Postpartum Hypertension Study

Columbia University

Status and phase: Enrolling; Phase 4

Conditions: Pregnancy-Induced Hypertension in Postpartum; Postpartum Pregnancy-Induced Hypertension; Hypertensive Emergency; Postpartum Preeclampsia

Treatments: Drug: Nifedipine; Drug: Labetalol

Study type: Interventional

Funder types: Other

Identifiers

NCT05139238

AAAT5925

Details and patient eligibility

About

The purpose of this study is to assess which blood pressure medication (intravenous labetalol or oral nifedipine) works better in treating severely elevated blood pressure in women who have just delivered a baby.

Full description

Hypertensive emergencies cause significant maternal morbidity and mortality in the postpartum period. In order to reduced these risks, the recommendation is to treat women with severe range blood pressure with either intravenous labetalol or oral nifedipine; it is unclear which medication is superior. The objective of this study is to prospectively enroll women who have hypertensive emergencies in the postpartum period; women will be randomized in a 1:1 fashion and treated with one of the two antihypertensives to see which one works better.

Enrollment: 104 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Patients admitted to labor and delivery (L&D) with blood pressure (BP) in severe range, defined as a systolic ≥160 mm Hg and/or diastolic ≥110 mm Hg
• Postpartum, immediately to 6 weeks postpartum
• With a prior diagnosis of chronic hypertension (not on medication) or hypertensive disorder of pregnancy

Exclusion criteria

• They may not have previously had exposure to either study medication within the previous 24-hour period.
• Patients with a known atrial-ventricular heart block or moderate to severe bronchial asthma will be excluded, or other contraindication to receiving either study medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

104 participants in 2 patient groups

Oral Nifedipine

Active Comparator group

Description:

Oral nifedipine: Once diagnosis of hypertensive emergency is confirmed on repeat blood pressure, patients randomized to oral nifedipine will receive 10mg initially, with repeated doses of 20mg every 20min, for up to a maximum of 5 doses or until the therapeutic blood pressure goal of \<160 systolic and \<105 diastolic is achieved. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.

Treatment:

Drug: Nifedipine

Intravenous labetalol

Active Comparator group

Description:

Intravenous Labetalol: Patients randomized to IV labetalol will receive 20mg initially, followed by escalating doses of 40mg, 80mg, 80mg, then 80mg every 20 minutes until the therapeutic goal is achieved, for a maximum of 5 doses. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.

Treatment:

Drug: Labetalol