Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage

NCT ID: NCT05094375

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Miscarriage

Keywords

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miscarriage vaginal misoprostol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a double-blinded randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
a double-blinded randomized trial

Study Groups

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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

Group Type EXPERIMENTAL

Vaginal Misoprostol 600 mcg

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Vaginal Misoprostol 800 mcg

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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experimental Active Comparator

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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hany farouk

OTHER

Sponsor Role lead

Responsible Party

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hany farouk

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Aswan University Hospital

Aswān, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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aswu/354/10/19

Identifier Type: -

Identifier Source: org_study_id