A Multi-center, Randomized, Double-blind Phase III Study of the Efficacy and Safety of the Misoprostol Vaginal Insert Compared to Cervidil for Women Requiring Cervical Ripening and Induction of Labor (The MVP Study).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,308
- 试验地点
- 52
- 主要终点
- Minutes From Drug Insertion to Vaginal Delivery
研究概览
简要总结
The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.
详细描述
Induction of labor is required in approximately 20% of pregnant women. Although contractions can be brought on by oxytocin ("pitocin"), some women need help in softening the cervix, or mouth of the womb (uterus), before oxytocin can be started. Prostaglandins have been shown to ripen, or soften, the cervix; at present, the only prostaglandin approved for marketing by FDA for this purpose is dinoprostone. Dinoprostone can be delivered in several ways; one method is to use a polymer vaginal insert that slowly releases the dinoprostone directly to the cervical tissues. This product is called Cervidil (R) and has been marketed for more than 10 years in the United States. Misoprostol is another form of prostaglandin that is approved for protecting the stomach and intestinal lining for patients taking NSAIDs. Misoprostol has also been used by many obstetricians for cervical ripening and inducing contractions, but, it is not approved by FDA for this purpose.
The same company that makes the Cervidil polymer insert has made an insert that will slowly release misoprostol. This study will determine whether this investigational insert containing misoprostol will decrease time to vaginal delivery compared to Cervidil. Two different doses of misoprostol will be tested (50 micrograms and 100 micrograms); each vaginal insert will gradually release a small, controlled amount of misoprostol over up to 24 hours.
Comparator: The Cervidil (R) vaginal insert containing dinoprostone will be the comparator in this study.
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
- •Pregnant women at least 36 weeks gestation requiring cervical ripening and induction of labor
排除标准
- •No uterine scar (no previous delivery by cesarean section)
- •No multiple gestation
- •No condition that disallows use of prostaglandins for induction of labor
- •No more than 3 previous vaginal births beyond 24 weeks gestation
研究组 & 干预措施
MVI 100
Misoprostol vaginal insert 100 mcg over 24h
干预措施: Misoprostol vaginal insert 100 mcg (Drug)
MVI 50
Misoprostol vaginal insert 50 mcg over 24h
干预措施: Misoprostol vaginal insert 50 mcg (Drug)
Cervidil 10 mg vaginal insert
Cervidil 10 mg over 24h
干预措施: Dinoprostone vaginal insert (Cervidil) (Drug)
结局指标
主要结局
Minutes From Drug Insertion to Vaginal Delivery
时间窗: 2880 minutes
Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered.
Percentage of Participants With a Cesarean Section Delivery
时间窗: 2880 minutes
Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days.
次要结局
- Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events(96 hours)
- Percentage of Participants With Pre-Delivery Oxytocin Use(2880 minutes)
- Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert(12 hours)
- Minutes to Onset of Active Labor(2880 minutes)
- Minutes to Rupture of Membranes (ROM)(2880 minutes)
- Duration of Stay in Minutes in Labor and Delivery Suite(5760 minuts)
- Days in Hospital for Mother and Neonate(10 days)