Postpartum Hemorrhage
Conditions
Keywords
Third stage of labor
Brief summary
The purpose of this study is to determine if giving oxytocin immediately after delivery causes less bleeding, transfusion needs and hastens delivery of placenta.
Detailed description
Postpartum hemorrhage is the leading cause of maternal mortality worldwide. During the third stage of labor, the period following the delivery of the baby until the delivery of the placenta, the patient is at increased risk for blood loss. Controversy remains as to the optimal method of delivering the placenta. Two predominant, yet very different, strategies have emerged. Expectant management is most commonly used in the United States. This includes waiting for signs of placental separation, followed by maternal pushing to expel the placenta. Then uterotonic agents are administered,usually oxytocin. This is in contrast to active management, which consists of uterotonic administration immediately following delivery of the fetus, in association with gentle umbilical cord traction and fundal massage. This is the predominant practice in the United Kingdom, where the uterotonic agents of choice are either oxytocin alone, or a combination of oxytocin and ergometrine. Comparison: Active management with oxytocin to expectant management of the third stage of labor on the effect of postpartum hemorrhage.
Interventions
standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage
standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun
DRUGOxytocin and gentle cord traction with fundal massage
standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage
DRUGOxytocin
standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun
Sponsors
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Singleton gestation * Cephalic presentation * \>37 weeks gestation * \>16 years of age
Exclusion criteria
* Multiple gestation * Breech presentation * Blood dyscrasias * Multiparous females Para \>5 * Placenta previa * Patients on anticoagulants * Previous history of postpartum hemorrhage * IUFD * Non-reassuring fetal heart rate pattern
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater | reported immediately after delivery |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in hematocrit from before delivery to the first postpartum day | 24 hours |
| Rate of maternal blood transfusion | 48 hours |
| Duration of the third stage of labor | 60 minutes |
| Incidence of retained placenta | 30 minutes |
Countries
United States
Outcome results
None listed