EUCTR2022-002480-30-IT招募中1 期
PeRinatal Outcomes with ACTive versus expectant management of women with Pre-labor Rupture Of Membranes: a phase III, open-label, randomized controlled multicentric trial - PROACT PROM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Gestational age = 37 weeks
- •2. Negative rectovaginal GBS swab
- •3. Absent/poor uterine contractile activity 6 h after PROM (0-2 contractions /10 min)
- •4. Cephalic presentation
- •5. Age =18 years of age at the time of randomization
- •6. Ability to provide an informed consent
- •7. Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1400
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prematurity (<37 weeks)
- •2. GBS positive vagino-rectal swab or with an unknown swab
- •3. Multiple pregnancies
- •4. Previous cesarean section (CS)
- •5. Breech presentation, transverse lie or other indication for elective CS
- •6. Suspected clinic for intra-amniotic infection
- •7. Stained amniotic fluid
- •8. Alterations of the FHR
- •9. Unknown exact ROM time
研究者
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