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

The Ohio State University

Status and phase: Completed; Phase 4

Conditions: Preeclampsia Severe

Treatments: Drug: Placebos; Drug: Nifedipine 30 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04392375

2019H0431

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

110 participants in 2 patient groups, including a placebo group

Nifedipine 30MG

Active Comparator group

Description:

Oral administration of 30mg Nifedipine XL q24 hours until delivery

Treatment:

Drug: Nifedipine 30 MG

Placebo

Placebo Comparator group

Description:

Matching placebo group q24hrs until delivery

Treatment:

Drug: Placebos