Postpartum Hemorrhage
Conditions
Keywords
Oxytocin
Brief summary
This double-blind, randomized controlled trial will evaluate the effect of the route of administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection IM
Interventions
DRUGIV Oxytocin + IM placebo
DRUGIM Oxytocin + IV placebo
Sponsors
Centro Rosarino de Estudios Perinatales (CREP)
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* She is present to give birth to a live fetus * Vaginal delivery * Willing to participate in the study * Able to give informed consent
Exclusion criteria
* Scheduled for a cesarean * Reject the placement of an IV during labor (for intravenous infusion) * Cannot give informed consent for any reason * Not willing and / or cannot answer questions about background
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of blood loss (mL) | 1 hour postpartum |
| Proportion of women who had postpartum blood loss ≥500 ml | 1 hour postpartum |
Secondary
| Measure | Time frame |
|---|---|
| Average time required until expulsion of the placenta | 1 hour postpartum |
| Proportion who needed additional Interventions | Through study completion, an average of 24-48 hours postpartum |
| Proportion of women who had postpartum blood loss ≥1000 ml | 1 hour postpartum |
| Blood pressure | 15, 30, 45 and 60 minutes postpartum |
| Heart rate | 15, 30, 45 and 60 minutes postpartum |
| Side effects | 1 hour postpartum |
| Average change in hemoglobin level | pre-delivery and at least 24 hours postpartum |
Countries
Argentina
Outcome results
None listed