Overview

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

Status:
Recruiting

Trial end date:
2022-12-01

Target enrollment:
0

Participant gender:
Female

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 preeclampsia with severe features.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Ohio State University

Treatments:

Nifedipine

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