Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion

Early Phase 1

• Conditions: Missed Abortion
• Interventions: Drug: Misoprostol Pill

• Registration Number: NCT05001061
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-02
• Study Start: 2021-08-03
• Study First Submitted QC: 2021-08-06
• Last Update Submitted: 2021-08-06
• Study First Posted: 2021-08-11
• Last Update Posted: 2021-08-11
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 288

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sublingual Misoprostol for termination of first trimester missed abortion	Misoprostol Pill	Patients 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	Misoprostol Pill	Patients diagnosed as first trimester missed abortion will receive vaginal Misoprostol 800 micrograms every 4 hours up to five doses

Primary Outcome Measures

Name	Time	Method
The occurance of complete abortion within 24 hours with Misoprostol drug	Within 24 hours	Efficacy of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion
Which route is the best and less side effects in complete termination of first trimester missed abortion by Misoprostol drug	within 24 hours	Vaginal versus sublingual route of administration of Misoprostol for complete termination of first trimester missed abortion