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

Primary Purpose

Preeclampsia Severe

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nifedipine 30 MG
Placebos
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preeclampsia Severe focused on measuring preeclampsia severe, Nifedipine 30MG, placebo controlled

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nifedipine 30MG

Placebo

Arm Description

Oral administration of 30mg Nifedipine XL q24 hours until delivery

Matching placebo group q24hrs until delivery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants Stratified by Route of Delivery
Number of Participants With Various Indications for Cesarean Delivery
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
Number of Participants Who Required Acute Antihypertension Treatments Postpartum

Full Information

First Posted
May 2, 2020
Last Updated
July 6, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT04392375
Brief Title
Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor
Official Title
Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia Severe
Keywords
preeclampsia severe, Nifedipine 30MG, placebo controlled

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients are enrolled and randomly selected to receive Nifedipine or placebo through delivery of her infant.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nifedipine 30MG
Arm Type
Active Comparator
Arm Description
Oral administration of 30mg Nifedipine XL q24 hours until delivery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo group q24hrs until delivery
Intervention Type
Drug
Intervention Name(s)
Nifedipine 30 MG
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.
Primary Outcome Measure Information:
Title
Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo
Description
Measured acute antihypertension therapy between enrollment and delivery
Time Frame
Between enrollment and delivery, assessed up to 18 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Stratified by Route of Delivery
Time Frame
At delivery
Title
Number of Participants With Various Indications for Cesarean Delivery
Description
Some participants could have more than one indication for Cesarean Delivery.
Time Frame
Between enrollment and delivery, assessed up to 18 weeks
Title
Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy
Time Frame
Between enrollment and delivery, assessed up to 18 weeks
Title
Number of Participants Who Required Acute Antihypertension Treatments Postpartum
Time Frame
At delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36189646
Citation
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.
Results Reference
derived

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

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