Intravenous and Intramuscular Administration of Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Intravenous and Intramuscular Administration of Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage|
- Mean blood loss (ml) [ Time Frame: minimum of 1 hour after delivery of baby ] [ Designated as safety issue: No ]
- Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml [ Designated as safety issue: No ]
- Change in hemoglobin from pre-delivery to postpartum [ Time Frame: 12-24 hours after delivery ] [ Designated as safety issue: No ]Post-delivery hemoglobin using a Hemocue® Hemoglobin machine + cuvette will be taken at least 24 after delivery and before the woman leaves the facility. If the woman has received IV fluids, hemoglobin will be measured at least 12 hours after removal of the IV prior to discharge.
- Time to placental delivery [ Designated as safety issue: No ]
- Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy [ Designated as safety issue: No ]
- Side effects 1 hour postpartum [ Time Frame: 1 hour postpartum ] [ Designated as safety issue: No ]
- Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: IV infusion
Oxytocin 10 IU will be administered IV infusion according to randomization assignment as soon as possible after delivery of the baby.
10 IU oxytocin in 500 ml infusion
Active Comparator: IM Injection
Oxytocin 10 IU will be administered IM according to randomization assignment as soon as possible after delivery of the baby.
10 IU oxytocin IM injection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608958
|Hospital Gineco-Obstétrico Isidro Ayora|
|SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi|
|Huong Vuong Hospital|
|Ho Chi Minh City, Vietnam|
|Principal Investigator:||Beverly Winikoff, MD, MPH||Gynuity Health Projects|
|Principal Investigator:||Ilana Dzuba, MHS||Gynuity Health Projects|
|Principal Investigator:||Jill Durocher||Gynuity Health Projects|
|Principal Investigator:||Jennifer Blum, MPH||Gynuity Health Projects|