RecruitingPhase 1

Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

United States74 participantsStarted 2024-04-24

Plain-language summary

The CHAP2 study is designed to provide preliminary data for a larger multicenter study to assess whether treatment of stage 1 hypertension (HTN) in pregnancy improves maternal and or neonatal outcomes. The primary objective of this pilot study is to determine if anti-HTN treatment to BP\<130/80mmHg in pregnant patients with stage 1 HTN is associated with a difference in birthweight percentile at delivery. Patients with stage 1 hypertension in pregnancy will be randomized to BP goals of \<130/80mmHg or usual care to treatment only if BPs ≥140/90mmHg. For this pilot, the investigator will randomize a total of 74 eligible participants, 37 to active treatment to BP\<130/80mmHg and 37 to usual care.

Who can participate

Age range

14 Years – 89 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Viable singleton gestation * No fetal anomalies * Blood pressures 130-139/80-89mmHg on two occasions at least 4 hours apart prior to 20 weeks gestation * Planning to deliver at UAB Hospital * No indication for pregnancy termination * Receiving care at the UAB prenatal clinics Exclusion Criteria: * Declines Randomization * Known diagnosis of chronic hypertension ( BP ≥ 140/90mmHg) or current antihypertensive medication use * Fetal demise diagnosed prior to enrollment * Known major structural of chromosomal abnormalities prior to enrollment * Contraindication to first line antihypertensive (Nifedipine/ Labetalol) * Comorbidities requiring BP goals \< 130/80mmHg

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neonatal Birthweight percentile

Timeframe: at delivery of infant

Trial details

NCT IDNCT05989581

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Donna Dunn, PhD

12058739503 dcampbell@uabmc.edu

View on ClinicalTrials.gov More Hypertension in Pregnancy trials