Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss

Study Overview
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Brief Summary
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The aim of the work is to evaluate & compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood loss during and after the operation.

Official Title
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COMPARISON BETWEEN RECTAL & SUBLINGUAL MISOPROSTOL BEFORE CAESARIAN SECTION TO REDUCE INTRA & POST-OPERATIVE BLOOD LOSS

Conditions
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Postpartum Hemorrhage

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. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section Exclusion Criteria: Primigravida. 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. Contraindication to spinal anesthesia. Previous myomectomy. Previous two or more C.S.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sublingual misoprostol & rectal placebo<br>will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets. | Drug: Misoprostol<br>* Comparison of different routes of administration of 400 micro gram misoprostol<br>* Other names: Cytotec;|
| Placebo Comparator: rectal & sublingual placebo<br>will receive rectal placebo2 tablets and sublingual placebo2 tablets. | Other: Placebo<br> <br> |
| Experimental: rectal misoprostol & sublingual placebo<br>will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets. | Drug: Misoprostol<br>* Comparison of different routes of administration of 400 micro gram misoprostol<br>* Other names: Cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Blood Loss |  | from start of cesarean section till the end of operation (average one hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Extra Ecbolics (Oxytocin). |  | from start of cesarean section till the end of operation (average one hour) | 
| APGAR Score | The Apgar score is the first test given to a newborn, it is referred to as an acronym for: Appearance, Pulse, Grimace, Activity, and Respiration. Scores obtainable are between 10 and 0, with 10 being the highest possible score. Pulse: above 100 beats per minute (2), below 100 beats per minute (1), absent (0). Respiration: Normal rate and effort, good cry (2), Slow or irregular,weak cry (1), absent (0). Grimace: Pulls away, sneezes, coughs, or cries with stimulation (2), Facial movement only (1), absent (0). Activity: Active, spontaneous movement (2), Arms and legs flexed with little movement (1), absent (0). Appearance: Normal color (2), Normal color (but hands and feet are bluish) (1), Bluish-gray or pale all over (0). | 1minute and 5 minutes from delivery of the fetus | 
| Time to Resume Bowel Habits |  | average 24 hours | 
| Need for Extra Analgesics |  | average 24 hours | 
| Need for Postoperative Blood Transfusion |  | average 24 hours | 
| Incidence of Wound Sepsis |  | upto one week | 
| Incidence of Adverse Effects |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum hemorrhage, Intrapartum blood loss, Misoprostol