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Completed

NCT Number: NCT04392375

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebos

Drug

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

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

    Time frame: Between enrollment and delivery, assessed up to 18 weeks

    Measured acute antihypertension therapy between enrollment and delivery

Secondary outcomes

  1. Number of Participants Stratified by Route of Delivery

    Time frame: At delivery

  2. Number of Participants With Various Indications for Cesarean Delivery

    Time frame: Between enrollment and delivery, assessed up to 18 weeks

    Some participants could have more than one indication for Cesarean Delivery.

  3. 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

  4. Number of Participants Who Required Acute Antihypertension Treatments Postpartum

    Time frame: At delivery

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 18, 2020
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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