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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Labetalol or Nifedipine
DrugThe 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 order to ensure coordination between the research and clinical care teams. Labetalol will be initiated at 200 mg twice daily and escalated in 200mg /dose daily until BP\<130/80mmHg to a maximum dose of 2400mg/day. Procardia will be initiated at 30mg XL once daily and uptitrated in 30mg increments until a maximum dose of 120mg daily. Postpartum, titration will occur in similar fashion. The patient will be transitioned to her primary care provider for BP management after the 6-week postpartum visit.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: BP goal <130/80mmHgExperimental treatment 1 intervention
Group B: BP goal <140/90 (usual care)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Neonatal Birthweight percentile
To determine whether anti-HTN treatment to BP\<130/80mmHg in pregnant patients with Stage 1 HTN is associated with a difference in birthweight percentile at delivery
Time frame
at delivery of infantSponsors and contacts
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Source ClinicalTrials.gov