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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
110
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.
At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States
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
Time frame: Between enrollment and delivery, assessed up to 18 weeks
Number of Participants Stratified by Route of Delivery
Time frame: At delivery
Number of Participants With Various Indications for Cesarean Delivery
Some participants could have more than one indication for Cesarean Delivery.
Time frame: 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
Time frame: Between enrollment and delivery, assessed up to 18 weeks
Number of Participants Who Required Acute Antihypertension Treatments Postpartum
Time frame: At delivery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.