Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-09

Study Completion Date

2022-05-10

Brief Summary

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This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features.

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Detailed Description

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This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features.

After diagnosis of preeclampsia with severe features and decision made to proceed with induction of labor. Patients were approached about study and if consented then were then randomized to placebo or nifedipine 30XL daily until delivery occurred.

Conditions

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Preeclampsia Severe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are enrolled and randomly selected to receive Nifedipine or placebo through delivery of her infant.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Nifedipine 30MG

Oral administration of 30mg Nifedipine XL q24 hours until delivery

Group Type ACTIVE_COMPARATOR

Nifedipine 30 MG

Intervention Type DRUG

Nifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure.

Placebo

Matching placebo group q24hrs until delivery

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.

Interventions

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Nifedipine 30 MG

Nifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure.

Intervention Type DRUG

Placebos

At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women aged 18-45 with a viable single or twin intrauterine pregnancy between 22 0/7 and 41 6/7 weeks gestation based on the best obstetric estimate by The American College of Obstetricians and Gynecologists (ACOG) criteria.
* Diagnosis of preeclampsia with severe features with decision made to induce labor. The patient may or may not have already received acute treatment for severe blood pressures.

Exclusion Criteria

* Known allergy or adverse reaction to Nifedipine or any medical condition where Nifedipine is contraindicated, such as galactose intolerance, severe gastrointestinal (GI) structure, and GI hypomotility disorder.
* Currently receiving Nifedipine XL as part of hypertension management prior to induction of labor
* Participation in another trial that affects the primary outcome without prior approval
* Physician/provider or patient refusal
* Participation in this trial in a prior pregnancy
* Triplet or higher order pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No