Postpartum PeriodNCT06615076
Enhancing Care & Outcomes for Patients During the First Postpartum Year
A study testing Postpartum Visits in people with Postpartum Period and Pregnancy, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The United States is in the midst of a maternal mortality and morbidity crisis, with more than half of maternal deaths occurring within the first postpartum year. Patients with hypertensive disorders of pregnancy (HDP) and diabetes have been found to be particularly high-risk, as they have a significantly increased… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Period, Pregnancy, Hypertension, Pregnancy Induced
- What is being tested?
- Postpartum Visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Pregnant individuals
- Planning to deliver and continue postpartum care at the University of Maryland Medical Center
- Diagnosis of HDP or diabetes (pre-gestational or gestational) before discharge from admission for delivery
- Medicaid insurance coverage
Who cannot join
- Less than 18 years of age
- Fetal demise
- No diagnosis of HDP and/or diabetes (pre-gestational or gestational)
- Non-Medicaid insurance coverage
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: Enhancing Care and Outcomes for Patients With Hypertensive Disorders of Pregnancy and Diabetes During the First Postpartum Year: A Randomized Control Trial
The United States is in the midst of a maternal mortality and morbidity crisis, with more than half of maternal deaths occurring within the first postpartum year. Patients with hypertensive disorders of pregnancy (HDP) and diabetes have been found to be particularly high-risk, as they have a significantly increased risk for the development of cardiovascular disease in the long-term postpartum period. Traditionally, postpartum care has consisted of a single office visit at six weeks postpartum. Recent research has suggested that postpartum care should be an ongoing process, tailored to each woman's specifics needs. The purpose of this research study is to evaluate the effectiveness of obstetric care providers as primary care providers for patients at increased risk of maternal morbidity and mortality in the full first postpartum year.
Read the detailed description
Maternal mortality rates (MMR) and rates of pregnancy-related deaths continue to worsen in the United States (U.S.), with more women dying per capita as a result of complications from pregnancy and childbirth than in any other high-income nation. Persistent and stark racial disparities exist in U.S. rates of maternal deaths and severe maternal morbidity, with Black women being 2.6 times more likely to die than White women. The Centers for Disease Control \& Prevention (CDC) estimate that 69% of pregnancy-related deaths occur within the postpartum period, with 36% occurring up to one week after delivery and 33% occurring up to one year after delivery. It is estimated that 60% of maternal deaths are preventable. This fact, along with the rise in postpartum maternal mortality suggests there are unmet medical needs during this time interval.
Hypertensive disorders in pregnancy (HDP), defined as pre-pregnancy (chronic) or pregnancy-associated hypertension, are the most common complication observed during pregnancy, affecting 8%-10% of all pregnancies in the United States. HDP continue to be among the leading causes of pregnancy-related maternal mortality worldwide and contribute to 7% of pregnancy-related maternal deaths in the United States annually. Additionally, the rates of HDP align with the racial disparities seen in maternal morbidity and mortality, with Black and American Indian and Alaska Native women being affected two to three times more than non-Hispanic White women. Despite being a leading cause of severe maternal morbidity and mortality during pregnancy and in the postpartum period, HDPs are preventable. Close monitoring of BP and timely intervention are essential for reducing morbidity in women with HDP, especially preeclampsia, due to the progressive nature of the disease. The American College of Obstetricians and Gynecologists (ACOG) recommends BP monitoring throughout pregnancy, as well as at 72-hour postpartum and again between 7-10 days postpartum.
The prevalence of gestational diabetes, which is the onset of glucose intolerance within pregnancy, has steadily risen in the United States, increasing from 6.0% in 2016 to 8.3% in 2021. Gestational diabetes has become an indicator of future cardiovascular disease and an established threat of maternal morbidity and mortality. Accordingly, the American College of Obstetricians and Gynecologists (ACOG) and the American Diabetes Association (ADA) stress the importance of screening women with a prior diagnosis of gestational diabetes for continued glucose intolerance at six weeks postpartum and at least once every 3 years after pregnancy.
