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

September 26, 2013 updated by: SEZİN ERTURK AKSAKAL, Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
To compare the efficacy of the route and timing of oxytocin administration for Active management of third stage of labour (AMTSL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intravenous & intramuscular oxytocin
intravenous or intramuscular 10 iu oxytocin
Procedure: after 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
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
intravenous or intramuscular 10 iu oxytocin
Other Names:
  • Postuitrin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Investigators

  • Study Director: Berna DILBAZ, Assoc. Prof., Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, Turkey ,
  • Study Chair: Emire OGUZ ORHAN, MD, Sivas State Hospital
  • Principal Investigator: Sezin ERTURK AKSAKAL, MD, Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, Turkey
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 22, 2013

First Submitted That Met QC Criteria

September 26, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Estimate)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 26, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EtlikWHTH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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