Postpartum Hypertension Study

Sponsor

Columbia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05139238

Collaborator

(none)

280

Enrollment

Location

Arms

Anticipated Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Pregnancy-Induced Hypertension Postpartum Preeclampsia Pregnancy-Induced Hypertension in Postpartum Hypertensive Emergency	Drug: Labetalol Drug: Nifedipine	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Oral Nifedipine Versus Intravenous Labetalol for Postpartum (PP) Hypertensive Emergency: A Randomized Clinical Trial (RCT)

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oral Nifedipine 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.	Drug: Nifedipine Oral nifedipine, a short acting ant-hypertensive Other Names: Oral Procardia
Active Comparator: Intravenous labetalol 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.	Drug: Labetalol Intravenous labetalol, a short acting ant-hypertensive

Arm

Intervention/Treatment

Active Comparator: Oral Nifedipine

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.

Drug: Nifedipine

Oral nifedipine, a short acting ant-hypertensive

Other Names:

Oral Procardia

Active Comparator: Intravenous labetalol

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.

Drug: Labetalol

Intravenous labetalol, a short acting ant-hypertensive

Outcome Measures

Primary Outcome Measures

Average Time to Initial Blood Pressure Control (minutes) [Up to 48 hours]
The primary outcome will be time (minutes) interval required to achieve the therapeutic BP goal of <160 mmHg systolic and <110 mmHg diastolic.

Secondary Outcome Measures

Average Number of Recurrence of Severe Blood Pressure [Up to 48 hours]
The number of times a patient has recurrence of severe hypertensive necessitating treatment with an antihypertensive.
Total Number of Participants Who Need for Second Antihypertensive Agent [Up to 48 hours]
The need to use a second (alternative) antihypertensive medication.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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