Ideal Time of Oxytocin Infusion During Cesarean Section

Study Overview
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Brief Summary
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This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss. Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta. We hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.

Detailed Description
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Oxytocin is a routinely administered medication for both vaginal and cesarean deliveries in the third stage of labor, as part of standard of care in the United States. This medication helps to reduce overall blood loss, by functioning as a uterotonic. Currently evidence is lacking to direct timing of oxytocin administration in cesarean deliveries. This study will evaluate both estimated and quantitative blood loss for both groups of patients. It will also compare the change from pre-operative to post-operative hemoglobin levels.

Official Title
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Ideal Time of Oxytocin Infusion During Cesarean Section

Conditions
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Blood Loss, Surgical, Postpartum Hemorrhage, Bleed Pregnancy, Pregnancy Related, Cesarean Section Complications

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing cesarean section at Loyola Hospital Women who read and speak the English and/or Spanish language Women age 18 or older Exclusion Criteria: Women who deliver vaginally Gestation under 37 weeks and 0 days Women with coagulopathies Multiple gestation pregnancies Antepartum hemorrhage for example abruption Placental abnormalities for example previa, accreta

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control (Group A)<br>One bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia. This amount of fluid is part of standard of care. | Drug: Placebo<br>* Placebo will be administered after delivery of the placenta<br>|
| Active Comparator: Intervention (Group B)<br>One bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia. This amount of fluid is part of standard of care. | Drug: Oxytocin<br>* Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta<br>* Other names: Pitocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total blood loss | Both the estimated blood loss and quantitative blood loss will be determined | At the completion of the surgery when patient is transferred to recovery from the operating room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postpartum hemorrhage | The number of women who lose 1,000 milliliters or more blood from cesarean delivery | At the completion of the surgery when patient is transferred to recovery from the operating room | 
| Need for transfusion | The number of women who require a blood transfusion due to surgical blood loss | In the immediate 24 hours post surgery | 
| Change in pre-operative to post-operative hemoglobin levels | Hemoglobin levels | Baseline and Post operative day number 1 |