Hypertension in Pregnancy
Conditions
Brief summary
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
DRUGLabetalol 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 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with stage 1 HTN 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 146 eligible participants, 73 to active treatment to BP\<130/80mmHg and 73 to usual care.
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Birthweight percentile | at delivery of infant | 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 |
Countries
United States
Contacts
CONTACTDonna Dunn, PhD
CONTACTJhana Plump
Outcome results
None listed