Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage

Vaginal Misoprostol 600 mcg and 800 mcg In Medical Treatment of First Trimester Missed Miscarriage: A Randomized Controlled Trial.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Miscarriage
• Intervention / Treatment: Drug: Vaginal Misoprostol 600 mcg; Drug: Vaginal Misoprostol 800 mcg

Detailed Description

In women with first trimetric-missed miscarriage, vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal misoprostol 600 Mg versus 800 Mg for medical treatment of the first trimester missed miscarriage.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaginal Misoprostol 600 mcg; 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; 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; Other Names: experimental
Active Comparator: Vaginal Misoprostol 800 mcg; 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; 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; Other Names: Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completeness of abortion	expulsion of Products of conception by visual inspection	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding pattern following treatment	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	7 days
Pain resulting from the procedure	this will be assessed by the doses of paracetamol given in mg	7 days
Successful medical abortion	cervical os is closed with endometrial thickness of less than 15 mm	14 days
Additional uterotonic used	additional misoprostol doses in mcg	14 days

Collaborators and Investigators

• Sponsor: hany farouk

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: misoprostol; vaginal; miscarriage
• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Abortion, Missed; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: aswu/354/10/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No