Control of Blood Loss During Caesarean Section

Study Overview
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Brief Summary
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trial of 3 protocols to determine the best one to control blood loss during caesarean section

Detailed Description
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The study population will be divided into 3 groups each containing 200 women: Group (A): 200 patients will receive 5-IU oxytocin bolus over 3 minutes after delivery of the baby. Group (B): 200 patients will receive 5-IU oxytocin bolus over 3 minutes and 30-IU oxytocin infusion in 500 ml 0.9 % saline over 4 hours after delivery of the baby. Group (C): 200 patients will receive misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity. Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward. Hemoglobin level and haematocrit value will be done as follow:- After admission of each case in the pre-operative period. Immediately post- operative. 24 hours post- operative.

Official Title
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A Randomized Trial to Determine the Best Strategy for the Control of Blood Loss at Elective Caesarean Section

Conditions
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Complications; Cesarean Section

Intervention / Treatment
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* Drug: oxytocin
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients booked for elective cesarean section. Singleton pregnancies. Primigravida or multipara ,first cesarean section or previous . Exclusion Criteria: Patients with obstetric hemorrhage. Uterine laceration. Placenta previa. Blood dyscrasias. Large fibroids. Multiple pregnancy. Pre-eclampsia. Marked maternal anemia. Previous history of PPH.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oxytocin bolus<br>5 IU bolus iv over 3 minutes after delivery of the baby Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward. Hemoglobin level and haematocrit value will be done as follow:- After admission of each case in the pre-operative period. Immediately post- operative. 24 hours post- operative. | Drug: oxytocin<br>* group I : oxytocin 5 IU bolus over 3 minutes after delivery of the baby group II : oxytocin 5 IU bolus over 3 minutes after delivery of the baby and oxytocin infusion in 500 ml 0.9% saline over 4 hours<br>* Other names: syntocinon;|
| Active Comparator: oxytocin bolus & oxytocin infusion<br>5 IU oxytoxin bolus over 3 minutes and 30 IU oxytocin infusion in 500 ml 0.9% saline over 4 hours after delivery of the baby | Drug: oxytocin<br>* group I : oxytocin 5 IU bolus over 3 minutes after delivery of the baby group II : oxytocin 5 IU bolus over 3 minutes after delivery of the baby and oxytocin infusion in 500 ml 0.9% saline over 4 hours<br>* Other names: syntocinon;|
| Active Comparator: misoprostol intrauterine<br>misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity | Drug: Misoprostol<br>* misoprostol intrauterine 800 microgram placed intrauterine after delivery of the baby & the placenta<br>* Other names: cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of blood loss |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin % and haematocrit value |  | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caesarean section, intrapartum haemorrhage