Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.

Study Overview
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Brief Summary
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Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to maintain adequate uterine tone after delivery. The study investigators aim to compare two different infusion rates of oxytocin to assess the optimal infusion regimen for reducing blood loss in women undergoing elective Cesarean delivery.

Detailed Description
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Oxytocin (pitocin) is a drug commonly used in obstetric practice, and the drug effect is to increase the muscular tone of the uterus to reduce uterine bleeding after neonatal delivery. Pregnant patients undergoing elective (scheduled)Cesarean delivery routinely receive oxytocin after delivery of the baby. Post-delivery, oxytocin is commonly administered as an IV bolus and/or infusion. No previous studies have accurately assessed differences in oxytocin infusions after delivery in patients undergoing elective cesarean delivery. Thus the study aim is to investigate which infusion rate can optimally provide adequate maintenance of uterine tone during Cesarean delivery while being associated with minimal or no maternal side-effects.

Official Title
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Effects of Different Oxytocin Infusions on Blood Loss and Postpartum Hemoglobin Values in Patients Undergoing Elective Cesarean Delivery

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Oxytocin Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy pregnant patients with uncomplicated pregnancies: ASA (American Association of Anesthesiologists) class 1 or 2 patients. Singleton pregnancies. Exclusion Criteria: ASA class 3 or 4 patients. Known drug allergy to intravenous oxytocin. Significant medical or obstetric disease. Known uterine abnormality. Known placental abnormality.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin Infusion 1<br>Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit. | Drug: Oxytocin Infusion<br>* Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.<br>* Other names: Oxytocin; Pitocin;|
| Active Comparator: Oxytocin Infusion 2<br>Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit. | Drug: Oxytocin Infusion<br>* Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.<br>* Other names: Oxytocin; Pitocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Estimated Blood Loss | Blood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps). | immediately at end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Indices After Cesarean Delivery | Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery | 24 hr after cesarean delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxytocin, blood loss, Cesarean delivery