Sublingual Misoprostol 400 mcg and 800 mcg In Medical Treatment of First Trimester Missed Miscarriage: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- misoprostol 400 mcg
- Conditions
- Miscarriage
- Sponsor
- hany farouk
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Completeness of abortion
- Last Updated
- 4 years ago
Overview
Brief Summary
The aim of this work is to compare the effectiveness of sublingual misoprostol 400 mcg versus 800 mcg for medical treatment of the first trimester missed miscarriage.
Detailed Description
the study will be made on female patients with the first trimester missed abortion confirmed by ultrasound. Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol 400 mcg and the other group(B) will receive sublingual Misoprostol 800 mcg every 4 hours in both groups up to 3 doses the aim of the study is to compare the efficacy of sublingual Misoprostol in complete termination of the first trimester missed abortion and which route is the best will less side effects.
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 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.
Arms & Interventions
misoprostol 400 mcg
All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 400 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 (2 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
Intervention: misoprostol 400 mcg
misoprostol 800 mcg
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
Intervention: misoprostol 800 mcg
Outcomes
Primary Outcomes
Completeness of abortion
Time Frame: 7 days
Number of Participants with expulsion of Products of conception by visual inspection
Secondary Outcomes
- Successful medical abortion(7 days)
- amount of calculated blood loss following treatment(7 days)