Enhancing Care & Outcomes for Patients During the First Postpartum Year

NCT06615076 | Active Not Recruiting

• 1 other identifier: HP-00107491
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Postpartum Period; Pregnancy; Hypertension, Pregnancy Induced

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  6 and 12 months postpartum

Secondary Outcomes (5)

• Postpartum depression severity assessed using Edinburgh Depression Scale (EPDS)

  6 weeks and 3, 6, and 12 months postpartum

• Postpartum anxiety severity assessed using Generalized Anxiety Disorder Questionnaire (GAD-7)

  6 weeks and 3, 6, and 12 months postpartum

• Change in weight measured by change in kilograms from baseline

  3, 6, and 12 months postpartum

• Maternal satisfaction with postpartum care assessed through surveys/interviews

  3, 6, and 12 months postpartum

• Identification of a primary care provider elicited through interviews

  3, 6, and 12 months postpartum

Study Arms (2)

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.

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).

Other: Postpartum Visits

Interventions

Postpartum Visits OTHER

Postpartum visits with obstetric care providers

Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Less than 18 years of age
• Fetal demise
• No diagnosis of HDP and/or diabetes (pre-gestational or gestational)
• Non-Medicaid insurance coverage

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jenifer Fahey, CNM, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 26, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)