Misoprostol vs. Sublingual Misoprostol and Laminaria For Second Trimester Termination of Pregnancy

Study Overview
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Brief Summary
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Comparison between the duration of time from the beginning of cervical preparation until abortion, between sublingual misoprostol and the combination of sublingual misoprostol with laminaria for second trimester medical termination of pregnancy (TOP). Comparison between the adverse event rate following Sublingual misoprostol only vs. Sublingual misoprostol and laminaria given for pregnancy termination. Comparison between the levels of satisfaction rate of women who underwent pregnancy termination with sublingual misoprostol vs. sublingual misoprostol with laminaria.

Detailed Description
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A prospective randomized control trial; 50 women undergoing pregnancy termination in the second trimester (14-28 weeks)in each group. Following receiving an ethical approval by the local institutional review board (IRB), committee, consecutively all women in between 14 weeks to 28 weeks; that have a reason for termination of pregnancy like: intrauterine fetal death or medical or genetic indications for termination of pregnancy or socioeconomic termination of pregnancy will be offered to take part in the study. If eligible according to the inclusion and exclusion criteria, women will be asked to sign a consent form. All participants will undergo blood exams (CBC, Prothrombin time, Partial thromboplastin time , and BLOOD TYPING) and ultrasound exam for Confirmation of diagnosis as routinely indicated for missed abortion at our department

Official Title
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Comparison Between Sublingual Misoprostol vs. Sublingual Misoprostol and Laminaria For Second Trimester Termination of Pregnancy

Conditions
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Other Abortion

Intervention / Treatment
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* Drug: Cytotec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Second trimester pregnancy No evidence of chorioamnionitis Exclusion Criteria: Allergy to misoprostol. Evidence for infection. Asthma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laminaria<br>cytotec and laminaria | Drug: Cytotec<br>* Cytotec medication compared with cytotec and laminaria<br>* Other names: Misorpristol vs. Misopristol and laimnria;|
| Active Comparator: Cytotec<br>Cytotec only | Drug: Cytotec<br>* Cytotec medication compared with cytotec and laminaria<br>* Other names: Misorpristol vs. Misopristol and laimnria;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of time until pregnancy termination | From the time of receiving the treatment until complete abortion | Average time 12 hours |