Vaginal Misoprostol 600 mcg and 800 mcg In Medical Treatment of First Trimester Missed Miscarriage: A Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Vaginal Misoprostol 600 mcg
- Conditions
- Miscarriage
- Sponsor
- hany farouk
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Completeness of abortion
- Last Updated
- 4 years ago
Overview
Brief Summary
Efficacy of vaginal misoprostol 600 Mg versus 800 Mg in termination of the first trimester missed abortion were assist
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.
Investigators
hany farouk
Clinical Professor
Aswan University Hospital
Eligibility Criteria
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.
Arms & Interventions
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: Vaginal Misoprostol 600 mcg
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
Intervention: Vaginal Misoprostol 800 mcg
Outcomes
Primary Outcomes
Completeness of abortion
Time Frame: 7 days
expulsion of Products of conception by visual inspection
Secondary Outcomes
- Pain resulting from the procedure(7 days)
- Bleeding pattern following treatment(7 days)
- Additional uterotonic used(14 days)
- Successful medical abortion(14 days)