Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project
ConditionHypertension in Pregnancy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age14-89
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Labetalol or Nifedipine
Treatment groups
74 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov