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Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress

NCT01869556 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-09-24

No results posted yet for this study

Summary

Patients having Cesarean section after they have been in labor for many hours bleed much more, in average twice as much, as compared with patients having an elective Cesarean section. The investigators believe a simple change in practice might contribute to reduce this bleeding. This study will involve the use of oxytocin (also known as syntocinon), ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given through the intravenous line, while carboprost is given as an injection in the muscle. Although they are not routinely given in every case, these are very frequently given as rescue medications to patients who fail to respond appropriately to oxytocin. This study is designed to determine if ergonovine or carboprost given in association with oxytocin, in a preventive way, after delivery of the baby and placenta, can reduce the amount of blood loss during Cesarean sections following a trial of labour.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Oxytocin

Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours

DRUG

Ergot

Ergot 0.25mg IV

DRUG

Carboprost

Carboprost 0.25mg IM

Sponsors & Collaborators

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    lead OTHER

Principal Investigators

  • Mrinalini Balki, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-04
Primary Completion
2019-07-08
Completion
2019-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01869556 on ClinicalTrials.gov