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

Sponsor

Aswan University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05088707

Collaborator

(none)

200

Enrollment

Location

Arms

16.9

Anticipated Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Miscarriage	Drug: sublingual misoprostol Drug: vaginal misoprostol	N/A

Detailed Description

In women with second trimester-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

an open-label randomized controlled studyan open-label randomized controlled study

Masking:

None (Open Label)

Masking Description:

an open-label randomized controlled study

Primary Purpose:

Treatment

Official Title:

Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage: A Randomized Controlled Trial

Anticipated Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sublingual misoprostol 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 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 Other Names: experimental
Active Comparator: vaginal misoprostol 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 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 Other Names: Active Comparator

Arm

Intervention/Treatment

Experimental: sublingual misoprostol

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

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

Other Names:

experimental

Active Comparator: vaginal misoprostol

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

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 [7 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

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
between 13-26 weeks of gestation.
Pregnancy is confirmed by a 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 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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Aswan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

hany farouk, A Professor, Aswan University Hospital

ClinicalTrials.gov Identifier:

NCT05088707

Other Study ID Numbers:

aswu/354/3/18

First Posted:

Oct 22, 2021

Last Update Posted:

Oct 22, 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, A Professor, Aswan University Hospital

Additional relevant MeSH terms:

Abortion, Spontaneous

Abortion, Missed

Misoprostol

Study Results

No Results Posted as of Oct 22, 2021