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临床试验/NCT06818903
NCT06818903尚未招募不适用

Misoprostol Versus Intracervical Foley's Catheter for Termination of Second Trimester Abortion

Assiut University0 个研究点目标入组 122 人开始时间: 2025年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
122
主要终点
Interval time

研究概览

简要总结

In this study we compare between the effectiveness of combined Foley's catheter with Misoprostol and intracervical Foley's catheter alone for termination of second trimester abortion.

详细描述

Termination of pregnancy (TOP) is defined as elective expulsion or extraction of products of conception from uterus instead of spontaneous onset of process irrespectable of duration of pregnancy. Worldwide mid-trimester abortion constitutes 10-15% of all induced abortions but responsible for two-thirds of all major complications Despite the recent advances in prenatal diagnosis in first trimester. Termination of pregnancy in second trimester due to foetal abnormalities and intrauterine foetal death still accounts for large number of abortions, and has increased the demand for rapid termination of pregnancy. In intrauterine fetal death in 2nd trimester, expulsion may take several weeks. This is associated with psychological trauma, coagulopathy and intrauterine infection. Among various methods of second trimester termination, evacuation and curettage induces risk of bleeding, infection, uterine perforation and cervical trauma. The introduction of misoprostol , a synthetic prostaglandin E1 analogue (PGE1) has become an important for cervical ripening and uterotonic action. It is economic, stable at room temperature and is associated with few side effects such as fever, vomiting and diarrhea. There is still debate about doses, routes and regimes of PGE1 for termination of pregnancy during 2nd trimester. It is active orally but more effective and better tolerated when administrated vaginally and has fewer side effects. Vaginal route is preferred in first and second trimester. The use of Foley's catheter has been recommended in many developing countries. The reports from different countries have mentioned excellent results with the use of Foley's catheter either alone or in combination with prostaglandins. The scope of our study: is to compare the use of Foley's catheter combination with Misoprostol versus Foley's catheter alone for pre induction cervical ripening and induction of second trimester abortion.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged between 18 - 40 years of age with mid-trimester fetal death inutero.
  • Singleton pregnancies from 18-24 weeks.
  • women with unfavourable cervix (Bishop Score < 5) at the time of recruitment.
  • Previous one CS and non-previous CS pregnant women.

排除标准

  • • Previous 2 CS or more.
  • Medical contraindications for prostaglandin therapy (allergy to prostaglandins or severe asthma).
  • co-morbidities like severe anemia (Hb < 7g/dl), hypertension, diabetes, or coagulopathy .
  • Women with excessive vaginal discharge or rupture of membrane.
  • Women having any complication in previous caesarean like endometritis, reopening, scar dehiscence etc.
  • Active genital infection e. g. active genital Herpes simplex infection.

研究组 & 干预措施

Misopristol

women will be subjected to Foley catheter balloon insertion. A 16F Foley catheter will be inserted into the cervix and inflated with 40 ml of saline and it will be pulled out to ensure the balloon covered the internal os. The catheter will be fixed to the inner thigh with light traction .The Foley catheter balloon will be checked every 4 hours.

干预措施: Misopristol (Drug)

Foley catheter

women will be subjected to Foley catheter balloon insertion. A 16F Foley catheter will be inserted into the cervix and inflated with 40 ml of saline and it will be pulled out to ensure the balloon covered the internal os. The catheter will be fixed to the inner thigh with light traction .The Foley catheter balloon will be checked every 4 hours. Women will be received, according to department policy,,At the same sitting 400μg misoprostol kept in posterior fornix and the dose will be repeated every three hours till the catheter got expelled out or till maximum five doses

干预措施: Foley catheter (Device)

结局指标

主要结局

Interval time

时间窗: periprocedurally

the interval (hours) between Foley catheter balloon insertion to complete abortion

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Kamel Ali

Resident

Assiut University

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