ACOG states that the weeks following birth are a critical period for a woman and her infant, setting the stage for long-term health outcomes and well-being. ACOG recommends postpartum care should be an ongoing process rather than a single encounter to optimize the health of women and infants. Postpartum follow-up beyond the traditional 6-week visit is particularly important for women with medical complications during pregnancy. Lack of insurance and lack of primary care provider have been cited as obstacles to this follow-up in low-income individuals. Research suggests that obstetric care providers can be effective PCPs and that many patients of reproductive age consider and prefer their obstetric or gynecologic care provider to be their PCP and may not visit another PCP regularly.
The Maryland legislature recently passed Senate Bill 923 which requires Medicaid to extend postpartum coverage for eligible pregnant women from 2 months to 12 months immediately following the end of the women's pregnancy. Postpartum coverage changes began April 1, 2022. Maryland is nationally on the forefront of this initiative, with few other states having enacted this legislation previously. The University of Maryland Medical System is uniquely poised and obligated, as Maryland's state hospital and hospital network, to enact proactive workflows and interventions to take advantage of this Medicaid expansion to improve patient care and outcomes for patients who develop hypertensive disorders of pregnancy during the first year postpartum. Patients of color and patients who receive Medicaid are disproportionately at risk for HDP and diabetes, are a large part of the systems patient population, and could benefit from increased longitudinal care with their OB providers.
- Being tested
- Postpartum Visits
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum VisitsOther
Postpartum visits with obstetric care providers
Postpartum VisitsOther
Postpartum visits with study RN.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will have scheduled structured postpartum visits at 3, 6, and 12 months with obstetric care providers. These structured visits will be targeted at both managing current hypertensive and/or diabetes disorders and decreasing the risk of developing these disorders. Additional postpartum and primary care concerns will also be addressed as they arise. Receives: Other: Postpartum Visits |
| Control | Active comparator | The control group will have study assessment visits at 3, 6, and 12 months during the first postpartum year, conducted by a Registered Nurse (RN). Receives: Other: Postpartum Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure measurement from baseline
Diagnosis and treatment of hypertension through systolic blood pressure measurement by 12 months postpartum. An increase in systolic blood pressure would indicate continued and/or worsening hypertension.
Measured: 6 weeks, 3, 6, and 12 months postpartum
Change in diastolic blood pressure measurement form baseline
Diagnosis and treatment of hypertension through diastolic blood pressure measurement by 12 months postpartum. An increase in diastolic blood pressure would indicate continued and/or worsening hypertension.
Measured: 6 weeks, 3, 6, and 12 months postpartum
Change from baseline in blood glucose level measured by fingerstick
Diagnosis and treatment of diabetes through blood glucose measurement by fingerstick by 12 months postpartum. An increase from baseline in blood glucose would indicate diabetes.
Measured: 6 weeks, 3, 6, and 12 months postpartum
Change in serum A1C level from baseline
Diagnosis and treatment of diabetes through serum A1C measurement by 12 months postpartum. An increase in A1C levels would indicate pre-diabetes or diabetes.
Measured: 6 and 12 months postpartum
Secondary outcomes (5)
Postpartum depression severity assessed using Edinburgh Depression Scale (EPDS)
Patient screening using the Edinburgh Perinatal Depression Scale (EPDS), which is a 10-item validated scale that measures depressive symptoms and is designed for use with pregnant and postpartum women. Each question has four ordinal response options, which can give a total score from 0 to 30, with higher scores indicating more severe symptoms.
Measured: 6 weeks and 3, 6, and 12 months postpartum
Postpartum anxiety severity assessed using Generalized Anxiety Disorder Questionnaire (GAD-7)
Patient screening using the Generalized Anxiety Disorder Questionnaire (GAD-7), a 7-item validated scale used to screen for symptoms of anxiety. The questions can yield a total score between 0-21, with higher scores indicating more severe symptoms.
Measured: 6 weeks and 3, 6, and 12 months postpartum
Change in weight measured by change in kilograms from baseline
Measurement of postpartum weight loss
Measured: 3, 6, and 12 months postpartum
Maternal satisfaction with postpartum care assessed through surveys/interviews
Assessment of maternal satisfaction with postpartum care elicited through self-administered surveys and/or provider interviews.
