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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor:
Information provided by (Responsible Party):
Hediye Dagdeviren, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT02080104
First received: March 1, 2014
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Postpartum Hemorrhage
Drug: intarvenous and intramusculer 10 IU oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intramuscular Versus Intravenous Prophylactic Oxytocin for the Third Stage of Labour Following Vaginal Delivery: A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:

Primary Outcome Measures:
  • early postpartum hemorrhage [ Time Frame: postpartum 24 hours ] [ Designated as safety issue: No ]
    Blood loss during the birth and postpartum hemorrhage asset (within 24 hours> 500 cc blood loss)


Secondary Outcome Measures:
  • Blood transfusion requirement [ Time Frame: postpartum 24 hours ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 2
Study Start Date: February 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 .

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02080104

Contacts
Contact: nurten kayacan aydemir 2124147171 ext 7372 nurten.aydemir@beah.gov.tr

Locations
Turkey
Bakırkoy Dr Sadi Konuk Teaching and Research Hospital Recruiting
Istanbul, Turkey, 34140
Contact: hediye dağdeviren , md    2124147171 ext 7372    hediyedagdeviren@gmail.com   
Principal Investigator: hüseyin cengiz, md         
Sponsors and Collaborators
Hediye Dagdeviren
  More Information

No publications provided

Responsible Party: Hediye Dagdeviren, md, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT02080104     History of Changes
Other Study ID Numbers: 27-01.14-02-02
Study First Received: March 1, 2014
Last Updated: March 4, 2014
Health Authority: Turkey: Ministry of Health

Keywords provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:
postpartum hemorrhage
oxytocin
vaginal delivery
prophylactic

Additional relevant MeSH terms:
Obstetric Labor Complications
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014