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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01932060 (opens ClinicalTrials.gov in a new tab)Other id28015
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
51 participants (actual)
Sponsor
Stanford University · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Aug 2013
Primary completion
Sept 2015
Completion
Sept 2015
First posted
30 Aug 2013 (estimated)
Last update posted
1 Feb 2017 (estimated)
Conditions
Postpartum Hemorrhage

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 3

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

    NCT01932060

    Aug 2013 to Sept 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Oxytocin InfusionDrug

Arms2

  • Experimental

    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.

  • Active comparator

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Total Estimated Blood Loss

    Time frame · immediately at end of surgery

    Registry 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).

Secondary outcomes(1)

  1. Hemoglobin Indices After Cesarean Delivery

    Time frame · 24 hr after cesarean delivery

    Registry description

    Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· immediately at end of surgery

Total Estimated Blood Loss

GroupValue (ml)
Oxytocin Infusion 1512
Oxytocin Infusion 2634
Secondary and other outcome results(1)
Secondary outcomeMedian· 24 hr after cesarean delivery

Hemoglobin Indices After Cesarean Delivery

GroupValue (g/dl)
Oxytocin Infusion 111.
Oxytocin Infusion 211.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oxytocin Infusion 1Oxytocin 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: 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.–0 / 270 / 27
Oxytocin Infusion 2Oxytocin 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: 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.–0 / 240 / 24

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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