Clinical trial NCT04392375: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preeclampsia Severe
Keywords: preeclampsia severe, Nifedipine 30MG, placebo controlled
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are enrolled and randomly selected to receive Nifedipine or placebo through delivery of her infant.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo
timeFrame: Between enrollment and delivery, assessed up to 18 weeks
Secondary outcomes:
measure: Number of Participants Stratified by Route of Delivery
timeFrame: At delivery
measure: Number of Participants With Various Indications for Cesarean Delivery
timeFrame: Between enrollment and delivery, assessed up to 18 weeks
measure: Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy
timeFrame: Between enrollment and delivery, assessed up to 18 weeks
measure: Number of Participants Who Required Acute Antihypertension Treatments Postpartum
timeFrame: At delivery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
state: Ohio
Study officials:
References:
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.