NCT00891150

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
3.2 years until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

7 months

First QC Date

April 30, 2009

Last Update Submit

March 5, 2013

Conditions

Complications; Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • The change in hemoglobin as a measure of blood loss. The change in hemoglobin is defined as the difference between the predelivery hemoglobin value and the postpartum value

    1 year

Secondary Outcomes (1)

  • The need for blood transfusion and the use of additional uterotonic agents, pad weight, pad count, estimated blood loss.

    1 year

Study Arms (3)

oxytocin

ACTIVE COMPARATOR

group 1 will receive oxytocin solutions with 20U/500ml during cesarean section

Drug: Oxytocin

oxytocin2

ACTIVE COMPARATOR

group 2 will receive oxytocin solutions with 30U/500ml during cesarean section

Drug: Oxytocin

oxytocin3

ACTIVE COMPARATOR

group 3 will receive oxytocin solutions with 40U/500ml during cesarean section

Drug: Oxytocin

Interventions

OxytocinDRUG

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).

Also known as: Pitocin
oxytocinoxytocin2oxytocin3

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Study subjects will be women delivering via an elective cesarean section at term
  • All study subjects will have singleton gestation with no obstetric or medical complication.

You may not qualify if:

  • Laboring women
  • Multifetal gestation
  • Prolonged oxytocin use (\>12 hours)
  • Hypertensive disorders
  • Chorioamnionitis
  • Suspected macrosomia
  • Polyhydramnios
  • History of postpartum Hemorrhage
  • Clotting disorder
  • Intake of magnesium sulfate
  • Uterine fibroids
  • Placenta previa
  • Placental abruption
  • Anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

Related Publications (1)

  • Ghulmiyyah LM, Usta IM, Ghazeeri G, Taher N, Abu-Ghannam G, Tamim H, Nassar AH. Intravenous Oxytocin Use to Decrease Blood Loss during Scheduled Cesarean Delivery: A Randomized Double-Blinded Controlled Trial (OXYTRIAL). Am J Perinatol. 2017 Mar;34(4):379-387. doi: 10.1055/s-0036-1592130. Epub 2016 Sep 2.

    PMID: 27588932DERIVED

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Labib M Ghulmiyyah, MD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 1, 2009

Study Start

July 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

LE(1)