NCT01127581已完成3 期
Phase III, Double-blind, Randomized, Multicenter Study of Exogenous Prostaglandin Comparing the Efficacy & Safety of the MVI 200 mcg Versus the Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery in Pregnant Women at Term
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,358
- 试验地点
- 34
- 主要终点
- Time to Vaginal Delivery During the First Hospital Admission
研究概览
简要总结
The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200 microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and induction of labor.
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
- •Provide written informed consent;
- •Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
- •Women aged 18 years or older;
- •Candidate for pharmacological induction of labor;
- •Single, live vertex fetus;
- •Baseline modified Bishop score ≤ 4;
- •Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
- •Body Mass Index (BMI) ≤ 50 at the time of entry to the study.
排除标准
- •Women in active labor;
- •Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
- •Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
- •Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
- •Fetal malpresentation;
- •Diagnosed congenital anomalies, not including polydactyly;
- •Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
- •Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;
- •Ruptured membranes ≥ 48 hours prior to the start of treatment;
- •Suspected chorioamnionitis;
- •Fever (oral or aural temperature > 37.5°C);
- •Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
- •Known or suspected allergy to misoprostol, dinoprostone, other prostaglandins or any of the excipients;
- •Any condition urgently requiring delivery;
- •Unable to comply with the protocol.
研究组 & 干预措施
MVI 200
Experimental
MVI 200 mcg vaginal insert
干预措施: MVI 200 (Drug)
Dinoprostone Vaginal Insert (DVI)
Active Comparator
10 mg Dinoprostone vaginal insert
干预措施: Dinoprostone Vaginal Insert (DVI) (Drug)
结局指标
主要结局
Time to Vaginal Delivery During the First Hospital Admission
时间窗: Interval from study drug administration to vaginal delivery (average 24 hours)
Incidence of Cesarean Delivery During the First Hospital Admission
时间窗: Interval from study drug administration to cesarean delivery (average 24 hours)
次要结局
- Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission(Interval from study drug administration to neonate delivery (average 24 hours))
- Time to Active Labor During the First Hospital Admission(Interval from study drug administration to active labor (average 12 hours))
- Incidence of Pre-delivery Oxytocin During the First Hospital Admission(At least 30 minutes after study drug removal)
- Incidence of Vaginal Delivery Within 12 Hours(Interval from study drug administration to vaginal delivery within 12 hours)
- Incidence of Any Delivery Within 24 Hours(Interval from study drug administration to delivery of neonate within 24 hours)
- Incidence of Any Delivery Within 12 Hours(Interval from study drug administration to delivery of neonate within 12 hours)
- Incidence of Vaginal Delivery Within 24 Hours(Interval from study drug administration to vaginal delivery within 24 hours)
- Incidence of Vaginal Delivery(Interval from study drug administration to vaginal delivery (average 24 hours))
- Rate of Adverse Events(From study drug administration to hospital discharge (approximately 48-72 hours))
研究者
研究点 (34)
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