Misoprostol in Missed Abortion

NCT ID: NCT06818903

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-05-01

Brief Summary

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.

Detailed Description

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.

Conditions

Abortion; Attempted

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Misopristol

Intervention Type: DRUG

Foley catheter with Misopristol local application

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

Foley catheter

Intervention Type: DEVICE

Foley catheter alone

Interventions

Misopristol

Foley catheter with Misopristol local application

Intervention Type: DRUG

Foley catheter

Foley catheter alone

Intervention Type: DEVICE

Other Intervention Names

Foley catheter

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ali Kamel Ali

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

A456743

Identifier Type: -

Identifier Source: org_study_id