Chronic Hypertension and Pregnancy 2 (CHAP2) Pilot Project

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of American Heart Association/American College of Cardiology Stage 1 Hypertension in Pregnancy: A Randomized Control Trial

Conditions
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Hypertension in Pregnancy

Intervention / Treatment
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* Drug: BP <130/80mmHg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 74 eligible participants, 37 to active treatment to BP<130/80mmHg and 37 to usual care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BP goal <130/80mmHg<br> | Drug: BP <130/80mmHg<br>* 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.<br>|
| No Intervention: BP goal <140/90 (usual care)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at delivery of infant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal blood pressure | Systolic and diastolic blood pressure | prenatal, delivery, postpartum up to 6 weeks after delivery | 
| Gestational age at delivery | Gestational age at delivery, preterm birth <37 weeks' gestation, preterm birth<34 weeks' gestation | prenatal, delivery, postpartum up to 6 weeks after delivery | 
| Incidence of Hypertensive disorders of pregnancy | Preeclampsia, eclampsia, gestational hypertension | prenatal, delivery, postpartum up to 6 weeks after delivery | 
| Maternal adverse cardiovascular composite | Heart failure, stroke, myocardial infarction or angina, pulmonary edema, ICU admission, encephalopathy, renal failure, death | prenatal, delivery, postpartum up to 6 weeks after delivery |