Clinical trial NCT01914419: Oxytocin Via Intramuscular Injection and Intravenous Bolus or Infusion for Prevention of Postpartum Hemorrhage
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: Postpartum hemorrhage
Oxytocin
Prevention
Third stage of labor
Hemoglobin
Intravenous
Intramuscular
Bolus
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: El Galaa Teaching Hospital
name: University of Alexandria
First posted: 2013-08-02
Enrollment: 4983
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of women with postpartum blood loss equal to or greater than 500 mL
timeFrame: 1 hour after delivery of baby
Secondary outcomes:
measure: Mean postpartum blood loss
timeFrame: 1 hour after delivery of the baby
measure: Proportion of women with postpartum blood loss equal to or greater than 350 mL
timeFrame: 1 hour after delivery of the baby
measure: Proportion of women with postpartum blood loss equal to or greater than 1000 mL
timeFrame: 1 hour after delivery
measure: Mean change in hemoglobin pre-delivery to postpartum
timeFrame: At least 12 hours after removal of IV and within 48 hours of delivery of the baby
measure: Time to delivery of placenta
timeFrame: Within 1 hour of delivery of the baby
measure: Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy
timeFrame: Within 1 hour of delivery of the baby
measure: Side effects 1 hour postpartum
timeFrame: 1 hour after delivery of the baby
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Shatby Maternity Hospital, Alexandria University
city: Cairo
country: Egypt
facility: El Galaa Teaching Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Rasha Dabash, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Ilana Dzuba, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Jill Durocher
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Dyanna Charles, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Charles D, Anger H, Dabash R, Darwish E, Ramadan MC, Mansy A, Salem Y, Dzuba IG, Byrne ME, Breebaart M, Winikoff B. Intramuscular injection, intravenous infusion, and intravenous bolus of oxytocin in the third stage of labor for prevention of postpartum hemorrhage: a three-arm randomized control trial. BMC Pregnancy Childbirth. 2019 Jan 18;19(1):38. doi: 10.1186/s12884-019-2181-2.