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

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oxytocin Infusion
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring Oxytocin, blood loss, Cesarean delivery

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Lucile Packard Children's Hospital, Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oxytocin Infusion 1

Oxytocin Infusion 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total Estimated Blood Loss
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

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

Full Information

First Posted
August 21, 2013
Last Updated
December 7, 2016
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01932060
Brief Title
Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.
Official Title
Effects of Different Oxytocin Infusions on Blood Loss and Postpartum Hemoglobin Values in Patients Undergoing Elective Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Oxytocin, blood loss, Cesarean delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin Infusion 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Oxytocin Infusion 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin Infusion
Other Intervention Name(s)
Oxytocin; Pitocin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Estimated Blood Loss
Description
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).
Time Frame
immediately at end of surgery
Secondary Outcome Measure Information:
Title
Hemoglobin Indices After Cesarean Delivery
Description
Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery
Time Frame
24 hr after cesarean delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander J Butwick, F.R.C.A.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucile Packard Children's Hospital, Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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