Misoprostol in Missed Abortion
Misoprostol Versus Intracervical Foley's Catheter for Termination of Second Trimester Abortion
1 other identifier
observational
122
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2025
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
February 11, 2025
February 1, 2025
2 years
February 5, 2025
February 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Interval time
the interval (hours) between Foley catheter balloon insertion to complete abortion
periprocedurally
Study Arms (2)
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.
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
Interventions
Foley catheter with Misopristol local application
Eligibility Criteria
Women who are indicated for termination of pregnancy in second trimester due to fetal abnormalities and intrauterine fetal death
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
February 5, 2025
First Posted
February 11, 2025
Study Start
March 1, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
February 11, 2025
Record last verified: 2025-02