Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage

Study Overview
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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.

Official Title
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Vaginal Misoprostol 600 mcg and 800 mcg In Medical Treatment of First Trimester Missed Miscarriage: A Randomized Controlled Trial.

Conditions
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Miscarriage

Intervention / Treatment
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* Drug: Vaginal Misoprostol 600 mcg
* Drug: Vaginal Misoprostol 800 mcg


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a double-blinded randomized trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Misoprostol 600 mcg<br>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 | Drug: Vaginal Misoprostol 600 mcg<br>* 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<br>* Other names: experimental;|
| Active Comparator: Vaginal Misoprostol 800 mcg<br>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 | Drug: Vaginal Misoprostol 800 mcg<br>* 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<br>* Other names: Active Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completeness of abortion | expulsion of Products of conception by visual inspection | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful medical abortion | cervical os is closed with endometrial thickness of less than 15 mm | 14 days | 
| Bleeding pattern following treatment | 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 | 7 days | 
| Pain resulting from the procedure | this will be assessed by the doses of paracetamol given in mg | 7 days | 
| Additional uterotonic used | additional misoprostol doses in mcg | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal, misoprostol, miscarriage