Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage

Study Overview
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Brief Summary
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The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

Detailed Description
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In women with first trimetric-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

Official Title
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Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage: A Randomized Controlled Trial.

Conditions
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Missed Abortion

Intervention / Treatment
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* Drug: sublingual misoprostol
* Drug: vaginal misoprostol


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. The size of the uterus on pelvic examination was compatible with the estimated duration of pregnancy 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 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sublingual misoprostol<br>Group A (100 patients): will be treated with sublingual misoprostol | Drug: sublingual misoprostol<br>* 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 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 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: Misotac;|
| Active Comparator: vaginal misoprostol<br>Group B (100 patients): will be treated with vaginal misoprostol | Drug: vaginal misoprostol<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. Paracetamol, eight hourly, will be provided as analgesic or antipyretic<br>* Other names: Misotac;|

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 (POC)x 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 |  | 7 days | 
| Failure: endometrial thickness of more than 15 mm on day seven (from third dose of misoprostol) or developing of complications before day seven needing early surgical evacuation. |  | 7 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 | 7 days |