NCT02495272

Brief Summary

The investigators are planning to determine the effect of the timing of oxytocin administration on the amount of blood loss, necessity for additional medical or surgical interventions.

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
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 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

June 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

July 13, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

April 9, 2015

Last Update Submit

July 8, 2015

Conditions

Postpartum Bleeding

Keywords

Postpartum hemorrhageThird stage of labourOxytocinUterotonicsActive management of third stage of labour

Outcome Measures

Primary Outcomes (2)

  • Postpartum blood loss

    Quantitative collection of blood loss.

    Participants will be followed for the duration of hospital stay, an expected average of 24 hour

  • Postpartum blood loss >500cc

    Number of participants whose blood loss is higher than 500cc.

    Participants will be followed for the duration of hospital stay, an expected average of 24 hour

Secondary Outcomes (5)

  • Need for additional uterotonics

    Participants will be followed for the duration of hospital stay, an expected average of 24 hour

  • Postpartum transfusion

    Participants will be followed for the duration of hospital stay, an expected average of 24 hour.

  • Manual removal of the placenta.

    At first hour after delivery of the fetus

  • Duration of the third stage of labour.

    Participants will be followed for the duration of labor unit stay, an expected average of one hour

  • Drop in the hemoglobin and hematocrit levels

    At the 24th hour,postpartum

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Oxytocin 10IU im was administered after placental delivery

Drug: Oxytocin

Study Group

EXPERIMENTAL

Oxytocin 10IU im was administered after the anterior shoulder could be seen.

Drug: Oxytocin

Interventions

OxytocinDRUG

Oxytocin 10IU Administered intramuscularly.

Also known as: PostuitrinFort Amp I.E.Ulagay
Control GroupStudy Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Cephalic presentation
  • Singleton pregnancy
  • Gestational age \>35 weeks,
  • In active labour.
  • Expected fetal birth weight 2500-4500 grams.

You may not qualify if:

  • Acute Fetal Distress
  • Conversion to abdominal delivery
  • Persistent high blood pressure (\>140/90mmHg)
  • Placenta Previa
  • Ablatio placenta
  • Previous C-Section
  • Uterine scar
  • Postpartum hemorrhage in previous pregnancies.
  • Hydramnios
  • Maternal infection
  • Forceps/Vacuum Assisted deliveries
  • Abnormal placentation ( Placenta accreta, increta or percreta)
  • Coagulation Defects
  • Hemoglobin \< 8g/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Teaching and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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: 25108586BACKGROUND

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

  • Burak Ozkose, MD

    Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul

    STUDY CHAIR

  • Dogukan Yildirim, MD

    Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul

    PRINCIPAL INVESTIGATOR

  • Eser S Ozyurek, MD

    Bagcilar Training and Research Hospital

    STUDY CHAIR

  • Batuhan Ustun, MD

    Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul

    STUDY CHAIR

Central Study Contacts

Dogukan Yildirim, MD

CONTACT

+905063284383dogukanyildirim@yahoo.com

Eser S Ozyurek, MD

CONTACT

+905309322345eozyurek@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 9, 2015

First Posted

July 13, 2015

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

July 13, 2015

Record last verified: 2015-07

Locations

TU(1)