Ideal Time of Oxytocin Infusion During Cesarean Section

Phase 4

Terminated

• Conditions: Cesarean Section Complications; Blood Loss, Surgical; Postpartum Hemorrhage; Pregnancy Related; Bleed Pregnancy
• Interventions: Drug: Placebo; Drug: Oxytocin

• Registration Number: NCT03246919
• Lead Sponsor: Loyola University

Brief Summary

This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss. Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta. We hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.

Detailed Description

Oxytocin is a routinely administered medication for both vaginal and cesarean deliveries in the third stage of labor, as part of standard of care in the United States. This medication helps to reduce overall blood loss, by functioning as a uterotonic. Currently evidence is lacking to direct timing of oxytocin administration in cesarean deliveries.

This study will evaluate both estimated and quantitative blood loss for both groups of patients. It will also compare the change from pre-operative to post-operative hemoglobin levels.

Study Timeline

• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-11
• Study Start: 2017-09-13
• Status Verified: 2019-08
• Primary Completion: 2020-02-24
• Study Completion: 2020-02-24
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• Women undergoing cesarean section at Loyola Hospital
• Women who read and speak the English and/or Spanish language
• Women age 18 or older

Exclusion Criteria

• Women who deliver vaginally
• Gestation under 37 weeks and 0 days
• Women with coagulopathies
• Multiple gestation pregnancies
• Antepartum hemorrhage for example abruption
• Placental abnormalities for example previa, accreta

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (Group A)	Placebo	One bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia. This amount of fluid is part of standard of care.
Intervention (Group B)	Oxytocin	One bag of 500 ml 0.9% NaCl with 30 units of Oxytocin (Oxytocin solution) will be hung by Anesthesia when the fetal anterior shoulder delivers. After the placenta is delivered, then one bag of 500 ml 0.9% NaCl (normal saline) will be hung by Anesthesia. This amount of fluid is part of standard of care.

Primary Outcome Measures

Name	Time	Method
Total blood loss	At the completion of the surgery when patient is transferred to recovery from the operating room	Both the estimated blood loss and quantitative blood loss will be determined

Secondary Outcome Measures

Name	Time	Method
Incidence of postpartum hemorrhage	At the completion of the surgery when patient is transferred to recovery from the operating room	The number of women who lose 1,000 milliliters or more blood from cesarean delivery
Need for transfusion	In the immediate 24 hours post surgery	The number of women who require a blood transfusion due to surgical blood loss
Change in pre-operative to post-operative hemoglobin levels	Baseline and Post operative day number 1	Hemoglobin levels

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States