Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage

NCT05094375 | Unknown DMC

• 1 other identifier: aswu/354/10/19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy of vaginal misoprostol 600 Mg versus 800 Mg in termination of the first trimester missed abortion were assist

Conditions

Miscarriage

Keywords

miscarriage; vaginal; misoprostol

Outcome Measures

Primary Outcomes (1)

• Completeness of abortion

  expulsion of Products of conception by visual inspection

  7 days

Secondary Outcomes (4)

• Successful medical abortion

  14 days

• Bleeding pattern following treatment

  7 days

• Pain resulting from the procedure

  7 days

• Additional uterotonic used

  14 days

Study Arms (2)

Vaginal Misoprostol 600 mcg

EXPERIMENTAL

All patients will receive three doses of vaginal misoprostol every four hours. The first dose of misoprostol 600 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 600 mcg each (3 tablets of 200 mcg per dose). * Paracetamol, eight hourlies, 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

Drug: Vaginal Misoprostol 600 mcg

Vaginal Misoprostol 800 mcg

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. * Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). * Paracetamol, eight hourlies, 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

Drug: Vaginal Misoprostol 800 mcg

Interventions

Vaginal Misoprostol 600 mcg DRUG

All patients will receive three doses of vaginal misoprostol every four hours. The first dose of misoprostol 600 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 600 mcg each (3 tablets of 200 mcg per dose). * Paracetamol, eight hourlies, 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

Vaginal Misoprostol 600 mcg

Vaginal Misoprostol 800 mcg 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 second dose will be given upon sending home. * Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). * Paracetamol, eight hourlies, 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: Active Comparator

Vaginal Misoprostol 800 mcg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnant women with missed abortion
• 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 , 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

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: a double-blinded randomized trial

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 26, 2021
• Study Start: November 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)