Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project
Recruiting · NCT05989581 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alabama at Birmingham
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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
Where it is running
1 location listed across 1 US state.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →