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

NCT04392375 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2019H0431
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia Severe

Keywords

preeclampsia severe, Nifedipine 30MG, placebo controlled

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

Study Arms (2)

Nifedipine 30MG

ACTIVE COMPARATOR

Oral administration of 30mg Nifedipine XL q24 hours until delivery

Drug: Nifedipine 30 MG

Placebo

PLACEBO COMPARATOR

Matching placebo group q24hrs until delivery

Drug: Placebos

Interventions

Nifedipine 30 MG DRUG

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.

Nifedipine 30MG

Placebos DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 36189646 DERIVED

MeSH Terms

Interventions

Nifedipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kara Rood, MD
• Organization: The Ohio State University

Kara.Rood@osumc.edu

440-321-0264

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Model Details: Patients are enrolled and randomly selected to receive Nifedipine or placebo through delivery of her infant.

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 18, 2020
• Study Start: June 9, 2020
• Primary Completion: April 20, 2022
• Study Completion: May 10, 2022
• Last Updated: July 24, 2023
• Results First Posted: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)