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

NCT ID: NCT01932060

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-09-30

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.

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oxytocin Infusion 1

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.

Group Type: EXPERIMENTAL

Oxytocin Infusion

Intervention Type: DRUG

Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.

Oxytocin Infusion 2

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.

Group Type: ACTIVE_COMPARATOR

Oxytocin Infusion

Intervention Type: DRUG

Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.

Interventions

Oxytocin Infusion

Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.

Intervention Type: DRUG

Other Intervention Names

Oxytocin; Pitocin

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Alex James Butwick

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander J Butwick, F.R.C.A.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Lucile Packard Children's Hospital, Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

28015

Identifier Type: -

Identifier Source: org_study_id