Status:
COMPLETED
Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor
Lead Sponsor:
Ohio State University
Conditions:
Preeclampsia Severe
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04392375
Start Date
June 9 2020
End Date
May 10 2022
Last Update
July 24 2023
Active Locations (1)
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1
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210