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

Not Applicable

• Conditions: Miscarriage
• Interventions: Drug: vaginal misoprostol; Drug: sublingual misoprostol

• Registration Number: NCT05088707
• Lead Sponsor: Aswan University Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-10
• Study First Submitted QC: 2021-10-10
• Last Update Submitted: 2021-10-10
• Study First Posted: 2021-10-22
• Last Update Posted: 2021-10-22
• Study Start: 2021-11-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

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

Inclusion Criteria

• All women above 18 years of age
• between 13-26 weeks of gestation.
• Pregnancy is confirmed by a pregnancy test or ultrasound scan.
• missed abortion
• Normal general and gynecological examination.

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 the presentation.
• Known allergy to misoprostol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vaginal misoprostol	vaginal misoprostol	All patients will receive three doses of vaginal misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home. Paracetamol, eight hourly, will be provided as analgesic or antipyretic
sublingual misoprostol	sublingual misoprostol	All patients will receive three doses of sublingual misoprostol every four hours. The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home. Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception

Primary Outcome Measures

Name	Time	Method
Completeness of abortion	7 days	expulsion of Products of conception by visual inspection

Secondary Outcome Measures

Name	Time	Method
Successful medical abortion	7 days	cervical os is closed with endometrial thickness of less than 15 mm
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

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt