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Oxytocin to Decrease Blood Loss During Cesarean Section

NCT00891150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-03-06

No results posted yet for this study

Summary

The goal of this study is to determine the best dose of a drug called oxytocin, that is usually used to stop bleeding during a delivery, when used during a cesarean delivery. It will be administered during cesarean section in order to decrease the amount blood loss. The investigators are proposing to have 3 groups of subjects each given a different safe dose of oxytocin and then to assess the effectiveness of each regimens on the amount blood lost during cesarean sections.This will let use know which is the best lowest dose needed.

Conditions

  • Complications; Cesarean Section

Interventions

DRUG

Oxytocin

Pre-mixed, oxytocin solutions with either 20U/500ml, 30U/500ml or 40U/500ml of Lactated Ringer's solution will be available in the pharmacy department. The bags will be identical in appearance. Each bag will be labeled with a study identification number, from which the pharmacy could determine the administered dose. Subjects as well as the medical providers will be blinded to the assignment of the solution used. Immediately after delivery of the infant, the study solution will be infused over 30 minutes using a continuous infusion pump (666 mU/min versus 999 mU/min versus 1332mU/min).

Sponsors & Collaborators

  • American University of Beirut Medical Center

    lead OTHER

Principal Investigators

  • Labib M Ghulmiyyah, MD · American University of Beirut Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Lebanon

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 NCT00891150 on ClinicalTrials.gov