NCT05687344

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

2.5 years

First QC Date

January 1, 2023

Last Update Submit

October 21, 2025

Conditions

Hypertensive Disorder of Pregnancy

Outcome Measures

Primary Outcomes (4)

  • Feasibility in randomization

    Proportion of patients who enroll out of all approached, eligible patients.

    12 months postpartum

  • Feasibility in recruitment

    Number of patients successfully enrolled per month during the study.

    12 months postpartum

  • Feasibility in retention

    Proportion of enrolled patients who complete all study visits during the 12 months follow-up.

    12 months postpartum

  • Contamination

    Percent of patients following other antihypertensive treatment regimens.

    12 months postpartum

Secondary Outcomes (6)

  • New stage I hypertension

    12 months postpartum

  • Life's Essential 8 cardiovascular health score (range 0-100)

    12 months postpartum

  • Life's Simple 7 CVH (range 0-14)

    12 months postpartum

  • Flow-mediated dilation

    12 months postpartum

  • Serum biomarkers of CVD risk

    12 months postpartum

  • +1 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

Intervention group - intensive postpartum BP control with Nifedipine initiation at SBP≥140 mmHg or DBP≥90 mmHg and maintaining BP at \<140/90 mmHg during the first 6 weeks postpartum. In addition, participants will receive education on healthy lifestyle following AHA LE8.

Drug: Nifedipine ER

Active control arm

ACTIVE COMPARATOR

Active control group - a group of usual care that follows ACOG recommendations with Nifedipine initiation at SBP≥150 mmHg or DBP≥100 mm Hg and maintaining BP at \<150/100 mmHg during the first 6 weeks postpartum. In addition, participants will receive education on healthy lifestyle following AHA LE8.

Drug: Nifedipine ER

Interventions

Nifedipine ERDRUG

Postpartum BP treatment to \<140/90 mmHg

Also known as: Tight BP control group
Active control armIntervention arm

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HDP diagnosis (gestational hypertension or preeclampsia) according to ACOG guidelines
  • Postpartum day 0-3 and prior to discharge
  • Able to communicate in English or in Spanish
  • Age 18 - 45

You may not qualify if:

  • Pre-gestational hypertension
  • Pre-gestational diabetes ( type 1 or type 2)
  • Intent to transfer postpartum to an outside institution of the participating centers
  • Known allergy to nifedipine or other significant contraindication to nifedipine
  • Inability or unwillingness to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Palatnik A, Sunji N, Peterson Z, Ohlendorf J, Pan AY, Kulinski J. Intensive postpartum antihypertensive treatment (IPAT) and healthy lifestyle education: Study protocol for a pilot randomized controlled trial for patients with hypertensive disorders of pregnancy. Contemp Clin Trials. 2024 Dec;147:107710. doi: 10.1016/j.cct.2024.107710. Epub 2024 Oct 10.

    PMID: 39395531DERIVED

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 18, 2023

Study Start

September 1, 2023

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

October 23, 2025

Record last verified: 2025-10

Locations

US(1)