Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.

Phase 3

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Oxytocin Infusion

• Registration Number: NCT01932060
• Lead Sponsor: Stanford University

Brief Summary

Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to maintain adequate uterine tone after delivery. The study investigators aim to compare two different infusion rates of oxytocin to assess the optimal infusion regimen for reducing blood loss in women undergoing elective Cesarean delivery.

Detailed Description

Oxytocin (pitocin) is a drug commonly used in obstetric practice, and the drug effect is to increase the muscular tone of the uterus to reduce uterine bleeding after neonatal delivery. Pregnant patients undergoing elective (scheduled)Cesarean delivery routinely receive oxytocin after delivery of the baby. Post-delivery, oxytocin is commonly administered as an IV bolus and/or infusion. No previous studies have accurately assessed differences in oxytocin infusions after delivery in patients undergoing elective cesarean delivery. Thus the study aim is to investigate which infusion rate can optimally provide adequate maintenance of uterine tone during Cesarean delivery while being associated with minimal or no maternal side-effects.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-28
• Study First Posted: 2013-08-30
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2016-02-03
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-07
• Last Update Submitted: 2016-12-07
• Results First Posted: 2017-02-01
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

Inclusion Criteria

• Healthy pregnant patients with uncomplicated pregnancies:
• ASA (American Association of Anesthesiologists) class 1 or 2 patients.
• Singleton pregnancies.

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Exclusion Criteria

• ASA class 3 or 4 patients.
• Known drug allergy to intravenous oxytocin.
• Significant medical or obstetric disease.
• Known uterine abnormality.
• Known placental abnormality.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxytocin Infusion 2	Oxytocin Infusion	Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.
Oxytocin Infusion 1	Oxytocin Infusion	Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.

Primary Outcome Measures

Name	Time	Method
Total Estimated Blood Loss	immediately at end of surgery	Blood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps).

Secondary Outcome Measures

Name	Time	Method
Hemoglobin Indices After Cesarean Delivery	24 hr after cesarean delivery	Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery

Trial Locations

Locations (1)

Lucile Packard Children's Hospital, Stanford University; 🇺🇸 Stanford, California, United States