Oxytocin Dosing at Planned Cesarean Section and Anemia
Primary Purpose
Blood Loss Anemia, Uterine Atony With Hemorrhage
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss Anemia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Treatment
Arm Description
Patient will receive standard post-partum Oxytocin (20 mU in 1 L LR) and 1 L LR over 8 hours following delivery.
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.
Outcomes
Primary Outcome Measures
Blood loss in postpartum period defined by grams/hour
Measure pads used post-partum
Secondary Outcome Measures
Change in Hemoglobin
Pre-op hemoglobin and post-op hemoglobin
Change in Hematocrit
Pre-op hematocrit and post-op hematocrit
Length of hospital stay
Start of surgery to discharge (hours)
Need for additional uterotonics
Use of uterotonics
Continuation of breastfeeding
Is patient breastfeeding at 6 week post-partum visit
Quantity of narcotic pain medications
Number of narcotic tablets used from time of surgery to discharge
Attendance at post-partum visit
Did patient attend post-partum visit?
Post-partum complications
Did patient have surgical wound infection, endometritis?
Need for blood transfusion
Did the patient require blood transfusion?
Edinburgh post-partum depression scale >10
Did the patient score greater than 10 points on Edinburgh post-partum depression scale?
Full Information
NCT ID
NCT03361124
First Posted
August 1, 2017
Last Updated
February 19, 2019
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03361124
Brief Title
Oxytocin Dosing at Planned Cesarean Section and Anemia
Official Title
Oxytocin Dosing at Planned Cesarean Section and Postpartum Anemia: A Comparison of Two Protocols
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator no longer interested in proceeding with study
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss Anemia, Uterine Atony With Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized double-blinded controlled
Masking
ParticipantInvestigator
Masking Description
Covering of labels on IV fluids
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patient will receive standard post-partum Oxytocin (20 mU in 1 L LR) and 1 L LR over 8 hours following delivery.
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
Administration of additional 20 mU Oxytocin
Primary Outcome Measure Information:
Title
Blood loss in postpartum period defined by grams/hour
Description
Measure pads used post-partum
Time Frame
3-4 days after delivery
Secondary Outcome Measure Information:
Title
Change in Hemoglobin
Description
Pre-op hemoglobin and post-op hemoglobin
Time Frame
24 hours
Title
Change in Hematocrit
Description
Pre-op hematocrit and post-op hematocrit
Time Frame
24 hours
Title
Length of hospital stay
Description
Start of surgery to discharge (hours)
Time Frame
3-4 days after delivery
Title
Need for additional uterotonics
Description
Use of uterotonics
Time Frame
24 hours after delivery
Title
Continuation of breastfeeding
Description
Is patient breastfeeding at 6 week post-partum visit
Time Frame
6 weeks
Title
Quantity of narcotic pain medications
Description
Number of narcotic tablets used from time of surgery to discharge
Time Frame
3-4 days after delivery
Title
Attendance at post-partum visit
Description
Did patient attend post-partum visit?
Time Frame
6 weeks
Title
Post-partum complications
Description
Did patient have surgical wound infection, endometritis?
Time Frame
6 weeks
Title
Need for blood transfusion
Description
Did the patient require blood transfusion?
Time Frame
3-4 days after delivery
Title
Edinburgh post-partum depression scale >10
Description
Did the patient score greater than 10 points on Edinburgh post-partum depression scale?
Time Frame
6 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helana Pietragallo, MD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Oxytocin Dosing at Planned Cesarean Section and Anemia
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