Clinical trial NCT01608958: IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage
Official title: Intravenous and Intramuscular Administration of Oxytocin 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
Third stage of labor
Hemoglobin
Prevention
Intravenous
Intramuscular
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Center for Research and Consultancy in Reproductive Health
name: Huong Vuong Hospital
name: MOH Etlik Zubeyde Hanim Women's Health Training and Research Hospital
First posted: 2012-05-31
Enrollment: 653
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.

Detailed description: The study will compare the effect of IV infusion and IM oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. It will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.

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: Women who are:

* Planned or transferred for delivery via Cesarean section
* Not delivering a live birth
* Unable to provide informed consent due to mental impairment, distress during labor or other reason
* Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.

Primary outcomes:
measure: Mean blood loss (ml)
timeFrame: minimum of 1 hour after delivery of baby
Secondary outcomes:
measure: Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml
timeFrame: minimum of 1 hour after delivery of baby
measure: Change in hemoglobin from pre-delivery to postpartum
timeFrame: 12-24 hours after delivery
measure: Time to placental delivery
timeFrame: minimum of 1 hour after delivery of baby
measure: Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy
timeFrame: minimum of 1 hour after delivery of baby
measure: Side effects 1 hour postpartum
timeFrame: 1 hour postpartum
measure: Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward
timeFrame: arrival to labor ward
Other outcomes:
Locations:
city: Quito
country: Ecuador
facility: Hospital Gineco-Obstétrico Isidro Ayora
city: Ankara
country: Turkey
facility: SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi
city: Ho Chi Minh City
country: Vietnam
facility: Huong Vuong Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, 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: Jennifer Blum, 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.