Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT02080104 |
Date of registration:
|
01/03/2014 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Intramuscular Versus Intravenous Prophylactic Oxytocin for Hemorrhage After Vaginal Delivery
oxytocin |
Scientific title:
|
Intramuscular Versus Intravenous Prophylactic Oxytocin for the Third Stage of Labour Following Vaginal Delivery: A Randomised Controlled Trial |
Date of first enrolment:
|
February 2014 |
Target sample size:
|
2 |
Recruitment status: |
Recruiting |
URL:
|
http://clinicaltrials.gov/show/NCT02080104 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Turkey
| | | | | | | |
Contacts
|
Name:
|
nurten kayacan aydemir |
Address:
|
|
Telephone:
|
2124147171 |
Email:
|
nurten.aydemir@beah.gov.tr |
Affiliation:
|
|
|
Name:
|
hediye dagdeviren , md |
Address:
|
|
Telephone:
|
2124147171 |
Email:
|
hediyedagdeviren@gmail.com |
Affiliation:
|
|
| |
Key inclusion & exclusion 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 -
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
|
Health Condition(s) or Problem(s) studied
|
Postpartum Hemorrhage
|
Intervention(s)
|
Drug: intarvenous and intramusculer 10 IU oxytocin
|
Primary Outcome(s)
|
early postpartum hemorrhage
[Time Frame: postpartum 24 hours]
|
Secondary Outcome(s)
|
Blood transfusion requirement
[Time Frame: postpartum 24 hours]
|
Secondary ID(s)
|
27-01.14-02-02
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|