Postpartum Hemorrhage
Conditions
Keywords
Postpartum hemorrhage, Oxytocin, Third stage of labor, Hemoglobin, Prevention, Intravenous, Intramuscular
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.
Interventions
DRUGOxytocin
10 IU oxytocin in 500 ml infusion
Sponsors
Center for Research and Consultancy in Reproductive Health
Huong Vuong Hospital
MOH Etlik Zubeyde Hanim Women's Health Training and Research Hospital
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean blood loss (ml) | minimum of 1 hour after delivery of baby |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin from pre-delivery to postpartum | 12-24 hours after delivery | 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 | minimum of 1 hour after delivery of baby | — |
| Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml | minimum of 1 hour after delivery of baby | — |
| Side effects 1 hour postpartum | 1 hour postpartum | — |
| Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward | arrival to labor ward | — |
| Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy | minimum of 1 hour after delivery of baby | — |
Countries
Ecuador, Turkey (Türkiye), Vietnam
Outcome results
None listed