Oxytocin Dosing at Planned Cesarean Section and Anemia

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Blood Loss Anemia; Uterine Atony With Hemorrhage
• Intervention / Treatment: Drug: Oxytocin

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.

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control; Patient will receive standard post-partum Oxytocin (20 mU in 1 L LR) and 1 L LR over 8 hours following delivery.	Drug: Oxytocin; Administration of additional 20 mU Oxytocin; Other Names: Pitocin
EXPERIMENTAL: Treatment; 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; Administration of additional 20 mU Oxytocin; Other Names: Pitocin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Helana Pietragallo, MD, Penn State College of Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2019
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (ACTUAL): December 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Pregnancy Complications; Obstetric Labor Complications; Dystocia; Hemorrhage; Anemia; Uterine Inertia; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 00006502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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