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

Phase 4

Completed

• Conditions: Preeclampsia Severe
• Interventions: Drug: Nifedipine 30 MG; Drug: Placebos

• Registration Number: NCT04392375
• Lead Sponsor: Ohio State University

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 preeclampsia with severe features.

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 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.

Study Timeline

• Study First Submitted: 2020-05-02
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-18
• Study Start: 2020-06-09
• Primary Completion: 2022-04-20
• Study Completion: 2022-05-10
• Results First Submitted: 2023-05-18
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-06
• Last Update Submitted: 2023-07-06
• Results First Posted: 2023-07-24
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nifedipine 30MG	Nifedipine 30 MG	Oral administration of 30mg Nifedipine XL q24 hours until delivery
Placebo	Placebos	Matching placebo group q24hrs until delivery

Primary Outcome Measures

Name	Time	Method
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	Measured acute antihypertension therapy between enrollment and delivery

Secondary Outcome Measures

Name	Time	Method
Number of Participants Stratified by Route of Delivery	At delivery
Number of Participants With Various Indications for Cesarean Delivery	Between enrollment and delivery, assessed up to 18 weeks	Some participants could have more than one indication for Cesarean Delivery.
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

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine; 🇺🇸 Columbus, Ohio, United States