Intramuscular Versus Intravenous Prophylactic Oxytocin for Hemorrhage After Vaginal Delivery (oxytocin)

March 4, 2014 updated by: Hediye Dagdeviren

Intramuscular Versus Intravenous Prophylactic Oxytocin for the Third Stage of Labour Following Vaginal Delivery: A Randomised Controlled Trial

Intramuscular versus intravenous prophylactic oxytocin for the third stage of labour following vaginal delivery: A randomised controlled trial

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Prevention of postpartum haemorrhage is essential in the pursuit of improved health care for women. In this study investigators aimed to compare intramuscular oxytocin with intravenous oxytocin for the routine prevention of postpartum haemorrhage in women who deliver vaginally.In some countries, intravenous access can not be provided easily . Intramuscular application is faster , easier and tougher enforcement requires less skill and equipment . For this reason, less educated , which can be applied by those offering health services .

Study Type

Interventional

Enrollment (Anticipated)

2

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 Locations

  • Turkey
      • Istanbul, Turkey, 34140
        • Recruiting
        • Bakırkoy Dr Sadi Konuk 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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Research volunteers, the undersigned, pregnant women
  2. Only with vaginal delivery (episiotomy and perineal tears can)
  3. > 34 weeks or more will be
  4. Cephalic presentation will be
  5. At low risk of postpartum hemorrhage

Exclusion Criteria:

  1. <18 years
  2. Multiple pregnancies
  3. The presence of uterine myoma
  4. Having postpartum hemorrhage in previous pregnancies
  5. Placenta previa, polyhydramnios
  6. More than four parity
  7. Fetal macrosomia
  8. Hb <9mg/dl
  9. preeclampsia
  10. Uterine anomalies
  11. Receiving anticoagulant therapy, suspected coagulopathy
  12. > 42 weeks of pregnancy
  13. Oxytocin allergy -

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intravenous 10 ıu oxytocin
group which 2 ampul prophylactic oxytocin given for third stage of labour intravenously after vaginal delivery
Drug: intarvenous and intramusculer 10 IU oxytocin
intarvenous and intramusculer 10 IU oxytocin
Experimental: intramusculer 10 ıu oxytocin
group which oxytocin administered intramusculary after vaginal delivery
Drug: intarvenous and intramusculer 10 IU oxytocin
intarvenous and intramusculer 10 IU oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early postpartum hemorrhage
Time Frame: postpartum 24 hours
Blood loss during the birth and postpartum hemorrhage asset (within 24 hours> 500 cc blood loss)
postpartum 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood transfusion requirement
Time Frame: postpartum 24 hours
  • Blood transfusion requirement
  • duration of phase 3 (> 30 min)
  • necessity of additional treatments for postpartum hemorrhage
  • the necessity of manual removal of placenta
  • side effects of the
postpartum 24 hours

Collaborators and Investigators

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

Sponsor

Hediye Dagdeviren

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

February 1, 2014

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

March 1, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Estimate)

March 6, 2014

Last Update Submitted That Met QC Criteria

March 4, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27-01.14-02-02

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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