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.
This study is FDA IND exempt
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
140
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
slow push intravenous administration of 75 mL of IV
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGQuantitative Blood Loss (QBL) (continuous variable) administered at Delivery
Standardized volumetric assessment of blood loss during cesarean section
Time frame: Immediately following surgery
Quantitative Blood Loss (QBL) (continuous variable) Total
Standardized volumetric/gravimetric assessment of blood loss during cesarean section
Time frame: 4 hours following surgery
Postpartum hemorrhage
Quantitative blood loss ≥1000mL
Time frame: 4 hours following surgery
Number of patients with a transfusion requirement
Any transfusion prior to discharge
Time frame: Calculated at 48 hours from delivery
Change in Hematocrit (HCT)
Preoperative HCT and Post operative HCT measured though blood sample
Time frame: Preoperative day one, Postoperative day one
Change in Hemoglobin (HGB)
Preoperative HGB - Post operative HGB measured though blood sample
Time frame: Preoperative day one, Postoperative day one
Number of participants with second line uterotonic requirements
specific items of interest: Methylergonovine, Carboprost, or Misoprostol
Time frame: Calculated at four hours from surgical end
Intensive Care Unit Admission
Assessed using medical records
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Within 48 hours of cesarean section
Additional hemostasis procedures
Defined as requiring: Balloon Tamponade, Other atony device, B-Lynch, Uterine artery Ligation (Suture), Uterine Artery Embolization, Hysterectomy
Time frame: Within 48 hours of cesarean section