NCT01954186

Brief Summary

To compare the efficacy of the route and timing of oxytocin administration for Active management of third stage of labour (AMTSL).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

9 months

First QC Date

September 22, 2013

Last Update Submit

September 26, 2013

Conditions

Postpartum Bleeding

Keywords

OxytocinActive Management of Third Stage of Labour

Outcome Measures

Primary Outcomes (1)

  • postpartum bleeding in the third stage of labour

    participants will be followed for the duration of hospital stay, an expected average of 48 hours

Study Arms (2)

intravenous & intramuscular oxytocin

EXPERIMENTAL

intravenous or intramuscular 10 iu oxytocin

Procedure: after delivery of the fetus & when anterior shoulder seen

after delivery & when anterior shoulder seen

ACTIVE COMPARATOR

oxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered

Drug: intravenous & intramuscular oxytocin

Interventions

intravenous & intramuscular oxytocinDRUG

intravenous or intramuscular 10 iu oxytocin

Also known as: Postuitrin
after delivery & when anterior shoulder seen
after delivery of the fetus & when anterior shoulder seenPROCEDURE

oxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered

intravenous & intramuscular oxytocin

Eligibility Criteria

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

You may qualify if:

  • having a singleton pregnancy above 37th gestational week
  • normal live vaginal delivery with cephalic presentation
  • being in active labor

You may not qualify if:

  • Fetal demise
  • multiple pregnancy
  • known coagulation disorder
  • presentation anomalies
  • placental pathology
  • liver disease
  • thrombocytopenia
  • hypertension or being currently on anticoagulants
  • having a cesarean section, operative delivery or deep vaginal tear
  • chorioamnionitis
  • developing HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count) or DIC (disseminated intravascular coagulation) before delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital

Ankara, Turkey (Türkiye)

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

  • Oguz Orhan E, Dilbaz B, Aksakal SE, Altinbas S, Erkaya S. Prospective randomized trial of oxytocin administration for active management of the third stage of labor. Int J Gynaecol Obstet. 2014 Nov;127(2):175-9. doi: 10.1016/j.ijgo.2014.05.022. Epub 2014 Jul 17.

    PMID: 25108586DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

  • Berna DILBAZ, Assoc. Prof.

    Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, Turkey ,

    STUDY DIRECTOR

  • Emire OGUZ ORHAN, MD

    Sivas State Hospital

    STUDY CHAIR

  • Sezin ERTURK AKSAKAL, MD

    Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, Turkey

    PRINCIPAL INVESTIGATOR

  • Sibel ALTINBAS, Assist. Prof.

    Hacettepe University Kastamonu Medical Faculty, Obstetrics and Gynecology, Ankara, Turkey,

    STUDY CHAIR

  • Salim ERKAYA, Assoc. Prof.

    Zekai Tahir Burak Maternity and Teaching Hospital, Obstetrics and Gynecology, Ankara, Turkey

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
UNKNOWN
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
gynecologist and obstetrician

Study Record Dates

First Submitted

September 22, 2013

First Posted

October 1, 2013

Study Start

January 1, 2010

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

TU(1)