Phase 3
N=51
Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.
Postpartum Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT01932060 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Total Estimated Blood Loss — 512; 634 ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oxytocin Infusion (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Estimated Blood Loss |
512; 634 | — |
| SECONDARY Hemoglobin Indices After Cesarean Delivery |
11.; 11.2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01932060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.