Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
Study NCT ID:
NCT06818903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-11
First Post:
2025-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Misoprostol in Missed Abortion
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Misoprostol Versus Intracervical Foley's Catheter for Termination of Second Trimester Abortion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: