NCT01608958

Brief Summary

The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
653

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

Geographic Reach
3 countries

3 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

Study Start

First participant enrolled

May 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 28, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

May 29, 2012

Last Update Submit

March 25, 2016

Conditions

Postpartum Hemorrhage

Keywords

Postpartum hemorrhageOxytocinThird stage of laborHemoglobinPreventionIntravenousIntramuscular

Outcome Measures

Primary Outcomes (1)

  • Mean blood loss (ml)

    minimum of 1 hour after delivery of baby

Secondary Outcomes (6)

  • Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml

    minimum of 1 hour after delivery of baby

  • Change in hemoglobin from pre-delivery to postpartum

    12-24 hours after delivery

  • Time to placental delivery

    minimum of 1 hour after delivery of baby

  • Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy

    minimum of 1 hour after delivery of baby

  • Side effects 1 hour postpartum

    1 hour postpartum

  • +1 more secondary outcomes

Study Arms (2)

IV infusion

ACTIVE COMPARATOR

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

Drug: Oxytocin

Interventions

OxytocinDRUG

10 IU oxytocin in 500 ml infusion

IV infusion

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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
  • Not delivering a live birth
  • Unable to provide informed consent due to mental impairment, distress during labor or other reason
  • Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Gineco-Obstétrico Isidro Ayora

Quito, Ecuador

Location

SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi

Ankara, Turkey (Türkiye)

Location

Huong Vuong Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

  • 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

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

  • Ilana Dzuba, MHS

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Jill Durocher

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Jennifer Blum, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 29, 2012

First Posted

May 31, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

March 28, 2016

Record last verified: 2016-03

Locations

VN(1)TU(1)EC(1)