Improving Women's Health Through Coordinated Postpartum Planning

NCT05430815 | Completed Results DMC

• 2 other identifiers: STUDY000014271R01MD016031
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maternal Morbidity; Maternal Death

Keywords

Maternal mortality; Severe maternal morbidity; Postpartum care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Number of Participants Attending Any Postpartum Visit

  12 weeks after delivery

• Number of Participants for Whom Postpartum Diabetes Screening Was Ordered

  12 weeks after delivery

• Number of Participants for Whom Postpartum Diabetes Screening Was Performed

  12 weeks after delivery

• Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered

  12 weeks after delivery

• Number of Participants With Diabetes for Whom Postpartum Screening Was Performed

  12 weeks after delivery

Study Arms (2)

Enhanced Postpartum Care System

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Enhanced Postpartum Care System BEHAVIORAL

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.

Enhanced Postpartum Care System

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• adults unable to consent, infants, and prisoners

Sponsors & Collaborators

• Emory University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

• 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.

  PMID: 38838985 DERIVED

MeSH Terms

Conditions

Maternal Death

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anne Dunlop, MD, MPH
• Organization: Emory University

amlang@emory.edu

404-712-8520

Study Officials

• Anne Dunlop, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Information on all outpatient visits occurring between delivery discharge and 12 weeks postpartum will be abstracted and blinded for review. Two independent physicians will review the blinded information and determine whether the visit meets the criteria for a comprehensive postpartum visit.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: August 8, 2022
• Primary Completion: July 31, 2024
• Study Completion: April 22, 2025
• Last Updated: May 14, 2026
• Results First Posted: August 22, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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).
• 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.

Locations

US (1)