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

Study Overview
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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.

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.

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

Conditions
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Preeclampsia Severe

Intervention / Treatment
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* Drug: Nifedipine 30 MG
* Drug: Placebos


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Parallel Assignment
Interventional Model Description: Patients are enrolled and randomly selected to receive Nifedipine or placebo through delivery of her infant.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nifedipine 30MG<br>Oral administration of 30mg Nifedipine XL q24 hours until delivery | Drug: Nifedipine 30 MG<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Matching placebo group q24hrs until delivery | Drug: Placebos<br>* At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo | Measured acute antihypertension therapy between enrollment and delivery | Between enrollment and delivery, assessed up to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Stratified by Route of Delivery |  | At delivery | 
| Number of Participants With Various Indications for Cesarean Delivery | Some participants could have more than one indication for Cesarean Delivery. | Between enrollment and delivery, assessed up to 18 weeks | 
| Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy |  | Between enrollment and delivery, assessed up to 18 weeks | 
| Number of Participants Who Required Acute Antihypertension Treatments Postpartum |  | At delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia severe, Nifedipine 30MG, placebo controlled