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NCT05001061 Clinical Trial

Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion

Missed Abortion Clinical Trial

Official title:
Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05001061
Other study ID # Misoprostol abortion
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date August 3, 2021
Est. completion date October 16, 2021

Study information
Verified date August 2021
Source Cairo University
Contact Ahmed Emam
Phone 01003304781
Email emam3882@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Efficacy of sublingual versus vaginal misoprostol in termination of first trimester missed abortion

Description:

study will be made on female patients with first trimester missed abortion confirmed by ultrasound . Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol and the other group(B) will receive vaginal Misoprostol as a 800 micro grams every 4 hours in both groups up to five doses the aim of the study is to compare efficay of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion and which route is the best will less side effects.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 288
Est. completion date October 16, 2021
Est. primary completion date October 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Women with an ultrasound diagnosis of missed abortion < 13 weeks gestation without any clinical criteria of Inevitable abortion. Exclusion Criteria: - Patients refused the medical treatment. - Patients have contraindications of the drug (Misoprostol). - Missed abortion associated with any signs of sepsis

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Misoprostol Pill
sublingual versus vaginal Misoprostol in termination of first trimester missed abortion

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

References & 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. — View Citation

Tang 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. Epub 2007 Oct 26. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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Recruiting NCT03698734 - Evening Primrose Oil Efficacy in Second Trimester Abortion Phase 3
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Recruiting NCT03081104 - Operative Hysteroscopy and Ultrasound Guided Vacuum Aspiration Versus Blind Vacuum Aspiration for the Treatment of Missed Abortion N/A
Completed NCT00892229 - Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil Phase 2
Active, not recruiting NCT04981457 - Comparative Study Between Combined Vaginal Misoprostol Phase 1
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Recruiting NCT02573051 - Termination Of Anembryonic Pregnancy Phase 2
Not yet recruiting NCT04217265 - Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion Phase 4
Not yet recruiting NCT04215835 - Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage Phase 4
Recruiting NCT04705324 - Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion N/A
Completed NCT02686840 - Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage Phase 3
Terminated NCT02342002 - Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial Phase 4
Recruiting NCT01775917 - The Role of Uterine Artery Doppler Parameters in the Management of Retained Products of Conception. N/A