Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Prolongation of pregnancy
研究概览
简要总结
The objective of our study is to determine the clinical utility related to the maintenance oral nifedipine therapy in patients with symptomatic placenta previa. This study is a prospective, randomized controlled trial with the inclusion, after 24 weeks gestation, of hospitalized patients with symptomatic placenta praevia. All patients may initially receive oral nifedipine therapy with steroid prophylaxis for 48 hours. After then, patients are randomly assigned to receive either oral nifedipine (20 mg every 8 hours) or placebo (one every 8 hours) until 37 weeks of gestation.
The primary outcome for the trial is the length of pregnancy in days after the enrollment. A sample size calculation is designed to detect at least a 14 -day difference in time gained in patients with maintenance oral nifedipine therapy. A sample size of about 52 patients per group would have a 80 % chance of detecting this difference at the 5 % level of significance.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasonography
- •Placenta previa may be symptomatic with at least one episode of bleeding
- •Estimated gestational age within 24 to 34 weeks
- •Maternal age > 18 years
- •Informed consent after received an explanation of the study and an information sheet
- •Social affiliation
排除标准
- •Premature rupture of membranes
- •Severe bleeding requiring an immediate termination of pregnancy
- •Abnormal fetal heart rates requiring an immediate termination of pregnancy
- •Intrauterine fetal death
- •Pre-eclampsia, chorioamnionitis, liver disease, severe chronic renal disease, heart disease
- •Abruptio placentae
- •Nifedipine sensibility
- •Drugs interaction with nifedipine
研究组 & 干预措施
A
Placebo three times daily
干预措施: Placebo (Drug)
B
20 mg of slow-release Nifedipine three times daily
干预措施: Nifedipine (Drug)
结局指标
主要结局
Prolongation of pregnancy
时间窗: From allocation to the delivery
次要结局
- Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required(At the end of the study)