NCT02080104

Brief Summary

Intramuscular versus intravenous prophylactic oxytocin for the third stage of labour following vaginal delivery: A randomised controlled trial

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

1 year

First QC Date

March 1, 2014

Last Update Submit

March 4, 2014

Conditions

Postpartum Hemorrhage

Keywords

postpartum hemorrhageoxytocinvaginal deliveryprophylactic

Outcome Measures

Primary Outcomes (1)

  • early postpartum hemorrhage

    Blood loss during the birth and postpartum hemorrhage asset (within 24 hours\> 500 cc blood loss)

    postpartum 24 hours

Secondary Outcomes (1)

  • Blood transfusion requirement

    postpartum 24 hours

Study Arms (2)

intravenous 10 ıu oxytocin

ACTIVE COMPARATOR

group which 2 ampul prophylactic oxytocin given for third stage of labour intravenously after vaginal delivery

Drug: intarvenous and intramusculer 10 IU oxytocin

intramusculer 10 ıu oxytocin

EXPERIMENTAL

group which oxytocin administered intramusculary after vaginal delivery

Drug: intarvenous and intramusculer 10 IU oxytocin

Interventions

intarvenous and intramusculer 10 IU oxytocinDRUG

intarvenous and intramusculer 10 IU oxytocin

intramusculer 10 ıu oxytocinintravenous 10 ıu oxytocin

Eligibility Criteria

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

You may qualify if:

  • Research volunteers, the undersigned, pregnant women
  • Only with vaginal delivery (episiotomy and perineal tears can)
  • \> 34 weeks or more will be
  • Cephalic presentation will be
  • At low risk of postpartum hemorrhage

You may not qualify if:

  • \<18 years
  • Multiple pregnancies
  • The presence of uterine myoma
  • Having postpartum hemorrhage in previous pregnancies
  • Placenta previa, polyhydramnios
  • More than four parity
  • Fetal macrosomia
  • Hb \<9mg/dl
  • preeclampsia
  • Uterine anomalies
  • Receiving anticoagulant therapy, suspected coagulopathy
  • \> 42 weeks of pregnancy
  • Oxytocin allergy -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırkoy Dr Sadi Konuk Teaching and Research Hospital

Istanbul, 34140, Turkey (Türkiye)

RECRUITING

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

Central Study Contacts

nurten kayacan aydemir

CONTACT

2124147171nurten.aydemir@beah.gov.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

March 1, 2014

First Posted

March 6, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations

TU(1)