Postpartum Uterotonic Administration

July 8, 2015 updated by: Eser Sefik Ozyurek, Bagcilar Training and Research Hospital

The Effect of the Timing of Uterotonic Administration in the Third Stage of Labour on Postpartum Hemorrhage

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators are studying the effects of the timing of intramuscular oxytocin administration in the third stage of labour. The investigators are measuring the postpartum blood loss: quantitatively in the postpartum 1st hour and indirectly by the decrease in the hemoglobin-haematocrit levels in the postpartum 24th hour. The investigators are monitoring the length of the third stage of labour, and the need for extra uterotonics and/or surgical interventions.

Study Type

Interventional

Enrollment (Anticipated)

330

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 Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34303
        • Recruiting
        • Kanuni Sultan Suleyman Teaching and Research Hospital
        • Contact:

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Oxytocin 10IU im was administered after placental delivery
Drug: Oxytocin
Oxytocin 10IU Administered intramuscularly.
Other Names:
  • PostuitrinFort Amp I.E.Ulagay
Experimental: Study Group
Oxytocin 10IU im was administered after the anterior shoulder could be seen.
Drug: Oxytocin
Oxytocin 10IU Administered intramuscularly.
Other Names:
  • PostuitrinFort Amp I.E.Ulagay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum blood loss
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour
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
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for additional uterotonics
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour
Additional uterotonics (Oxytocin 10IU; Cytotec tb Rectal and/or vaginal) were administered if postpartum blood loss >500ml OR uterine atony was observed OR sudden excessive hemorrhage was encountered.
Participants will be followed for the duration of hospital stay, an expected average of 24 hour
Postpartum transfusion
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour.
Participants will be followed for the duration of hospital stay, an expected average of 24 hour.
Manual removal of the placenta.
Time Frame: At first hour after delivery of the fetus
At first hour after delivery of the fetus
Duration of the third stage of labour.
Time Frame: Participants will be followed for the duration of labor unit stay, an expected average of one hour
Participants will be followed for the duration of labor unit stay, an expected average of one hour
Drop in the hemoglobin and hematocrit levels
Time Frame: At the 24th hour,postpartum
At the 24th hour,postpartum

Collaborators and Investigators

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

Sponsor

Bagcilar Training and Research Hospital

Collaborators

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Study Chair: Burak Ozkose, MD, Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul
  • Principal Investigator: Dogukan Yildirim, MD, Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul
  • Study Chair: Eser S Ozyurek, MD, Bagcilar Training and Research Hospital
  • Study Chair: Batuhan Ustun, MD, Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul

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

June 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (Estimate)

July 13, 2015

Study Record Updates

Last Update Posted (Estimate)

July 13, 2015

Last Update Submitted That Met QC Criteria

July 8, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kanuni-Bagcilar

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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