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临床试验/NCT02635412
NCT02635412撤回不适用

Delivery Timing in Morbidly Adherent Placentas: a Randomized, Controlled Trial

The University of Texas Health Science Center, Houston0 个研究点开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Composite neonatal morbidity

研究概览

简要总结

This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta.

详细描述

This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta dispositioned for a scheduled delivery. The primary outcome will be assessed by comparing the composite neonatal morbidity and composite maternal morbidity between the two groups (delivery at 34 versus 36 weeks gestational age).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with monographically morbidly adherent placenta with or without a placenta previa.
  • Scheduled delivery via cesarean hysterectomy

排除标准

  • Delivery planned prior to 36 weeks (e.g. non-reassuring fetal status, preterm labor, severe preeclampsia, other medical/fetal indication for delivery as determined by the managing physician).

研究组 & 干预措施

Scheduled delivery at 34 weeks

Placebo Comparator

Scheduled delivery at 34 weeks (range 33 weeks 5 days to 34 weeks 3 days)

干预措施: Scheduled timing of delivery (Other)

Scheduled delivery at 36 weeks

Active Comparator

Scheduled delivery at 36 weeks (range 35 weeks 5 days to 36 weeks 3 days)

干预措施: Scheduled timing of delivery (Other)

结局指标

主要结局

Composite neonatal morbidity

时间窗: Within 72 hours of newborn discharge

Maternal neonatal morbidity

时间窗: Within 72 hours of patient discharge

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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