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trial of 3 protocols to determine the best one to control blood loss during caesarean section
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:-
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxytocin bolus | Active Comparator | 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:-
|
|
| oxytocin bolus & oxytocin infusion | Active Comparator | 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 |
|
| misoprostol intrauterine | Active Comparator | misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxytocin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| amount of blood loss | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin % and haematocrit value | 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waleed M El-khayat, M.D. | Lecturer of Obstetrics & Gynecology , Faculty of medicine, Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of medicine , Cairo University | Cairo | Cairo Governorate | 12211 | Egypt |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Misoprostol | Drug | misoprostol intrauterine 800 microgram placed intrauterine after delivery of the baby & the placenta |
|
|
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |