Postpartum Hemorrhage
Conditions
Keywords
Oxytocin, blood loss, Cesarean delivery
Brief summary
Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to maintain adequate uterine tone after delivery. The study investigators aim to compare two different infusion rates of oxytocin to assess the optimal infusion regimen for reducing blood loss in women undergoing elective Cesarean delivery.
Detailed description
Oxytocin (pitocin) is a drug commonly used in obstetric practice, and the drug effect is to increase the muscular tone of the uterus to reduce uterine bleeding after neonatal delivery. Pregnant patients undergoing elective (scheduled)Cesarean delivery routinely receive oxytocin after delivery of the baby. Post-delivery, oxytocin is commonly administered as an IV bolus and/or infusion. No previous studies have accurately assessed differences in oxytocin infusions after delivery in patients undergoing elective cesarean delivery. Thus the study aim is to investigate which infusion rate can optimally provide adequate maintenance of uterine tone during Cesarean delivery while being associated with minimal or no maternal side-effects.
Interventions
Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy pregnant patients with uncomplicated pregnancies: * ASA (American Association of Anesthesiologists) class 1 or 2 patients. * Singleton pregnancies.
Exclusion criteria
* ASA class 3 or 4 patients. * Known drug allergy to intravenous oxytocin. * Significant medical or obstetric disease. * Known uterine abnormality. * Known placental abnormality.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Estimated Blood Loss | immediately at end of surgery | Blood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Indices After Cesarean Delivery | 24 hr after cesarean delivery | Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin Infusion 1 Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit. | 27 |
| Oxytocin Infusion 2 Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit. | 24 |
| Total | 51 |
Baseline characteristics
| Characteristic | Oxytocin Infusion 1 | Oxytocin Infusion 2 | Total |
|---|---|---|---|
| Age, Continuous | 34 years STANDARD_DEVIATION 6 | 32 years STANDARD_DEVIATION 5 | 33 years STANDARD_DEVIATION 6 |
| Gender Female | 27 Participants | 24 Participants | 51 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 27 participants | 24 participants | 51 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 24 |
| serious Total, serious adverse events | 0 / 27 | 0 / 24 |
Outcome results
Primary
Total Estimated Blood Loss
Blood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps).
Time frame: immediately at end of surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxytocin Infusion 1 | Total Estimated Blood Loss | 512 ml |
| Oxytocin Infusion 2 | Total Estimated Blood Loss | 634 ml |
Secondary
Hemoglobin Indices After Cesarean Delivery
Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery
Time frame: 24 hr after cesarean delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxytocin Infusion 1 | Hemoglobin Indices After Cesarean Delivery | 11. g/dl |
| Oxytocin Infusion 2 | Hemoglobin Indices After Cesarean Delivery | 11.2 g/dl |