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

Preeclampsia Severe Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392375
• Other study ID #: 2019H0431
• Status: Completed
• Phase: Phase 4
• Start date: June 9, 2020
• Est. completion date: May 10, 2022

Study information

• Verified date: July 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 10, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia Severe

Intervention

Drug:
• 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.
• Placebos
At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Stratified by Route of Delivery		At delivery
Secondary	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
Secondary	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
Secondary	Number of Participants Who Required Acute Antihypertension Treatments Postpartum		At delivery