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

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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia Severe
• Intervention / Treatment: Drug: Nifedipine 30 MG; Drug: Placebos

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nifedipine 30MG; Oral administration of 30mg Nifedipine XL q24 hours until delivery	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.
Placebo Comparator: Placebo; Matching placebo group q24hrs until delivery	Drug: Placebos; At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Stratified by Route of Delivery		At delivery
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
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

Collaborators and Investigators

• Sponsor: Ohio State University

Publications and helpful links

General Publications

• Cleary EM, Racchi NW, Patton KG, Kudrimoti M, Costantine MM, Rood KM. Trial of Intrapartum Extended-Release Nifedipine to Prevent Severe Hypertension Among Pregnant Individuals With Preeclampsia With Severe Features. Hypertension. 2023 Feb;80(2):335-342. doi: 10.1161/HYPERTENSIONAHA.122.19751. Epub 2022 Oct 3.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2020
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): May 10, 2022

Study Registration Dates

• First Submitted: May 2, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: preeclampsia severe, Nifedipine 30MG, placebo controlled
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Nifedipine
• Other Study ID Numbers: 2019H0431

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No