Measured: 3, 6, and 12 months postpartum
Identification of a primary care provider elicited through interviews
Identification of a primary care provider elicited through interviews with providers
Measured: 3, 6, and 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start12 Nov 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum PeriodStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenifer Fahey, University of Maryland, Baltimore
- Investigators
- Jenifer Fahey, CNM, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615076
- Sponsor's protocol ID
- HP-00107491
- Status last verified
- Mar 2026
- First submitted
- 12 Sep 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Care and Outcomes for Patients With Hypertensive Disorders of Pregnancy and Diabetes During the First Postpartum Year: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06615076
- Acronym / sponsor ID
- HP-00107491
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The United States is in the midst of a maternal mortality and morbidity crisis, with more than half of maternal deaths occurring within the first postpartum year. Patients with hypertensive disorders of pregnancy (HDP) and diabetes have been found to be particularly high-risk, as they have a significantly increased risk for the development of cardiovascular disease in the long-term postpartum period. Traditionally, postpartum care has consisted of a single office visit at six weeks postpartum. Recent research has suggested that postpartum care should be an ongoing process, tailored to each woman's specifics needs. The purpose of this research study is to evaluate the effectiveness of obstetric care providers as primary care providers for patients at increased risk of maternal morbidity and mortality in the full first postpartum year.
Detailed description
Maternal mortality rates (MMR) and rates of pregnancy-related deaths continue to worsen in the United States (U.S.), with more women dying per capita as a result of complications from pregnancy and childbirth than in any other high-income nation. Persistent and stark racial disparities exist in U.S. rates of maternal deaths and severe maternal morbidity, with Black women being 2.6 times more likely to die than White women. The Centers for Disease Control \& Prevention (CDC) estimate that 69% of pregnancy-related deaths occur within the postpartum period, with 36% occurring up to one week after delivery and 33% occurring up to one year after delivery. It is estimated that 60% of maternal deaths are preventable. This fact, along with the rise in postpartum maternal mortality suggests there are unmet medical needs during this time interval.
Hypertensive disorders in pregnancy (HDP), defined as pre-pregnancy (chronic) or pregnancy-associated hypertension, are the most common complication observed during pregnancy, affecting 8%-10% of all pregnancies in the United States. HDP continue to be among the leading causes of pregnancy-related maternal mortality worldwide and contribute to 7% of pregnancy-related maternal deaths in the United States annually. Additionally, the rates of HDP align with the racial disparities seen in maternal morbidity and mortality, with Black and American Indian and Alaska Native women being affected two to three times more than non-Hispanic White women. Despite being a leading cause of severe maternal morbidity and mortality during pregnancy and in the postpartum period, HDPs are preventable. Close monitoring of BP and timely intervention are essential for reducing morbidity in women with HDP, especially preeclampsia, due to the progressive nature of the disease. The American College of Obstetricians and Gynecologists (ACOG) recommends BP monitoring throughout pregnancy, as well as at 72-hour postpartum and again between 7-10 days postpartum.
The prevalence of gestational diabetes, which is the onset of glucose intolerance within pregnancy, has steadily risen in the United States, increasing from 6.0% in 2016 to 8.3% in 2021. Gestational diabetes has become an indicator of future cardiovascular disease and an established threat of maternal morbidity and mortality. Accordingly, the American College of Obstetricians and Gynecologists (ACOG) and the American Diabetes Association (ADA) stress the importance of screening women with a prior diagnosis of gestational diabetes for continued glucose intolerance at six weeks postpartum and at least once every 3 years after pregnancy.
ACOG states that the weeks following birth are a critical period for a woman and her infant, setting the stage for long-term health outcomes and well-being. ACOG recommends postpartum care should be an ongoing process rather than a single encounter to optimize the health of women and infants. Postpartum follow-up beyond the traditional 6-week visit is particularly important for women with medical complications during pregnancy. Lack of insurance and lack of primary care provider have been cited as obstacles to this follow-up in low-income individuals. Research suggests that obstetric care providers can be effective PCPs and that many patients of reproductive age consider and prefer their obstetric or gynecologic care provider to be their PCP and may not visit another PCP regularly.
