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临床试验/NCT05147857
NCT05147857Unknown不适用

Dilapan Versus Prostaglandin E1 in Induction of Midtrimester Abortion

Ain Shams Maternity Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1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
入组人数
60
试验地点
1
主要终点
Abortion

研究概览

简要总结

This study is done aiming to find out an effective method to induce second trimester abortion within a reasonable time and with the least possible cost and complications.

详细描述

od complete history taking and examination will be performed including measurement of blood pressure, pulse and temperature. Skin was examined for petichae or ecchymosis to exclude coagulation defects or blood diseases. The abdominal examination included detection of the size of the uterus (in cm above symphysis pubis), presence of scar of previous laparotomy, tenderness or rigidity. The local examination included detection of uterine size by bimanual examination, cervical dilatation, consistency, effacement, and position.

Each patient was investigated for hemoglobin content, Rh-typing, blood sugar level, Coagulation profile, renal function tests, and liver function tests.

Our patients were divided into 2 groups, each containing-- patients: In the First group, induction of abortion was carried out by prostaglandin E1 methyl analogue, Misoprestol. It was given by vaginal routeIn the second group, induction of abortion will be started with Dilapan.s followed by surgical evacuation In the First group, the initial Bishop score will be recorded and the minimal dose of one tablet was inserted deep in the posterior fornix. The dose will be repeated every 4 hours till the products of conception are expelled. If remnants of conception are retained for more than 30 minutes, oxytocin drip will be initiated starting with a minimal dose of 2.5 U in 500-ml glucose 5%. Failure of induction was considered if uterine contractions and start of expulsion had not occurred within 36 hours from initiation of therapy.

In the second group, The vagina will be prepared with Povidine iodine as an antiseptic, which is also used to moisten the dilators. A sterile speculum will be inserted and after inspection of the cervix, the anterior lip will stabilized with ring forceps. Using gentle traction on the cervix, the Dilapan dilator will be inserted into the cervical canal, the upper vagina will then packed with a sterile gauze to maintain the dilator in place. The dilators were left for a period not less than 6 and not more than 24 hours. After removal of the gauze, the Dilapan handle will be grasped with forceps and removed with gentle steady downward traction on Dialpan loop itself. The cervical dilatation will be measured by Hegar's dilators and recorded. Surgical evacuation will then carried out under general anesthesia. In cases with gestational age more than 16 weeks, an oxytocin infusion will be MasterDegreeThesis/MFA/ISRO/FacultyOfMedicine/ASU Page 4

added to induce uterine contractions and expulsion of the contents. Failure was considered if dilatation of the cervix was not achieved, or if there was no response to oxytocin within 36 hours.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Sure indication of abortion.
  • Estimated gestational age between 12-24 weeks as calculated from last normal menstrual period (LNMP) and confirmed by abdominal ultrasound.
  • Intact membranes.
  • No medical disorder prevents the usage of any of the medications in the study.

排除标准

  • History of cervical surgery or presence of cervical scarring.

研究组 & 干预措施

Mesotac in mid trimester

Active Comparator

Prostaglandin

干预措施: Misoprostol (Drug)

Dilapan s in mid trimester

Active Comparator

is an osmotic hygroscopic dilator produced from a patented Aquacryl® hydrogel that guarantees consistency of action.

It is a rigid gel rod that increases in volume by absorbing fluids from the cervical canal, so it gradually dilates the cervix The thin 4 mm rod can expand up to 15 mm over a 12-24 hours period. This allows it to dilate and soften the cervix gradually.

干预措施: Dilapan s (Device)

结局指标

主要结局

Abortion

时间窗: 24 hour from procedure

Abortion time in days

次要结局

  • Hospital stay(24 hour from admission)

研究者

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

Reem Nasr Abd el hafez Nasr

Principal investigator

Ain Shams Maternity Hospital

研究点 (1)

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