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Misoprostol in Missed Abortion

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06818903
Enrollment
122
Registered
2025-02-11
Start date
2025-03-01
Completion date
2027-05-01
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abortion; Attempted

Keywords

Abortion, Misopristol, Foley catheter

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.

Interventions

Foley catheter with Misopristol local application

DEVICEFoley catheter

Foley catheter alone

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Interval timeperiprocedurallythe interval (hours) between Foley catheter balloon insertion to complete abortion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026