NCT01932060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 1, 2017

Completed
Last Updated

February 1, 2017

Status Verified

December 1, 2016

Enrollment Period

2.1 years

First QC Date

August 21, 2013

Results QC Date

February 3, 2016

Last Update Submit

December 7, 2016

Conditions

Postpartum Hemorrhage

Keywords

Oxytocinblood lossCesarean delivery

Outcome Measures

Primary Outcomes (1)

  • 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).

    immediately at end of surgery

Secondary Outcomes (1)

  • Hemoglobin Indices After Cesarean Delivery

    24 hr after cesarean delivery

Study Arms (2)

Oxytocin Infusion 1

EXPERIMENTAL

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.

Drug: Oxytocin Infusion

Oxytocin Infusion 2

ACTIVE COMPARATOR

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.

Drug: Oxytocin Infusion

Interventions

Oxytocin InfusionDRUG

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.

Also known as: Oxytocin; Pitocin
Oxytocin Infusion 1Oxytocin Infusion 2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Children's Hospital, Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Postpartum HemorrhageHemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr. Alexander Butwick
Organization
Stanford University School of Medicine
ajbut@stanford.edu
(650) 736-8513

Study Officials

  • Alexander J Butwick, F.R.C.A.

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2013

First Posted

August 30, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 1, 2017

Results First Posted

February 1, 2017

Record last verified: 2016-12

Locations

US(1)