Improving Women's Health Through Coordinated Postpartum Planning

Minding the Gap: Improving Women's Health Through Coordinated Postpartum Planning

The purpose of the study is to design, implement, and evaluate a holistic postpartum women's health care system for women who have cardiovascular risk factors for severe maternal morbidity (SMM) including chronic hypertension, chronic diabetes, gestational diabetes, pre-pregnancy obesity, or a hypertensive disorder of pregnancy (HDP) which includes gestational hypertension or preeclampsia. The researchers will use a sequential mixed methods design. First, the researchers will conduct in-depth interviews with women who have given birth in the prior year to characterize barriers and facilitators to accessing postpartum care. The information from these interviews will be used to inform the design of a postpartum care system. Next, the researchers will conduct a pragmatic randomized trial to test the effectiveness of the system on postpartum care engagement versus standard of care.

Study Overview

• Status: Completed
• Conditions: Maternal Death; Maternal Morbidity
• Intervention / Treatment: Behavioral: Enhanced Postpartum Care System

Detailed Description

The US maternal mortality ratio is the highest among developed nations at 26.4 maternal deaths per 100,000 live births. Among the states, Georgia has the second highest maternal mortality (66.3 per 100,000), with a 60% higher rate for black vs white women (95.6 vs 59.7 per 100,000). Nearly 100 times more common than maternal mortality is severe maternal morbidity (SMM), defined as unexpected outcomes of labor and delivery that result in short- and long-term deleterious health consequences. Maternal mortality and SMM are highest among women who are black, publicly insured or uninsured, and deliver in safety-net hospitals. In Georgia, 66% of maternal deaths occur to women insured by Medicaid at delivery and the majority of deaths and SMM occur postpartum, a time during which healthcare visits are poorly attended and oftentimes inaccessible. The Georgia Maternal Mortality Review Committee concluded that two-thirds of maternal deaths are preventable, with chronic health conditions, obesity, delays in accessing and fragmentation of care as key contributors. As solutions, it recommends improved prenatal and postpartum follow-up and case management, control of chronic health conditions, and extension of Medicaid coverage beyond 60 days postpartum.

While the postpartum period represents a crucial window of opportunity for promoting women's current and future health, up to 40% of US women do not attend postpartum visits due to structural barriers (e.g., lack of insurance, transportation or childcare) social barriers (e.g., medical mistrust and poor patient-provider relationships) or low perceived utility of postpartum care. Moreover, the lowest rates of postpartum care utilization are concentrated among women with the highest rates of pregnancy complications and chronic conditions (e.g., women who are uninsured or Medicaid-insured, low-income, and non-Hispanic black). Timely and adequate use of postpartum care is especially important for women with diabetes or hypertensive disease as these conditions are associated with increased risk for postpartum morbidity and mortality and cardiovascular disease later in life.

The researchers of this study plan to conduct an intervention study to assess the effect of a woman-centered, comprehensive postpartum care system on postpartum visit attendance and follow-up care among medically underserved women with chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity or hypertensive disorder of pregnancy (HDP). Because implementing and sustaining a comprehensive postpartum care system in a health disparities population requires a thorough understanding of patient preferences regarding the structural and process elements of care, methods of provider-patient communication, and strategies for addressing social and contextual barriers to care the researchers will use in-depth interviews to inform the intervention design and then assess health outcomes and satisfaction.

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• pregnant women between 20-34 weeks of gestation
• have received 1 or more prenatal care visits at Grady Memorial Hospital in Atlanta, Georgia (GA)
• intend to deliver at Grady Memorial Hospital
• speak English or Spanish
• have a diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity (body mass index [BMI] of 30 or greater), and/or a hypertensive disorder of pregnancy (gestational hypertension or preeclampsia) documented in the electronic medical record (EMR)

Exclusion Criteria:

