Recruiting

Observational Study

Sponsor:

Medical College of Wisconsin

Code:

NCT06220721

Conditions

Hypertension, Pregnancy-Induced

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nifedipine ER

Study Details

Brief summary:

The long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.

Conditions

Hypertension, Pregnancy-Induced

Study ID

NCT06220721

Start date

Oct 23, 2024

Status verified date

Jul, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Hypertensive disorders of pregnancy (HDP) diagnosis, specifically gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome, according to ACOG guidelines
  • Postpartum day 0-4
  • Age ≥ 18 years
  • Able to communicate in English or in Spanish
  • Has an established OBGYN at an MCW or NU health system practice that has access to Epic electronic medical records.

Exclusion Criteria:

  • Pre-gestational hypertension
  • Type 1 or type 2 diabetes mellitus
  • Admitted to intensive care unit at the time of screening
  • Diagnosed with HDP during postpartum readmission after discharge from delivery hospitalization
  • Getting discharged on the day of screening
  • Known allergy or contraindication to nifedipine ER
  • Inability or unwillingness to provide informed consent
  • Already taking long-acting antihypertensive medication for standard care
  • Maternal conditions that impact study outcomes: sickle cell disease, systemic lupus erythematosus

Study Design

Enrollment

618 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: REPAIR ARM

Intensive postpartum blood pressure control with nifedipine ER initiation at systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg and maintaining blood pressure <140/90 mmHg during the first 6 weeks postpartum.

active comparator: CONTROL ARM

Usual care with nifedipine ER initiation at SBP ≥150 mmHg or DBP ≥100 mmHg and maintaining blood pressure <150/100 mmHg during the first 6 weeks postpartum.

Interventions

Nifedipine ER

Initiation of nifedipine ER postpartum at randomly assigned threshold during the first 6 weeks postpartum.

Primary outcome measure

  • Chronic hypertension [ Time Frame: One year postpartum ]

Central Contacts and Locations

Central contacts

Alyssa M Hernandez, DO

4148055285alyhernandez@mcw.edu

Amandla Stanley, MSN

4148056691akstanley@mcw.edu

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Lynn Yee, MD

lynn.yee@northwestern.edu

Principal Investigator:

Lynn Yee, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Alyssa M Hernandez, DO

4148055285alyhernandez@mcw.edu

Amandla Stanley, MSN

4148056691akstanley@mcw.edu

Principal Investigator:

Anna Palatnik, MD

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-07-20.