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Calcium Channel Blocker

Nifedipine ER for Postpartum High Blood Pressure (IPAT Trial)

Phase 3

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HDP diagnosis (gestational hypertension or preeclampsia) according to ACOG guidelines

Age 18 - 45

Must not have

Pre-gestational diabetes (type 1 or type 2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months postpartum

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to improve maternal cardiovascular health by controlling blood pressure after pregnancy and reducing risk of chronic hypertension.

Who is the study for?

This trial is for women aged 18-45 who have been diagnosed with high blood pressure or pre-eclampsia during pregnancy, according to ACOG guidelines. They must be within the first three days postpartum and able to communicate in English or Spanish. Women with pre-existing hypertension, diabetes before pregnancy, plans to transfer hospitals postpartum, nifedipine allergies, or unwillingness to consent are excluded.

What is being tested?

The study is testing the effects of intensive blood pressure control using NIFEdipine ER after childbirth on long-term cardiovascular health. It aims to reduce chronic hypertension risk and improve vascular function affected by hypertensive disorders during pregnancy.

What are the potential side effects?

NIFEdipine ER may cause side effects such as headache, swelling of the ankles/feet (fluid retention), dizziness/lightheadedness due to low blood pressure, flushing (warmth/redness/itchy feeling under your skin), fatigue, and possibly nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with high blood pressure during pregnancy.

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had diabetes (type 1 or 2) before becoming pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Contamination

Feasibility in randomization

Feasibility in recruitment

+1 more

Secondary study objectives

Flow-mediated dilation

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

Life's Simple 7 CVH (range 0-14)

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention armExperimental Treatment1 Intervention

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.

Group II: Active control armActive Control1 Intervention

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.

0 / 3Eligibility criteria met