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Clinical trial

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

ID
Name
2019H0431
Description
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.
Trial arms
Trial start
2020-06-09
Estimated PCD
2022-04-20
Trial end
2022-05-10
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Nifedipine 30MG
Placebos
At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.
Arms:
Placebo
Size
110
Primary endpoint
Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo
Between enrollment and delivery, assessed up to 18 weeks
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients are enrolled and randomly selected to receive Nifedipine or placebo through delivery of her infant.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ACTUAL'}}
Updated at
2023-07-24

1 organization

2 products

1 indication

Organization
Ohio State University
Product
Nifedipine
Indication
Preeclampsia Severe
Product
Placebos