Phase 4
N=110
Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor
Preeclampsia Severe
Bottom Line
View on ClinicalTrials.gov: NCT04392375 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo — 18; 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nifedipine 30 MG (Drug); Placebos (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ohio State University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo |
18; 27 | — |
| SECONDARY Number of Participants Stratified by Route of Delivery |
11; 17; 42; 32 | — |
| SECONDARY Number of Participants With Various Indications for Cesarean Delivery |
8; 6; 1; 5; 3; 7 | — |
| SECONDARY Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy |
8; 6 | — |
| SECONDARY Number of Participants Who Required Acute Antihypertension Treatments Postpartum |
20; 19 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04392375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.