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CompletedNCT01954186Updated Oct 1, 2013

When and How to Administer Oxytocin for Active Management of Third Stage of Labour

An interventional study of intravenous & intramuscular oxytocin and after delivery of the fetus & when anterior shoulder seen in Postpartum Bleeding, sponsored by Etlik Zubeyde Hanim Womens' Health and Teaching Hospital. Completed at 1 site in Turkey. Open to female participants. Per ClinicalTrials.gov, last updated 2013-10-01.

Sponsored by Etlik Zubeyde Hanim Womens' Health and Teaching Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Sex
Female
01

Study summary

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

Read the detailed description

Our objective is to determine the most efficient route and timing of oxytocin administration by measuring the duration of third stage of labour, quantitative blood during the first hour after delivery and comparing haemoglobin and haematocrit changes and the need for additional interventions in patients who had either a spontaneous labour or received labour augmentation with oxytocin.

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Conditions studied

  • Postpartum Bleeding

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Keywords

  • Oxytocin
  • Active Management of Third Stage of Labour
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In context

Postpartum Hemorrhage

445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.

This study's enrollment of 600 is above the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
600 participants (actual)

Study arms

  • Experimental
    intravenous & intramuscular oxytocin

    intravenous or intramuscular 10 iu oxytocin

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

  • Active comparator
    after delivery & when anterior shoulder seen

    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

  • Drugintravenous & intramuscular oxytocin

    intravenous or intramuscular 10 iu oxytocin

    Also known as: Postuitrin

  • Procedureafter delivery of the fetus & when anterior shoulder seen

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

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What researchers measure

Primary outcomes

  1. postpartum bleeding in the third stage of labour

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

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Study locations

1 site
  • Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital
    Ankara, Turkey
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References and documents

Publications

  • 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. PubMed 33169839 ↗
  • 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. PubMed 25108586 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01954186
Lead sponsor
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
Responsible party
SEZİN ERTURK AKSAKAL (gynecologist and obstetrician, Etlik Zubeyde Hanim Womens' Health and Teaching Hospital) — Principal investigator
First posted
Oct 1, 2013
Start date
Jan 2010
Primary completion
Oct 2010
Completion
Dec 2010
Last update
Oct 1, 2013

Study contacts

Berna DILBAZ, Assoc. Prof.
study director · Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, Turkey ,
Emire OGUZ ORHAN, MD
study chair · Sivas State Hospital
Sezin ERTURK AKSAKAL, MD
principal investigator · Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, Turkey
Sibel ALTINBAS, Assist. Prof.
study chair · Hacettepe University Kastamonu Medical Faculty, Obstetrics and Gynecology, Ankara, Turkey,
Salim ERKAYA, Assoc. Prof.
study chair · Zekai Tahir Burak Maternity and Teaching Hospital, Obstetrics and Gynecology, Ankara, Turkey

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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