The Maryland legislature recently passed Senate Bill 923 which requires Medicaid to extend postpartum coverage for eligible pregnant women from 2 months to 12 months immediately following the end of the women's pregnancy. Postpartum coverage changes began April 1, 2022. Maryland is nationally on the forefront of this initiative, with few other states having enacted this legislation previously. The University of Maryland Medical System is uniquely poised and obligated, as Maryland's state hospital and hospital network, to enact proactive workflows and interventions to take advantage of this Medicaid expansion to improve patient care and outcomes for patients who develop hypertensive disorders of pregnancy during the first year postpartum. Patients of color and patients who receive Medicaid are disproportionately at risk for HDP and diabetes, are a large part of the systems patient population, and could benefit from increased longitudinal care with their OB providers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Postpartum VisitsThe intervention group will have scheduled structured postpartum visits at 3, 6, and 12 months with obstetric care providers. These structured visits will be targeted at both managing current hypertensive and/or diabetes disorders and decreasing the risk of developing these disorders. Additional postpartum and primary care concerns will also be addressed as they arise. |
| Control | Active comparator | Other: Postpartum VisitsThe control group will have study assessment visits at 3, 6, and 12 months during the first postpartum year, conducted by a Registered Nurse (RN). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Pregnant individuals
- Planning to deliver and continue postpartum care at the University of Maryland Medical Center
- Diagnosis of HDP or diabetes (pre-gestational or gestational) before discharge from admission for delivery
- Medicaid insurance coverage
Key exclusion criteria (4 listed)
- Less than 18 years of age
- Fetal demise
- No diagnosis of HDP and/or diabetes (pre-gestational or gestational)
- Non-Medicaid insurance coverage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postpartum VisitsPostpartum visits with obstetric care providers | Other | Intervention |
| Postpartum VisitsPostpartum visits with study RN. | Other | Control |
Primary outcome
Change in systolic blood pressure measurement from baseline
Time frame: 6 weeks, 3, 6, and 12 months postpartum
Diagnosis and treatment of hypertension through systolic blood pressure measurement by 12 months postpartum. An increase in systolic blood pressure would indicate continued and/or worsening hypertension.
Change in diastolic blood pressure measurement form baseline
Time frame: 6 weeks, 3, 6, and 12 months postpartum
Diagnosis and treatment of hypertension through diastolic blood pressure measurement by 12 months postpartum. An increase in diastolic blood pressure would indicate continued and/or worsening hypertension.
Change from baseline in blood glucose level measured by fingerstick
Time frame: 6 weeks, 3, 6, and 12 months postpartum
Diagnosis and treatment of diabetes through blood glucose measurement by fingerstick by 12 months postpartum. An increase from baseline in blood glucose would indicate diabetes.
Change in serum A1C level from baseline
Time frame: 6 and 12 months postpartum
Diagnosis and treatment of diabetes through serum A1C measurement by 12 months postpartum. An increase in A1C levels would indicate pre-diabetes or diabetes.
5 secondary outcomes
Postpartum depression severity assessed using Edinburgh Depression Scale (EPDS)
Time frame: 6 weeks and 3, 6, and 12 months postpartum
Postpartum anxiety severity assessed using Generalized Anxiety Disorder Questionnaire (GAD-7)
Time frame: 6 weeks and 3, 6, and 12 months postpartum
Change in weight measured by change in kilograms from baseline
Time frame: 3, 6, and 12 months postpartum
Maternal satisfaction with postpartum care assessed through surveys/interviews
Time frame: 3, 6, and 12 months postpartum
Identification of a primary care provider elicited through interviews
Time frame: 3, 6, and 12 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenifer Fahey, CNM, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postpartum Visits in people with Postpartum Period and Pregnancy, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure measurement from baseline (time frame: 6 weeks, 3, 6, and 12 months postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.