Oxytocin Dosing at Planned Cesarean Section and Anemia

Study Overview
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Brief Summary
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Patient's with planned cesarean sections will be randomized to receive either standard 20 mU in 1L as a bolus following delivery of the placenta or 20 mu in 1L following delivery of the placenta plus an additional 20 mU in 1L over 8 hours.

Detailed Description
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The purpose of this study is to examine the impact of differential dose protocols commonly utilized in the post cesarean period to determine if laboratory definitions of anemia are different. Oxytocin is an antidiuretic hormone that is utilized after delivery of the fetus and placenta to contract the uterus and decrease blood loss both at the time of surgery and in the post-partum period. Here at the Penn State Hershey Medical center the investigators will use 20 units of oxytocin in a 1 L bag of LR in bolus fashion after delivery of the placenta. Other protocols use an extended course of therapy using 20 units of oxytocin in a 1 L bag of LR in a bolus plus an additional 20 units of oxytocin in a 1 L bag of LR over an 8 hour period of time. We hypothesize that: Women who receive the standard 20 mU of oxytocin in 1L of LR in bolus fashion plus 20 mU in 1L over 8 hours will have a decreased reduction in pre-operative vs post-operative hematocrit and hemoglobin versus those that receive 20 mU in 1L of LR. Women who receive the standard 20 mU of oxytocin in 1L of LR in bolus fashion plus 20 mU in 1L over 8 hours will have decreased blood loss by weight in the postpartum period compared to patients who receive 20 mU in 1L of LR.

Official Title
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Oxytocin Dosing at Planned Cesarean Section and Postpartum Anemia: A Comparison of Two Protocols

Conditions
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Blood Loss Anemia, Uterine Atony With Hemorrhage

Intervention / Treatment
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* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned cesarean sections for singletons at or greater than 37 weeks gestational age Primary or repeat cesarean section will be included Exclusion Criteria: Multiple fetal pregnancies Hematologic disorders Fetal anomalies Pre-eclampsia. These patients are at increased risk of fluid overload and so fluid status may be affected by receiving a second bag of fluid containing oxytocin in the postpartum period. Known contraindication to oxytocin Hypersensitivity to oxytocin Patients who have labored and then proceed with cesarean section for any reason. Patients who have labored have had either intrinsic or extrinsic exposure to oxytocin. These patients may have decreased sensitivity to oxytocin.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized double-blinded controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Patient will receive standard post-partum Oxytocin (20 mU in 1 L LR) and 1 L LR over 8 hours following delivery. | Drug: Oxytocin<br>* Administration of additional 20 mU Oxytocin<br>* Other names: Pitocin;|
| Experimental: Treatment<br>Patient will receive standard post-partum Oxytocin(20 mU in 1 L LR) an additional 20 mU Oxytocin in 1 L LR over 8 hours following delivery. | Drug: Oxytocin<br>* Administration of additional 20 mU Oxytocin<br>* Other names: Pitocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss in postpartum period defined by grams/hour | Measure pads used post-partum | 3-4 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin | Pre-op hemoglobin and post-op hemoglobin | 24 hours | 
| Change in Hematocrit | Pre-op hematocrit and post-op hematocrit | 24 hours | 
| Length of hospital stay | Start of surgery to discharge (hours) | 3-4 days after delivery | 
| Need for additional uterotonics | Use of uterotonics | 24 hours after delivery | 
| Continuation of breastfeeding | Is patient breastfeeding at 6 week post-partum visit | 6 weeks | 
| Quantity of narcotic pain medications | Number of narcotic tablets used from time of surgery to discharge | 3-4 days after delivery | 
| Attendance at post-partum visit | Did patient attend post-partum visit? | 6 weeks | 
| Post-partum complications | Did patient have surgical wound infection, endometritis? | 6 weeks | 
| Need for blood transfusion | Did the patient require blood transfusion? | 3-4 days after delivery | 
| Edinburgh post-partum depression scale >10 | Did the patient score greater than 10 points on Edinburgh post-partum depression scale? | 6 weeks |