• adults unable to consent, infants, and prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 who are randomized to receive enhanced postpartum care.	Behavioral: Enhanced Postpartum Care System; The intervention 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.
No Intervention: 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 who are randomized to receive standard postpartum care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Attending a Comprehensive Postpartum Visit	The postpartum visit occurs between 4 and 12 weeks after delivery and is 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.	12 weeks after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Risk of Severe Maternal Morbidity (SMM)	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.	12 weeks after delivery
Perceived Risk of Cardiovascular Disease	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.	12 weeks after delivery, 14 months after delivery
Number of Participants Attending Any Postpartum Visit	Any 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.	12 weeks after delivery
Number of Participants for Whom Postpartum Diabetes Screening Was Ordered	Any health care provider order of a postpartum screening for diabetes through laboratory testing was identified using data from medical records.	12 weeks after delivery
Number of Participants for Whom Postpartum Diabetes Screening Was Performed	Any completed postpartum screening for diabetes through laboratory testing was identified using data from medical records.	12 weeks after delivery
Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered	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.	12 weeks after delivery
Number of Participants With Diabetes for Whom Postpartum Screening Was Performed	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.	12 weeks after delivery
Number of Participants Receiving Postpartum Hypertension Screening	Receipt of early postpartum screening (within 0 to 3 weeks of delivery) for hypertension through blood pressure medications identified using data from medical records.	12 weeks after delivery
Number of Participants With Hypertension Receiving Postpartum Hypertension Screening	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.	12 weeks after delivery
Satisfaction With Postpartum Care	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.	12 weeks after delivery
Satisfaction With Provider at Postpartum Care Visit	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.	12 weeks after delivery
Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After 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.	12 weeks after delivery
Number of Participants Using Contraception	The number of participants using contraception is evaluated via patient self-report survey.	12 weeks after delivery, 14 months after delivery
Number of Participants Using Medication	The number of participants using prescription medication for chronic conditions is evaluated via medical record abstraction.	12 weeks after delivery, 14 months after delivery
Number of Participants With Ongoing Pregnancy Complications	The 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.	12 weeks after delivery, 14 months after delivery
Number of Participants Readmitted to the Hospital	The number of participants with any medical complication(s) resulting in hospital readmission since the birth of their baby.	12 weeks after delivery, 14 months after delivery
Number of Participants Using Primary Care	The number of participants attending a visit with a primary care provider is evaluated via medical record abstraction 14 months after delivery.	14 months after delivery
Number of Participants Using Specialty Care	The number of participants attending a visit with a specialty health care provider is evaluated via medical record abstraction 14 months after delivery.	14 months after delivery
Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score	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.	12 weeks after delivery, 14 months after delivery
Number of Participants in Self-rated Categories of Postpartum Health at 14 Months After Delivery	Participants are asked to self-rate their perception of their current health since delivery as "excellent", "very good", "good", "fair", "declined" or "poor". The number of participants endorsing each category of health is presented.	14 months after delivery

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Anne Dunlop, MD, MPH, Emory University

Publications and helpful links

General Publications

• Stanhope KK, Stallworth T, Forrest AD, Vuncannon D, Juarez G, Boulet SL, Geary F, Dunlop AL, Blake SC, Green VL, Jamieson DJ. Planning for the forgotten fourth trimester of pregnancy: A parallel group randomized control trial to test a postpartum planning intervention vs. standard prenatal care. Contemp Clin Trials. 2024 Aug;143:107586. doi: 10.1016/j.cct.2024.107586. Epub 2024 Jun 3.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): April 22, 2025

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Maternal mortality; Postpartum care; Severe maternal morbidity
• Additional Relevant MeSH Terms: Pathologic Processes; Death; Parental Death; Pathological Conditions, Signs and Symptoms; Maternal Death
• Other Study ID Numbers: STUDY00001427; 1R01MD016031 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The final fully deidentified dataset that will be made available for sharing will include sociodemographic, health behavioral, and health care utilization data from both questionnaire and medical record abstraction, to include race/ethnicity, age, insurance type, visits to health care provider/clinic/or hospital within one year postpartum, including any diagnoses, medical testing and/or laboratory screenings (and results of those tests), prescribed medications and adherence to prescribed medications, as well as data related to any subsequently conceived pregnancy.
• IPD Sharing Time Frame: Data will become available one year after study completion (starting May 1, 2025) and will be made available for 5 years (through April 30, 2030).
• IPD Sharing Access Criteria: The researchers will make the data and associated documentation available to users under a data-sharing agreement. Outside researchers must submit a Data Analysis Request Form, which requires elucidation of the specific data requested along with a statement that the investigator must provide: 1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed. The Data Analysis Request Form will be made web-accessible with directions to submit the request for review. Outside investigators must have satisfactorily completed a Data Use and Confidentiality Agreement, before the anonymized data is released.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No