Phase II, Randomized, Double Blinded, Placebo Controlled Superiority Trial of Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
University of Michigan
Summary
This research study is being done to learn what effect a single dose of calcium gluconate will have on blood loss at the time of cesarean delivery in pregnancy patients at high risk for uterine atony.
Description
This study is FDA IND exempt
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * English speaking * Viable Intrauterine Pregnancy, Gestational Age ≥24 weeks * Labor Converted to Cesarean Delivery at High Risk for Atonic Bleeding Defined as: Any exposure to oxytocin infusion for labor augmentation or induction prior to cesarean delivery * Or Scheduled Cesarean Delivery at High Risk for Atonic Bleeding Defined as scheduled Cesarean-Section (CS) plus any one of: 1. \> 4 Prior deliveries 2. General anesthesia 3. Multifetal gestation 4. Polyhydramnios diagnosed by ultrasound within 2 weeks 5. Macrosomia ≥ 4000gms; estimated fetal weight by palp…
Interventions
- DrugCalcium Gluconate
slow push intravenous administration of 2g calcium gluconate- 20 mL of 10% Calcium Gluconate in 55mL of IV fluid diluent, Normal Saline CaGluc concentration 26.7 mg/mL
- OtherSaline
slow push intravenous administration of 75 mL of IV
Location
- University of MichiganAnn Arbor, Michigan