Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section

Study Overview
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Brief Summary
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This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till October 2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.

Official Title
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Preoperative vs. Postoperative Misoprostol in Elective Cesarean Section: A Double-blind Randomized Clinical Trial

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: Misoprostol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients booked for elective cesarean section. Singleton pregnancies. Full term pregnancies (GA 37- 42 Wks). Age (18-40 yrs). body mass index (BMI) (20-30(Kg/m2 . Exclusion Criteria: Contraindication to spinal anesthesia. Blood dyscrasias. Large fibroids. Multiple pregnancies. Overdistended uterus eg. Hydramnios. Pre-eclampsia. Marked maternal anemia (Preoperative hemoglobin < 9 gm/dl). Previous history of PPH. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol. Placenta previa. Previous myomectomy. Extreme of BMI (<20 or >30 Kg/m2 ).

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preoperative<br>• Group no.1 will receive preoperative sublingual 400 microgram of misoprostol (Sigma) 2 tablets and postoperative sublingual placebo2 tablets. | Drug: Misoprostol<br>* mesotac<br>Other: Placebo<br>* Placebo tablet identical to the misoprostol tablet but without the active ingredient<br>|
| Active Comparator: Postoperative<br>• Group no.2 will receive preoperative sublingual placebo 2 tablets and postoperative sublingual 400 microgram of misoprostol (Sigma)  2 tablets . | Drug: Misoprostol<br>* mesotac<br>Other: Placebo<br>* Placebo tablet identical to the misoprostol tablet but without the active ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for extra uterotonics |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss |  | intraoperative | 
| postpartum hemorrhage |  | 24 hours | 
| neonatal outcome | measured by APGAR score at 1 and 5 minutes | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, Misoprostol, sublingual, uterotonics