Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage

hany farouk

Status: Unknown

Conditions: Miscarriage

Treatments: Drug: Vaginal Misoprostol 800 mcg; Drug: Vaginal Misoprostol 600 mcg

Study type: Interventional

Funder types: Other

Identifiers

NCT05094375

aswu/354/10/19

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Vaginal Misoprostol 600 mcg

Experimental group

Description:

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

Treatment:

Drug: Vaginal Misoprostol 600 mcg

Vaginal Misoprostol 800 mcg

Active Comparator group

Description:

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

Treatment:

Drug: Vaginal Misoprostol 800 mcg