Sublingual Misoprostol In Medical Treatment of First Trimester Missed Miscarriage

NCT05103098 | Unknown DMC

• 1 other identifier: aswu/354/9/19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this work is to compare the effectiveness of sublingual misoprostol 400 mcg versus 800 mcg for medical treatment of the first trimester missed miscarriage.

Conditions

Miscarriage

Keywords

miscarriage; sublingual; misoprostol

Outcome Measures

Primary Outcomes (1)

• Completeness of abortion

  Number of Participants with expulsion of Products of conception by visual inspection

  7 days

Secondary Outcomes (2)

• Successful medical abortion

  7 days

• amount of calculated blood loss following treatment

  7 days

Study Arms (2)

misoprostol 400 mcg

EXPERIMENTAL

All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 400 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 (2 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: misoprostol 400 mcg

misoprostol 800 mcg

ACTIVE COMPARATOR

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: misoprostol 800 mcg

Interventions

misoprostol 400 mcg DRUG

All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 400 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 400 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

Also known as: experimental

misoprostol 400 mcg

misoprostol 800 mcg 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 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

Also known as: Active Comparator

misoprostol 800 mcg

Eligibility Criteria

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

You may qualify if:

• 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.

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

• hany farouk: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: a double-blind randomized controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: a double-blind randomized controlled trial

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 2, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)