Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?

Study Overview
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Brief Summary
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Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects on either mother or baby. The aim of the this study is to address if there is any benefits 'regarding the intra-operative blood loss' from preoperative rectal administration of 400 mic of Misoprostol in addition to the routinely administrated 10 units of oxytocin

Detailed Description
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Research question: In women undergoing elective ceserean section, is preoperative 400 mic Misoprostol reduce intra-operative blood loss? Research hypothesis: pre-operative Misoprostol doesn't reduce intraoperative blood loss in women undergoing ceserean section

Official Title
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Randomized, Placebo-controlled Double Blind Study of Preoperative Misorostol for Reduction of Intraoperative Bleeding in Women Delivered by Ceserean Section

Conditions
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Postpartum Haemorrhage

Intervention / Treatment
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* Drug: misoprostol
* Drug: placeboo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 38-41 weeks of amenorrhea scheduled for elective lower segment cesarean section Exclusion Criteria: confirmed intrauterine fetal death more than previous 2 ceserean sections multiple pregnancy antepartum haemorrhage self-reported maternal heart disease current diagnosis of severe malaria or acute bacterial infection

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 |
| --- | --- |
| Experimental: misoprostol<br>women receiving pre-operative rectally administered 400 microgram misoprostol | Drug: misoprostol<br>* 400 microgram of misoprostol is given preoperatively in patients undergoing elective cesarean section<br>* Other names: mesotac;|
| Active Comparator: placeboo<br>women receiving placebo | Drug: placeboo<br>* women will recive 2 identical tablets as placeboo<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume of intraoperative blood loss | volume of intraoperative blood loss will be measured in cc by a didcated nurse who will use separate suction sets to differentiate between blood and liquor | 30 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal mortality |  | 6 months | 
| mean measured blood loss |  | 1, 2, and 24 h postpartum | 
| placental retention | when the placenta is not delivered spontaneously for 30 minutes | 30 minutes | 
| requirement for blood transfusion | indicated per clinical protocol at the study site for mothers with a hemoglobin <100 g/l and/or severe pallor | 24 hours | 
| requirement for additional management of PPH, including therapeutic uterotonic drugs or surgical or radiological procedures |  | 24 hours | 
| postpartum hemoglobin | less than 10gm% | 24 hours | 
| mean postpartum hematocrit | more than 10% drop in the postpartum hematocrit | 24 hours |