Misoprostol for Second Trimester Termination of Pregnancy

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3 hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable pregnancy

Official Title
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A Comparison Between Vaginal Misoprostol vs. Buccal Misoprostol For Second Trimester Termination of Pregnancy

Conditions
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Abortion, Induced

Intervention / Treatment
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* Drug: Vaginal misoprostol
* Drug: Buccal misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gestational age between 12-24 weeks live fetus singleton pregnancy Bishop score <5 no uterine contraction Exclusion Criteria: prostaglandin allergy a scar in uterus uterine abnormality premature rupture of membranes

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Buccal misoprostol<br>400 µg buccal misoprostol per 3 hours | Drug: Buccal misoprostol<br>* 400 µg buccal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg buccal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.<br>* Other names: Cytotec;|
| Active Comparator: vaginal misoprostol<br>400 µg vaginal misoprostol per 3 hours | Drug: Vaginal misoprostol<br>* 400 µg vaginal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg vaginal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.<br>* Other names: Cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction to fetal expulsion interval | Time elapsed between administration of the first misoprostol dose until expulsion of the fetus | 15 minutes after fetus delivered | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery within 24 hours |  | 24 hour | 
| Delivery within 48 hours |  | 48 hours | 
| Use of additional interventions | the patients who did not delivered within 48 hours will considered as failed induction and will be offered another method of induction/delivery or to continue same protocol. | One week | 
| Expected pain before induction and perceived (actual) pain after abortion completed | Expected and perceived pain will be measured by VAS | within 1 hour after randomisation and after 12 hour after complete abortion/placenta removed | 
| Rate of complete abortion |  | 12 hour after fetus and placenta removed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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misoprostol, Labor, Induced, Pregnancy Trimester, Second, Abortion, Induced