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

NCT05088707 | Unknown DMC

• 1 other identifier: aswu/354/3/18
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Miscarriage

Keywords

miscarriage; sublingual; vaginal; misoprostol

Outcome Measures

Primary Outcomes (1)

• Completeness of abortion

  expulsion of Products of conception by visual inspection

  7 days

Secondary Outcomes (2)

• Successful medical abortion

  7 days

• Bleeding pattern following treatment

  7 days

Study Arms (2)

sublingual misoprostol

EXPERIMENTAL

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

Drug: sublingual misoprostol

vaginal misoprostol

ACTIVE COMPARATOR

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

Drug: vaginal misoprostol

Interventions

sublingual misoprostol DRUG

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 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 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

Also known as: experimental

sublingual misoprostol

vaginal misoprostol DRUG

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

Also known as: Active Comparator

vaginal misoprostol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnant women with second missed abortion
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Hany F Sallam, md

CONTACT

+201112505221; hanysallam876@yahoo.com

nahla w Shady, md

CONTACT

+201022336052; hanygyne@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: an open-label randomized controlled study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Professor

Model Details: an open-label randomized controlled study

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: October 22, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)