search
Back to results

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

Primary Purpose

Postpartum Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
intarvenous and intramusculer 10 IU oxytocin
Sponsored by
Hediye Dagdeviren
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring postpartum hemorrhage, oxytocin, vaginal delivery, prophylactic

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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 -

Sites / Locations

  • Bakırkoy Dr Sadi Konuk Teaching and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

intravenous 10 ıu oxytocin

intramusculer 10 ıu oxytocin

Arm Description

group which 2 ampul prophylactic oxytocin given for third stage of labour intravenously after vaginal delivery

group which oxytocin administered intramusculary after vaginal delivery

Outcomes

Primary Outcome Measures

early postpartum hemorrhage
Blood loss during the birth and postpartum hemorrhage asset (within 24 hours> 500 cc blood loss)

Secondary Outcome Measures

Blood transfusion requirement
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

Full Information

First Posted
March 1, 2014
Last Updated
March 4, 2014
Sponsor
Hediye Dagdeviren
search

1. Study Identification

Unique Protocol Identification Number
NCT02080104
Brief Title
Intramuscular Versus Intravenous Prophylactic Oxytocin for Hemorrhage After Vaginal Delivery
Acronym
oxytocin
Official Title
Intramuscular Versus Intravenous Prophylactic Oxytocin for the Third Stage of Labour Following Vaginal Delivery: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hediye Dagdeviren

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
postpartum hemorrhage, oxytocin, vaginal delivery, prophylactic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intravenous 10 ıu oxytocin
Arm Type
Active Comparator
Arm Description
group which 2 ampul prophylactic oxytocin given for third stage of labour intravenously after vaginal delivery
Arm Title
intramusculer 10 ıu oxytocin
Arm Type
Experimental
Arm Description
group which oxytocin administered intramusculary after vaginal delivery
Intervention Type
Drug
Intervention Name(s)
intarvenous and intramusculer 10 IU oxytocin
Intervention Description
intarvenous and intramusculer 10 IU oxytocin
Primary Outcome Measure Information:
Title
early postpartum hemorrhage
Description
Blood loss during the birth and postpartum hemorrhage asset (within 24 hours> 500 cc blood loss)
Time Frame
postpartum 24 hours
Secondary Outcome Measure Information:
Title
Blood transfusion requirement
Description
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
Time Frame
postpartum 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Research volunteers, the undersigned, pregnant women Only with vaginal delivery (episiotomy and perineal tears can) > 34 weeks or more will be Cephalic presentation will be At low risk of postpartum hemorrhage Exclusion Criteria: <18 years Multiple pregnancies The presence of uterine myoma Having postpartum hemorrhage in previous pregnancies Placenta previa, polyhydramnios More than four parity Fetal macrosomia Hb <9mg/dl preeclampsia Uterine anomalies Receiving anticoagulant therapy, suspected coagulopathy > 42 weeks of pregnancy Oxytocin allergy -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nurten kayacan aydemir
Phone
2124147171
Ext
7372
Email
nurten.aydemir@beah.gov.tr
Facility Information:
Facility Name
Bakırkoy Dr Sadi Konuk Teaching and Research Hospital
City
Istanbul
ZIP/Postal Code
34140
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hediye dağdeviren, md
Phone
2124147171
Ext
7372
Email
hediyedagdeviren@gmail.com
First Name & Middle Initial & Last Name & Degree
hüseyin cengiz, md

12. IPD Sharing Statement

Citations:
PubMed Identifier
33169839
Citation
Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.
Results Reference
derived

Learn more about this trial

Intramuscular Versus Intravenous Prophylactic Oxytocin for Hemorrhage After Vaginal Delivery

We'll reach out to this number within 24 hrs