Improving Women's Health Through Coordinated Postpartum Planning

Maternal Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05430815
• Other study ID #: STUDY00001427
• Secondary ID: 1R01MD016031
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The US maternal mortality ratio is the highest among developed nations at 26.4 maternal deaths per 100,000 livebirths. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Maternal Death
• Maternal Morbidity

Intervention

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.

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants attending the postpartum visit	The postpartum visit occurs between 4 and 12 weeks after delivery. Postpartum visit attendance will be identified using data from medical records.	12 weeks after delivery
Secondary	Number of Participants Receiving Postpartum Diabetes Screening	Whether or not a participant received the recommended early postpartum screening for diabetes through glucose testing will be evaluated.	12 weeks after delivery
Secondary	Number of Participants Receiving Postpartum Hypertension Screening	Whether or not a participant received the recommended early postpartum screening for hypertension through blood pressure measurement will be evaluated.	12 weeks after delivery
Secondary	Change in Number of Participants Using Contraception	The number of participants using contraception will be evaluated.	12 weeks after delivery, 14 months after delivery
Secondary	Change in Number of Participants Using Medication	The number of participants using prescription medication for chronic conditions will be evaluated.	12 weeks after delivery, 14 months after delivery
Secondary	Change in Number of Participants with Ongoing Pregnancy Complications	Ongoing complications from pregnancy (including SMM) will be evaluated.	12 weeks after delivery, 14 months after delivery
Secondary	Change in Number of Participants Readmitted to the Hospital	Participants will be asked if they have had any medical complications resulting in hospital readmission since the birth of their baby.	12 weeks after delivery, 14 months after delivery
Secondary	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
Secondary	Change in 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
Secondary	Change in Number of Participants Using Primary Care	The number of participants planning to attend, or have already attended, a visit with a primary care provider will be evaluated.	12 weeks after delivery, 14 months after delivery
Secondary	Change in Number of Participants Using Specialty Care	The number of participants planning to use, or using, specialty health care will be evaluated.	12 weeks after delivery, 14 months after delivery
Secondary	Change in 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 10 and greater indicate possible depression.	12 weeks after delivery, 14 months after delivery
Secondary	Satisfaction with Postpartum Care	Satisfaction with the postpartum checkup is assessed with 4 items asking if participants 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 will be assessed.	12 weeks after delivery
Secondary	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. Total scores range from 4 to 20 where higher scores indicate greater satisfaction with the healthcare provider.	12 weeks after delivery
Secondary	Self-rated Health	Participants are asked to rate their health in general as "excellent", "very good", "good", "fair", or "poor". The number of participants endorsing each category of health will be assessed.	14 months after delivery