Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Nifedipine 30MG
Oral administration of 30mg Nifedipine XL q24 hours until delivery
干预措施: Nifedipine 30 MG (Drug)
Placebo
Matching placebo group q24hrs until delivery
干预措施: Placebos (Drug)
结局指标
主要结局
Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo
时间窗: Between enrollment and delivery, assessed up to 18 weeks
Measured acute antihypertension therapy between enrollment and delivery
次要结局
- Number of Participants Stratified by Route of Delivery(At delivery)
- Number of Participants With Various Indications for Cesarean Delivery(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(Between enrollment and delivery, assessed up to 18 weeks)
- Number of Participants Who Required Acute Antihypertension Treatments Postpartum(At delivery)
研究者
Kara M Rood, MD
MD, Assistant Professor
Ohio State University