Intramuscular Versus Intravenous Prophylactic Oxytocin for Hemorrhage After Vaginal Delivery

Not Applicable

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: intarvenous and intramusculer 10 IU oxytocin

• Registration Number: NCT02080104
• Lead Sponsor: Hediye Dagdeviren

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 .

Study Timeline

• Study Start: 2014-02
• Status Verified: 2014-03
• Study First Submitted: 2014-03-01
• Study First Submitted QC: 2014-03-04
• Last Update Submitted: 2014-03-04
• Study First Posted: 2014-03-06
• Last Update Posted: 2014-03-06
• Primary Completion: 2015-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intramusculer 10 ıu oxytocin	intarvenous and intramusculer 10 IU oxytocin	group which oxytocin administered intramusculary after vaginal delivery
intravenous 10 ıu oxytocin	intarvenous and intramusculer 10 IU oxytocin	group which 2 ampul prophylactic oxytocin given for third stage of labour intravenously after vaginal delivery

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood transfusion requirement	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

Trial Locations

Locations (1)

Bakırkoy Dr Sadi Konuk Teaching and Research Hospital; 🇹🇷 Istanbul, Turkey