Sequential Use of Foley Catheter With Amniotomy for Second-trimester Pregnancy Termination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The interval between induction to complete abortion
研究概览
简要总结
The termination of abortion is an important issue that has many controversies. The most common time of serious abortion-related complications is the second trimester. Missed abortion is one of the most common indications of termination of pregnancy in the second trimester. Misoprostol and mifepristone are effective drugs for induction of abortion but these drugs are now expensive, and non-available in many developing countries.
The effectiveness of Foley's catheter balloon on cervical ripping for mid-trimester pregnancy termination has been proved before. It can effectually shorten the time of the expulsion of the fetus. Amniotomy defines as an artificial rupture of the membranes; it is an ordinary obstetric practice used mainly in the induction of labor, with good results and less morbidity. The obstetricians used to combine amniotomy with other methods such as prostaglandins or oxytocin to induce labor in a woman with an unfavorable cervix.
Despite plenty of studies that investigated the role of amniotomy for induction of labor but the studies which addressed the role of amniotomy in the induction of second-trimester abortion are very scarce in the literature.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-40 years old.
- •Women who are pregnant in singleton mid-trimester missed abortion (18-26 weeks).
- •Bishop's score is ≤ 4.
排除标准
- •Women who delivered before by classic caesarian section or had a history of -myomectomy, hysteroscopic uterine surgery, or cervical surgery like conization.
- •Women with multiple gestations.
- •Women with ultrasonography evidence of low amniotic fluid volume.
- •Women with rupture of fetal membranes.
- •Women with evidence of low implanted placenta by ultrasound.
- •History or laboratory evidence of intra-uterine infection.
- •History is suggestive of latex allergy.
- •Women with severe anemia, hypertension, diabetes, or with coagulopathy.
研究组 & 干预措施
Amniotomy group
Amniotomy will be performed by toothed forceps. The handle of the device will be held with one hand outside the vagina while 2 fingers of the opposite hand will be placed in the vagina to guide the tip.
干预措施: Foley catheter balloon (Device)
Amniotomy group
Amniotomy will be performed by toothed forceps. The handle of the device will be held with one hand outside the vagina while 2 fingers of the opposite hand will be placed in the vagina to guide the tip.
干预措施: Amniotomy (Procedure)
Amniotomy group
Amniotomy will be performed by toothed forceps. The handle of the device will be held with one hand outside the vagina while 2 fingers of the opposite hand will be placed in the vagina to guide the tip.
干预措施: Oxytocin (Drug)
No-amniotomy group
No-amniotomy will be done
干预措施: Foley catheter balloon (Device)
No-amniotomy group
No-amniotomy will be done
干预措施: Oxytocin (Drug)
结局指标
主要结局
The interval between induction to complete abortion
时间窗: 15 hours
次要结局
未报告次要终点
研究者
Mohammed Khairy Ali
Assistant professor
Assiut University