Comparative Study Between Combined Vaginal Misoprostol

Study Overview
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Brief Summary
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Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate

Detailed Description
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Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate versus Misoprostol Alone For Induction Of The first trimester Missed Abortion A Randomized Clinical Trial

Official Title
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Comparative Study Between Combined Vaginal Misoprostol With Isosorbide-5-Mononitrate Versus Misoprostol Alone For Induction Of The First Trimester Missed Abortion A Randomized Clinical Trial

Conditions
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Missed Abortion

Intervention / Treatment
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* Drug: Misoprostol and iso sorbide mononitrates


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Maternal Age 18 - 35 years. Gestational age first trimester of pregnancy (between 5-13 weeks). Missed abortion confirmed by ultrasound. Singleton pregnancy. Normal uterus and cervix on clinical examination. Cervix is not dilated. No vaginal bleeding. Exclusion Criteria:- Evidences suggesting start of spontaneous abortion and previous trial to induce abortion. Presence of uterine contraction or bleeding, Multi-fetal pregnancy. Suspicion of septic abortion. History of Previous cervical surgery or manipulation. Ex: cervical tear , cervical cauterization . Uterine anomaly. Presence of IUD( intrauterine device) in situ Underlying medical diseases.Ex:diabetes mellitus,hypertension History of allergy or adverse effects to vaginally administered medication e.g. isosorbide -5- mononitrate Those unwilling to participate in the trial Higher order cesarean section(more than three

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 Randomized Clinical Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients who recieve misoprostol alone<br>Group A (n =30 ) will receive only vaginal Misoprostol 800mcg (4 tablets Cytotec 200mcg ) ) every 3 hours to a maximum of two doses or until reaching cervical ripening or uterine contractions or bleeding assessed by the same doctor who made evaluation at the beginning. | Drug: Misoprostol and iso sorbide mononitrates<br>* drug<br>* Other names: misotac and effox;|
| Active Comparator: patients who recieve misoprostol and iso sorbide mononitrate<br>Group B (n =30 ) will receive combined vaginal Misoprostol 800mcg (4 tablets Cytotec ) ) every 3 hours to a maximum of two doses or until reaching cervical ripening or start of uterine contractions or bleeding. with Isosorbide-5-mononitrate (20 mg). Effox 20 mg )once at the beginning with misoprostol until reaching cervical ripening or start of and uterine contractions assessed by the same doctor who made the evaluation at the beginning. | Drug: Misoprostol and iso sorbide mononitrates<br>* drug<br>* Other names: misotac and effox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction to abortion interval | Induction to abortion interval: the Duration interval between the beginning of the induction and beginning of cervical ripening assessed by cervical examination(cervix become soft and start to dilate) and uterine contractions leading to complete expulsion of the abortus spontaneous and if cervical ripening isn't occur by maximum doses the investigators will make surgical evacuation. | 6 months | 
| Number of the doses | the Number of the doses of misoprostol needed to complete expulsion (spontaneous or surgical) | 6 months |