Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion
1 other identifier
interventional
288
0 countries
N/A
Brief Summary
Efficacy of sublingual versus vaginal misoprostol in termination of first trimester missed abortion
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2021
Shorter than P25 for early_phase_1
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
August 2, 2021
CompletedStudy Start
First participant enrolled
August 3, 2021
CompletedFirst Posted
Study publicly available on registry
August 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2021
CompletedAugust 11, 2021
August 1, 2021
2 months
August 2, 2021
August 6, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
The occurance of complete abortion within 24 hours with Misoprostol drug
Efficacy of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion
Within 24 hours
Which route is the best and less side effects in complete termination of first trimester missed abortion by Misoprostol drug
Vaginal versus sublingual route of administration of Misoprostol for complete termination of first trimester missed abortion
within 24 hours
Study Arms (2)
Sublingual Misoprostol for termination of first trimester missed abortion
ACTIVE COMPARATORPatients diagnosed as first trimester missed abortion will receive sublingual Misoprostol 800 micrograms every 4 hours up to five doses
Vaginal Misoprostol for termination of first trimester missed abortion
ACTIVE COMPARATORPatients diagnosed as first trimester missed abortion will receive vaginal Misoprostol 800 micrograms every 4 hours up to five doses
Interventions
sublingual versus vaginal Misoprostol in termination of first trimester missed abortion
Eligibility Criteria
You may qualify if:
- Women with an ultrasound diagnosis of missed abortion \< 13 weeks gestation without any clinical criteria of Inevitable abortion.
You may not qualify if:
- Patients refused the medical treatment.
- Patients have contraindications of the drug (Misoprostol).
- Missed abortion associated with any signs of sepsis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (2)
Allameh Z, Goharian M, Eslamian M. Effect of misoprostol with and without letrozole on the induction of abortion for women with first-trimester missed abortion. Int J Gynaecol Obstet. 2020 Nov;151(2):214-218. doi: 10.1002/ijgo.13326. Epub 2020 Sep 1.
PMID: 32700359BACKGROUNDTang OS, Gemzell-Danielsson K, Ho PC. Misoprostol: pharmacokinetic profiles, effects on the uterus and side-effects. Int J Gynaecol Obstet. 2007 Dec;99 Suppl 2:S160-7. doi: 10.1016/j.ijgo.2007.09.004. Epub 2007 Oct 26.
PMID: 17963768BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident in obstetrics and gynecology
Study Record Dates
First Submitted
August 2, 2021
First Posted
August 11, 2021
Study Start
August 3, 2021
Primary Completion
October 15, 2021
Study Completion
October 16, 2021
Last Updated
August 11, 2021
Record last verified: 2021-08