Oxytocin Via Intramuscular Injection and Intravenous Bolus or Infusion for Prevention of Postpartum Hemorrhage

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Administration of Oxytocin Via Intramuscular Injection and Intravenous Bolus or Intravenous Infusion in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women who present in active labor for a live birth at the study hospital will be considered for participation in the study Exclusion Criteria: Planned or transferred for delivery via Cesarean section Administration of a pre-delivery uterotonic to induce or augment labor Unable to provide informed consent due to mental impairment, distress during labor or other reason

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV infusion<br>Oxytocin 10 IU will be administered by IV infusion according to randomization assignment as soon as possible after delivery of the baby. | Drug: Oxytocin<br> <br> |
| Active Comparator: IV bolus<br>Oxytocin 10 IU will be administered by IV bolus according to randomization assignment as soon as possible after delivery of the baby. | Drug: Oxytocin<br> <br> |
| Active Comparator: IM injection<br>Oxytocin 10 IU will be administered by IM injection according to randomization assignment as soon as possible after delivery of the baby. | Drug: Oxytocin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum hemorrhage, Oxytocin, Prevention, Third stage of labor, Hemoglobin, Intravenous, Intramuscular, Bolus