A Phase 2 interventional study of Calcium Gluconate and Saline in Blood Loss, Surgical, Blood Loss, Postoperative and Uterine Atony, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by University of Michigan · Phase 2, Interventional, and Prevention
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
213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
This study's planned enrollment of 140 is above the median of 80 across 160 interventional studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Or Scheduled Cesarean Delivery at High Risk for Atonic Bleeding Defined as scheduled Cesarean-Section (CS) plus any one of:
Exclusion Criteria:
Concurrent use of any drugs that may cause hypercalcemia including
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Randomized to receive intervention
Drug: Calcium Gluconate
Randomized to receive placebo
Other: Saline
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
Quantitative 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
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
Plan to share: No
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Studies of the drug tested here: Calcium Gluconate