Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage

Phase 3

Completed

• Conditions: Missed Abortion
• Interventions: Drug: vaginal misoprostol; Drug: sublingual misoprostol

• Registration Number: NCT02686840
• Lead Sponsor: Ain Shams University

Brief Summary

The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

Detailed Description

In women with first trimetric-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-22
• Primary Completion: 2017-01
• Study Completion: 2017-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-13
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• All women above 18 years of age
• Less than 12 weeks of gestation.
• Pregnancy is confirmed by pregnancy test or ultrasound scan.
• missed abortion
• Normal general and gynecological examination.
• The size of the uterus on pelvic examination was compatible with the estimated duration of pregnancy

Exclusion Criteria

• Hemodynamically unstable.
• Suspected sepsis with temperature 38 °C.
• Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism, respiratory illnesses, recent liver disease or pruritus of pregnancy.
• Presence of intrauterine contraceptive device (IUCD).
• Suspect or proven ectopic pregnancy.
• Failed medical or surgical evacuation before presentation.
• Known allergy to misoprostol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vaginal misoprostol	vaginal misoprostol	Group B (100 patients): will be treated with vaginal misoprostol
sublingual misoprostol	sublingual misoprostol	Group A (100 patients): will be treated with sublingual misoprostol

Primary Outcome Measures

Name	Time	Method
Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection	7 days

Secondary Outcome Measures

Name	Time	Method
Successful medical abortion: cervical os is closed with endometrial thickness of less than 15 mm	7 days
Failure: endometrial thickness of more than 15 mm on day seven (from third dose of misoprostol) or developing of complications before day seven needing early surgical evacuation.	7 days
Pain resulting from the procedure	7 days	this will be assessed by the doses of paracetamol given in mg
Bleeding pattern following treatment	7 days	This will be assessed by hemoglobin(g/dl) and haematocrit level after the treatment , if the patients required blood transfusion and number of units transfused and number of days of bleeding
Additional uterotonic used	7 days	additional misoprostol doses in mcg

Trial Locations

Locations (1)

Ain shams university maternity hospital; 🇪🇬 Cairo, Egypt