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| Name | Class |
|---|---|
| El Galaa Teaching Hospital | OTHER |
| University of Alexandria | OTHER |
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The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage compared to intramuscular (IM) injection.
The study will compare the effect of IV infusion or IV bolus to IM oxytocin administration with respect to mean blood loss and the proportion of women who experience blood loss greater than or equal to 500 ml, women who experience blood loss greater than or equal to 350 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV infusion | Active Comparator | Oxytocin 10 IU will be administered by IV infusion according to randomization assignment as soon as possible after delivery of the baby. |
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| IV bolus | Active Comparator | Oxytocin 10 IU will be administered by IV bolus according to randomization assignment as soon as possible after delivery of the baby. |
|
| IM injection | Active Comparator | Oxytocin 10 IU will be administered by IM injection according to randomization assignment as soon as possible after delivery of the baby. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women with postpartum blood loss equal to or greater than 500 mL | Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container. | 1 hour after delivery of baby |
| Measure | Description | Time Frame |
|---|---|---|
| Mean postpartum blood loss | Mean blood loss as measured in a plastic, calibrated container. | 1 hour after delivery of the baby |
| Proportion of women with postpartum blood loss equal to or greater than 350 mL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Rasha Dabash, MPH | Gynuity Health Projects | Principal Investigator |
| Ilana Dzuba, MHS | Gynuity Health Projects | Principal Investigator |
| Jill Durocher | Gynuity Health Projects | Principal Investigator |
| Dyanna Charles, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shatby Maternity Hospital, Alexandria University | Alexandria | Egypt | ||||
| El Galaa Teaching Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33169839 | Derived | Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4. | |
| 30658605 | Derived | Charles D, Anger H, Dabash R, Darwish E, Ramadan MC, Mansy A, Salem Y, Dzuba IG, Byrne ME, Breebaart M, Winikoff B. Intramuscular injection, intravenous infusion, and intravenous bolus of oxytocin in the third stage of labor for prevention of postpartum hemorrhage: a three-arm randomized control trial. BMC Pregnancy Childbirth. 2019 Jan 18;19(1):38. doi: 10.1186/s12884-019-2181-2. |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.
| 1 hour after delivery of the baby |
| Proportion of women with postpartum blood loss equal to or greater than 1000 mL | Postpartum blood loss equal to or greater than 1000 mL as measured in a plastic, calibrated container. | 1 hour after delivery |
| Mean change in hemoglobin pre-delivery to postpartum | Hemoglobin will be measured in g/dL using the Hemocue machine. Pre-delivery hemoglobin will be taken during labor. | At least 12 hours after removal of IV and within 48 hours of delivery of the baby |
| Time to delivery of placenta | Time interval in minutes between delivery of the baby and delivery of the placenta | Within 1 hour of delivery of the baby |
| Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy | Within 1 hour of delivery of the baby |
| Side effects 1 hour postpartum | 1 hour after delivery of the baby |
| Cairo |
| Egypt |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |