Bleed Pregnancy, Blood Loss, Surgical, Cesarean Section Complications, Postpartum Hemorrhage, Pregnancy Related
Conditions
Brief summary
This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss. Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta. We hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.
Detailed description
Oxytocin is a routinely administered medication for both vaginal and cesarean deliveries in the third stage of labor, as part of standard of care in the United States. This medication helps to reduce overall blood loss, by functioning as a uterotonic. Currently evidence is lacking to direct timing of oxytocin administration in cesarean deliveries. This study will evaluate both estimated and quantitative blood loss for both groups of patients. It will also compare the change from pre-operative to post-operative hemoglobin levels.
Interventions
DRUGOxytocin
Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta
DRUGPlacebo
Placebo will be administered after delivery of the placenta
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double blind: Obstetricians, Anesthesiologists and patients will be blinded. Only nurses will be aware of timing of oxytocin administration
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women undergoing cesarean section at Loyola Hospital * Women who read and speak the English and/or Spanish language * Women age 18 or older
Exclusion criteria
* Women who deliver vaginally * Gestation under 37 weeks and 0 days * Women with coagulopathies * Multiple gestation pregnancies * Antepartum hemorrhage for example abruption * Placental abnormalities for example previa, accreta
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total blood loss | At the completion of the surgery when patient is transferred to recovery from the operating room | Both the estimated blood loss and quantitative blood loss will be determined |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postpartum hemorrhage | At the completion of the surgery when patient is transferred to recovery from the operating room | The number of women who lose 1,000 milliliters or more blood from cesarean delivery |
| Need for transfusion | In the immediate 24 hours post surgery | The number of women who require a blood transfusion due to surgical blood loss |
| Change in pre-operative to post-operative hemoglobin levels | Baseline and Post operative day number 1 | Hemoglobin levels |
Countries
United States
Outcome results
None listed