NCT01914419

Brief Summary

The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage compared to intramuscular (IM) injection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,983

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.4 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
Last Updated

March 11, 2016

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

July 31, 2013

Last Update Submit

March 10, 2016

Conditions

Postpartum Hemorrhage

Keywords

Postpartum hemorrhageOxytocinPreventionThird stage of laborHemoglobinIntravenousIntramuscularBolus

Outcome Measures

Primary Outcomes (1)

  • Proportion of women with postpartum blood loss equal to or greater than 500 mL

    Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.

    1 hour after delivery of baby

Secondary Outcomes (7)

  • Mean postpartum blood loss

    1 hour after delivery of the baby

  • Proportion of women with postpartum blood loss equal to or greater than 350 mL

    1 hour after delivery of the baby

  • Proportion of women with postpartum blood loss equal to or greater than 1000 mL

    1 hour after delivery

  • Mean change in hemoglobin pre-delivery to postpartum

    At least 12 hours after removal of IV and within 48 hours of delivery of the baby

  • Time to delivery of placenta

    Within 1 hour of delivery of the baby

  • +2 more secondary outcomes

Study Arms (3)

IV infusion

ACTIVE COMPARATOR

Oxytocin 10 IU will be administered by IV infusion according to randomization assignment as soon as possible after delivery of the baby.

Drug: Oxytocin

IV bolus

ACTIVE COMPARATOR

Oxytocin 10 IU will be administered by IV bolus according to randomization assignment as soon as possible after delivery of the baby.

Drug: Oxytocin

IM injection

ACTIVE COMPARATOR

Oxytocin 10 IU will be administered by IM injection according to randomization assignment as soon as possible after delivery of the baby.

Drug: Oxytocin

Interventions

OxytocinDRUG
IM injectionIV bolusIV infusion

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All women who present in active labor for a live birth at the study hospital will be considered for participation in the study

You may not qualify if:

  • Planned or transferred for delivery via Cesarean section
  • Administration of a pre-delivery uterotonic to induce or augment labor
  • Unable to provide informed consent due to mental impairment, distress during labor or other reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shatby Maternity Hospital, Alexandria University

Alexandria, Egypt

Location

El Galaa Teaching Hospital

Cairo, Egypt

Location

Related Publications (2)

  • Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.

    PMID: 33169839DERIVED

  • Charles D, Anger H, Dabash R, Darwish E, Ramadan MC, Mansy A, Salem Y, Dzuba IG, Byrne ME, Breebaart M, Winikoff B. Intramuscular injection, intravenous infusion, and intravenous bolus of oxytocin in the third stage of labor for prevention of postpartum hemorrhage: a three-arm randomized control trial. BMC Pregnancy Childbirth. 2019 Jan 18;19(1):38. doi: 10.1186/s12884-019-2181-2.

    PMID: 30658605DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Rasha Dabash, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Ilana Dzuba, MHS

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Jill Durocher

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Dyanna Charles, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 2, 2013

Study Start

April 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 11, 2016

Record last verified: 2016-02

Locations

EG(2)