Postpartum Hypertension Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pregnancy-Induced Hypertension in Postpartum, Postpartum Pregnancy-Induced Hypertension, Postpartum Preeclampsia, Hypertensive Emergency

Intervention / Treatment
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* Drug: Labetalol
* Drug: Nifedipine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Nifedipine<br>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<br>* Oral nifedipine, a short acting ant-hypertensive<br>* Other names: Oral Procardia;|
| Active Comparator: Intravenous labetalol<br>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<br>* Intravenous labetalol, a short acting ant-hypertensive<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Hypertensive Emergency, Postpartum, Preeclampsia