Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage

Sponsor

hany farouk (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05094375

Collaborator

(none)

200

Enrollment

Location

Arms

19.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Miscarriage	Drug: Vaginal Misoprostol 600 mcg Drug: Vaginal Misoprostol 800 mcg	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

a double-blinded randomized triala double-blinded randomized trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

a double-blinded randomized trial

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

Completeness of abortion [7 days]
expulsion of Products of conception by visual inspection

Secondary Outcome Measures

Successful medical abortion [14 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
Pain resulting from the procedure [7 days]
this will be assessed by the doses of paracetamol given in mg
Additional uterotonic used [14 days]
additional misoprostol doses in mcg

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aswan University Hospital	Aswan		Egypt	81528

Sponsors and Collaborators

hany farouk

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

hany farouk, Clinical Professor, Aswan University Hospital

ClinicalTrials.gov Identifier:

NCT05094375

Other Study ID Numbers:

aswu/354/10/19

First Posted:

Oct 26, 2021

Last Update Posted:

Oct 26, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by hany farouk, Clinical Professor, Aswan University Hospital

miscarriage

vaginal

misoprostol

Additional relevant MeSH terms:

Abortion, Spontaneous

Abortion, Missed

Misoprostol

Study Results

No Results Posted as of Oct 26, 2021