Oxytocin Dosing at Planned Cesarean Section and Anemia

Uterine Atony With Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03361124
• Other study ID #: 00006502
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: February 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Blood Loss Anemia
• Hemorrhage
• Uterine Atony With Hemorrhage
• Uterine Inertia

Intervention

Drug:
• Oxytocin
Administration of additional 20 mU Oxytocin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Outcome

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