Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Labetalol or Nifedipine.
- Who it may be relevant to
- Registry conditions: Hypertension in Pregnancy. Basic parameters: 14 years — 89 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment of American Heart Association/American College of Cardiology Stage 1 Hypertension in Pregnancy: A Randomized Control Trial
Overview
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.
Interventions
- Drug Labetalol or Nifedipine
The choice of anti-HTN will be based on the patient and provider's experience and preference. First line anti-HTN recommended in pregnancy- labetalol or nifedipine- will be administered to patients. At least weekly, a study team member will review the participants' BPs and, if randomized to intervention and a higher dose is needed to maintain BPs \<130/80 mmHg, the study team member will communicate with the clinical team, led by a University of Alabama Maternal Fetal Medicine Attending, in orde
Primary outcome measures
- Neonatal Birthweight percentile [Time frame: at delivery of infant]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UAB — Birmingham
Identifiers
NCT: NCT05989581 · 3000010726