NCT00787813已完成不适用
Effect of Oral N-Acetyl Cysteine on Pregnancy Outcome After Cervical Cerclage: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Gestational age at delivery
研究概览
简要总结
The aim of the study is to evaluate the effect of N-acetyl cysteine (NAC) on pregnancy outcome in women undergoing cervical cerclage for cervical insufficiency.
详细描述
A randomized controlled clinical trial to be carried out in a university-affiliated tertiary center.Participating women will be randomized into two groups: Group A will be given an oral daily dose of 0.6 g of NAC in effervescent form; group B, serving as controls, will not receive NAC.The two groups will then be compared according to pregnancy outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with history suggestive of cervical insufficiency together with ultrasound findings suggestive of cervical insufficiency undergoing elective cervical cerclage between the 11th and 12th gestational week.
- •singelton viable fetus
排除标准
- •women tested positive for bacterial vaginosis
- •women currently with threatened abortion (vaginal bleeding or uterinecramps)
- •age older than 35 years or younger than 20 years
- •unwillingness to participate
- •irregular and/or uncertain menstrual dates
- •rupture of membranes
- •previous cesarean delivery
- •possible risks for preterm birth in the current or previous pregnancy such as twin pregnancy, IUFD, malpresentation, known fetal anomaly, progesterone or heparin treatment during the current pregnancy, hypertension, and/or seizure disorders.
- •women with contra indications for cervical cerclage or anesthesia.
研究组 & 干预措施
1
Active Comparator
N-Acetyl Cysteine
干预措施: N-Acetyl Cysteine (Drug)
2
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Gestational age at delivery
时间窗: 3-6 months
次要结局
- Take home babies, neonatal morbidity(3-6 months)
研究者
研究点 (1)
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