Edinburgh Postnatal Depression Scale (EPDS). The EPDS includes 10-items asking participants about symptoms of depression that they have experienced in the past 7 days. Responses are given on a 4-point scale where 0 corresponds with the least amount of symptoms and 3 corresponds with the highest amount of symptoms. Total scores range from 0 to 30 with higher scores indicating increased symptoms of depression. Scores of 13 or greater indicate that the respondent is likely suffering from depression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks after deliveryPopulation: This analysis includes participants who reported completing a postpartum visit. Some participants did not respond to every survey item.
Satisfaction with the postpartum checkup is assessed by asking those participants who reported completing a postpartum visit if they were satisfied with the wait time, amount of time with healthcare providers, advice given, and respect shown to each individual as a person. Responses are given as "yes" or "no". The count of participants reporting satisfaction with each separate item is assessed.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=95 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=90 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Satisfaction With Postpartum Care
Satisfied with wait time
|
88 Participants
|
81 Participants
|
|
Satisfaction With Postpartum Care
Satisfied with amount of time with healthcare providers
|
90 Participants
|
79 Participants
|
|
Satisfaction With Postpartum Care
Satisfied with advice given
|
91 Participants
|
82 Participants
|
|
Satisfaction With Postpartum Care
Satisfied with respect shown to each individual as a person
|
93 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after deliveryPopulation: This analysis includes participants who reported completing a postpartum visit. Some participants did not respond to every survey item.
Satisfaction with the healthcare provider at the postpartum care visit is assessed with 4 items. Responses are given on a 5-point scale where 1 = poor and 5 = excellent. Each item is scored separately and higher scores indicate greater satisfaction with the healthcare provider.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=95 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=90 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Satisfaction With Provider at Postpartum Care Visit
Respected me as a person
|
4.7 units on a scale
Standard Deviation 0.6
|
4.7 units on a scale
Standard Deviation 0.5
|
|
Satisfaction With Provider at Postpartum Care Visit
Letting me say what mattered to me about my health
|
4.7 units on a scale
Standard Deviation 0.6
|
4.6 units on a scale
Standard Deviation 0.8
|
|
Satisfaction With Provider at Postpartum Care Visit
Taking my preferences seriously
|
4.7 units on a scale
Standard Deviation 0.7
|
4.6 units on a scale
Standard Deviation 0.8
|
|
Satisfaction With Provider at Postpartum Care Visit
Giving me enough information to make the best decisions about my health
|
4.7 units on a scale
Standard Deviation 0.6
|
4.6 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 12 weeks after deliveryPopulation: This analysis includes participants who completed the assessment at 12 weeks post-delivery.
Participants are asked to self-rate their perception of their physical health and mental health since delivery as "excellent", "very good", "good", "fair", "declined" or "poor". The number of participants endorsing each category of health is presented.
Outcome measures
| Measure |
Enhanced Postpartum Care System
n=141 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=141 Participants
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Mental health since delivery · Declined
|
6 Participants
|
3 Participants
|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Physical Health Since Delivery · Excellent
|
47 Participants
|
50 Participants
|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Physical Health Since Delivery · Very Good
|
18 Participants
|
23 Participants
|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Physical Health Since Delivery · Good
|
43 Participants
|
32 Participants
|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Physical Health Since Delivery · Fair
|
23 Participants
|
24 Participants
|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Physical Health Since Delivery · Declined
|
1 Participants
|
2 Participants
|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Physical Health Since Delivery · Poor
|
5 Participants
|
3 Participants
|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Physical Health Since Delivery · Missing response/refused to answer
|
4 Participants
|
7 Participants
|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Mental health since delivery · Excellent
|
49 Participants
|
53 Participants
|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Mental health since delivery · Very Good
|
21 Participants
|
22 Participants
|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Mental health since delivery · Good
|
26 Participants
|
29 Participants
|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Mental health since delivery · Fair
|
28 Participants
|
24 Participants
|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Mental health since delivery · Poor
|
8 Participants
|
9 Participants
|
|
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery
Mental health since delivery · Missing response/refused to answer
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 14 months after deliveryParticipants are asked to self-rate their perception of their physical health and mental health since delivery as "excellent", "very good", "good", "fair", "declined" or "poor". The number of participants endorsing each category of health is presented.
Outcome measures
Outcome data not reported
Adverse Events
Enhanced Postpartum Care System
Serious events: 6 serious events
Other events: 39 other events
Deaths: 0 deaths
Standard of Care
Serious events: 9 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enhanced Postpartum Care System
n=159 participants at risk
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=161 participants at risk
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Inpatient hospitalization through 12 weeks postpartum for sepsis
|
1.3%
2/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
0.62%
1/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Pregnancy, puerperium and perinatal conditions
Inpatient hospitalization through 12 weeks postpartum for preeclampsia
|
2.5%
4/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
1.2%
2/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Pregnancy, puerperium and perinatal conditions
Inpatient hospitalization through 12 weeks postpartum for eclampsia
|
0.00%
0/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
0.62%
1/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Pregnancy, puerperium and perinatal conditions
Inpatient hospitalization through 12 weeks postpartum for cerebral hemorrhage
|
0.00%
0/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
0.62%
1/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Reproductive system and breast disorders
Inpatient hospitalization through 12 weeks postpartum for endometriosis
|
0.00%
0/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
0.62%
1/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Hepatobiliary disorders
Inpatient hospitalization through 12 weeks postpartum for cholecystitis
|
0.00%
0/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
0.62%
1/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Gastrointestinal disorders
Inpatient hospitalization through 12 weeks postpartum for small bowel obstruction
|
0.00%
0/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
0.62%
1/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Surgical and medical procedures
Inpatient hospitalization through 12 weeks postpartum for colostomy reversal
|
0.00%
0/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
0.62%
1/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
Other adverse events
| Measure |
Enhanced Postpartum Care System
n=159 participants at risk
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive enhanced postpartum care.
|
Standard of Care
n=161 participants at risk
Women with a documented diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, or hypertensive disorder of pregnancy (gestational hypertension or preeclampsia), or pre-pregnancy obesity randomized to receive standard postpartum care.
|
|---|---|---|
|
Reproductive system and breast disorders
Vaginal bleeding
|
0.63%
1/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
1.2%
2/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Pregnancy, puerperium and perinatal conditions
Breastfeeding issues
|
1.3%
2/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
1.2%
2/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Psychiatric disorders
Mental health issues
|
1.9%
3/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
0.00%
0/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.1%
5/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
2.5%
4/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Vascular disorders
Hypertension
|
4.4%
7/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
3.7%
6/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Pregnancy, puerperium and perinatal conditions
New pregnancy
|
0.63%
1/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
0.62%
1/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Infections and infestations
Genitourinary infection
|
2.5%
4/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
0.00%
0/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Surgical and medical procedures
Wound dehiscence or minor infection
|
3.8%
6/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
3.1%
5/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Infections and infestations
Acute upper respiratory, skin, or dental infection
|
6.3%
10/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
3.7%
6/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
General disorders
Chronic condition exacerbation
|
1.9%
3/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
1.2%
2/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Hepatobiliary disorders
Acute cholecystitis
|
1.3%
2/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
0.00%
0/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
|
Reproductive system and breast disorders
Family planning
|
0.00%
0/159 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
0.62%
1/161 • Information on adverse events was collected beginning at the time of informed consent and continued through the first 12 weeks after delivery, and through the final assessment at 14 months after delivery.
In this study, non-serious adverse events are defined as events graded as moderate or higher that resulted in participants seeking care at an emergency department or urgent care center. Serious Adverse Events (SAEs) were defined as: death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon appropriate medical judgment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place