Intramuscular Versus Intravenous Prophylactic Oxytocin for Hemorrhage After Vaginal Delivery

Postpartum Hemorrhage Clinical Trial

— oxytocin  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02080104
• Other study ID #: 27-01.14-02-02
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2014
• Last updated: March 4, 2014
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2014
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: nurten kayacan aydemir
• Phone: 2124147171
• Email: nurten.aydemir[@]beah.gov.tr
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• intarvenous and intramusculer 10 IU oxytocin
intarvenous and intramusculer 10 IU oxytocin

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr Sadi Konuk Teaching and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Hediye Dagdeviren

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early postpartum hemorrhage	Blood loss during the birth and postpartum hemorrhage asset (within 24 hours> 500 cc blood loss)	postpartum 24 hours	No
Secondary	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	postpartum 24 hours	No