Maternal Death Clinical Trial
Official title:
Minding the Gap: Improving Women's Health Through Coordinated Postpartum Planning
Verified date | June 2024 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 320 |
Est. completion date | April 30, 2025 |
Est. primary completion date | June 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 |
Country | Name | City | State |
---|---|---|---|
United States | Grady Memorial Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
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 |
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