IV vs IM Oxytocin in the Third Stage of Labor 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 IV infusion results in a lower mean blood loss compared to IM injection.

Detailed Description
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The study will compare the effect of IV infusion and IM oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. It will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.

Official Title
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Intravenous and Intramuscular Administration of Oxytocin 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
* 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: Women who are: Planned or transferred for delivery via Cesarean section Not delivering a live birth Unable to provide informed consent due to mental impairment, distress during labor or other reason Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV infusion<br>Oxytocin 10 IU will be administered IV infusion according to randomization assignment as soon as possible after delivery of the baby. | Drug: Oxytocin<br>* 10 IU oxytocin in 500 ml infusion<br>|
| Active Comparator: IM Injection<br>Oxytocin 10 IU will be administered IM according to randomization assignment as soon as possible after delivery of the baby. | Drug: Oxytocin<br>* 10 IU oxytocin IM injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood loss (ml) |  | minimum of 1 hour after delivery of baby | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml |  | minimum of 1 hour after delivery of baby | 
| Change in hemoglobin from pre-delivery to postpartum | Post-delivery hemoglobin using a Hemocue® Hemoglobin machine + cuvette will be taken at least 24 after delivery and before the woman leaves the facility. If the woman has received IV fluids, hemoglobin will be measured at least 12 hours after removal of the IV prior to discharge. | 12-24 hours after delivery | 
| Time to placental delivery |  | minimum of 1 hour after delivery of baby | 
| Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy |  | minimum of 1 hour after delivery of baby | 
| Side effects 1 hour postpartum |  | 1 hour postpartum | 
| Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward |  | arrival to labor ward | 

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