Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06818903

Misoprostol in Missed Abortion

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • • 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.

Treatment and study plan

Misopristol

Drug

Foley catheter with Misopristol local application

Other names: Foley catheter

foley catheter

Device

Foley catheter alone

Primary outcomes

  1. Interval time

    Time frame: periprocedurally

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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.