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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months postpartum
Awards & highlights

IPAT Trial 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.Check my eligibility
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.See study design
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.

IPAT Trial 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.

IPAT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Contamination
Feasibility in randomization
Feasibility in recruitment
+1 more
Secondary outcome measures
Flow-mediated dilation
Life's Essential 8 cardiovascular health score (range 0-100)
Life's Simple 7 CVH (range 0-14)
+3 more

IPAT 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.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,653 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent are patients safeguarded when they participate in the intervention arm of this experiment?

"Considering the Phase 3 status of this trial, our team at Power scored the safety profile of Intervention arm as a 3 due to pre-existing evidence demonstrating efficacy and multiple rounds confirming its security."

Answered by AI

To what extent is enrollment available for this research program?

"Affirmative. Clinicaltrials.gov holds the records of this clinical trial which was first posted on September 1st 2023 and has been actively recruiting ever since, with a target of 60 patients at one site."

Answered by AI

Does the research include elderly volunteers of seventy-five years or more?

"According to the inclusion criteria, only individuals aged 18-45 are eligible for this clinical trial. However, there are 73 trials which involve patients younger than 18 and 752 that target those who are over 65 years old."

Answered by AI

What aims has this investigation been designed to accomplish?

"Over a 12 month period postpartum, data will be collected in order to track Contamination. Other outcomes such as Brachial artery Flow-mediated dilation for evaluating endothelial dysfunction, Life's Simple 7 CVH (which excludes sleep), and New stage I hypertension (systolic BP ≥130/80 mmHg) are also being tracked."

Answered by AI

Does this research program currently accept participants?

"Affirmative. Per the clinicaltrials.gov page, this medical trial is actively enrolling participants as of October 21st 2023. The study was initially posted on September 1st and requires a total of 60 patients from one centre to meet its recruitment goals."

Answered by AI

Could I potentially enroll in this medical experiment?

"This experiment is seeking 60 individuals between 18-45 years old who have been diagnosed with pre-eclampsia. To be eligible, applicants must meet the criteria outlined by ACOG (gestational hypertension or preeclampsia), currently be postpartum day 0-3 prior to discharge, and speak either English or Spanish fluently."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intensive Postpartum Antihypertensive Treatment
Anna Palatnik, MD 2023. "Intensive Postpartum Antihypertensive Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05687344.
~40 spots leftby Mar 2026
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