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New treatment option for Hypertension in Pregnancy
Official title Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project
ClinicalTrials.gov ID: NCT05989581
What this study is testing
What is Labetalol or Nifedipine?
Labetalol or Nifedipine is an investigational medicine, given as an once-weekly, being studied as a potential treatment for hypertension in pregnancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 89, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 14 years to 89 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.