Oxytocin Via Intramuscular Injection and Intravenous Bolus or Infusion for Prevention of Postpartum Hemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

Administration of Oxytocin Via Intramuscular Injection and Intravenous Bolus or Intravenous Infusion in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914419
• Other study ID #: 3000a
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: March 10, 2016
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage compared to intramuscular (IM) injection.

Description:

The study will compare the effect of IV infusion or IV bolus to IM oxytocin administration with respect to mean blood loss and the proportion of women who experience blood loss greater than or equal to 500 ml, women who experience blood loss greater than or equal to 350 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4983
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• All women who present in active labor for a live birth at the study hospital will be considered for participation in the study

Exclusion Criteria:

• Planned or transferred for delivery via Cesarean section

• Administration of a pre-delivery uterotonic to induce or augment labor

• Unable to provide informed consent due to mental impairment, distress during labor or other reason

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Oxytocin

Locations

Country	Name	City	State
Egypt	Shatby Maternity Hospital, Alexandria University	Alexandria
Egypt	El Galaa Teaching Hospital	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Gynuity Health Projects	El Galaa Teaching Hospital, Faculty of Medicine, University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women with postpartum blood loss equal to or greater than 500 mL	Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.	1 hour after delivery of baby	No
Secondary	Mean postpartum blood loss	Mean blood loss as measured in a plastic, calibrated container.	1 hour after delivery of the baby	No
Secondary	Proportion of women with postpartum blood loss equal to or greater than 350 mL	Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.	1 hour after delivery of the baby	No
Secondary	Proportion of women with postpartum blood loss equal to or greater than 1000 mL	Postpartum blood loss equal to or greater than 1000 mL as measured in a plastic, calibrated container.	1 hour after delivery	No
Secondary	Mean change in hemoglobin pre-delivery to postpartum	Hemoglobin will be measured in g/dL using the Hemocue machine. Pre-delivery hemoglobin will be taken during labor.	At least 12 hours after removal of IV and within 48 hours of delivery of the baby	No
Secondary	Time to delivery of placenta	Time interval in minutes between delivery of the baby and delivery of the placenta	Within 1 hour of delivery of the baby	No
Secondary	Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy		Within 1 hour of delivery of the baby	No
Secondary	Side effects 1 hour postpartum		1 hour after delivery of the baby	No