Recruiting
Phase 2

Calcium Gluconate

Sponsor:

University of Michigan

Code:

NCT07217899

Conditions

Blood Loss, Surgical

Blood Loss, Postoperative

Uterine Atony

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Calcium Gluconate

Saline

Study Details

Brief 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.

Conditions

Blood Loss, Surgical

Blood Loss, Postoperative

Uterine Atony

Study ID

NCT07217899

Start date

Oct 20, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 palpation or by ultrasound
6. Fibroid uterus, defined as: Multiple ≥ 2cm intramural
7. Any history of prior Primary postpartum hemorrhage (PPH)
8. Platelets < 100,000 (but >50,000
9. Placenta Previa
10. Body Mass Index (BMI) ≥ 40

Exclusion Criteria:

  • Non-English speaking
  • Antenatal suspicion for placenta accreta spectrum
  • History of allergic reaction to Calcium Gluconate
  • Patients with hypertensive disorder of pregnancy receiving Magnesium Sulfate for seizure prophylaxis
  • Underlying Renal Disease defined as Cr>1.0
  • Known underlying cardiac condition
  • Cardiac glycosides (Digoxin) within two weeks for maternal or fetal indication
  • Treatment with a calcium channel blocker medication within 24 hours of screening
  • Hypertensive disorder necessitating intravenous antihypertensive medication within 24 hours of screening
  • Emergent case where study participation could impede care (judgement of obstetrician or anesthesiologist)
  • Known hypercalcemia
  • Concurrent use of any drugs that may cause hypercalcemia including

1. Vitamin D
2. Vitamin A
3. Thiazide Diuretics
4. Calcipotriene
5. Teriparatide
  • Ceftriaxone within 48 hours of screening
  • Total Parenteral Nutrition (TPN) within 48 hours of screening
  • Known Coagulopathy International Normalized Ratio (INR) ≥ 1.5
  • Vaginal delivery

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm 1

Randomized to receive intervention

placebo comparator: Arm 2

Randomized to receive placebo

Interventions

Calcium 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

Saline

slow push intravenous administration of 75 mL of IV

Primary outcome measure

  • Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery [ Time Frame: Immediately following surgery ]

Central Contacts and Locations

Central contacts

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

AnneMarie E Opipari, M.D.

734-763-8048opipari@med.umich.edu

Hero Eisley, M.D.

parkerdh@med.umich.edu

Principal Investigator:

Molly J Stout, M.D.

More Information

Sponsor

University of Michigan

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Cesarean delivery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-24.