RecruitingPhase 2NCT07217899

Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony

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

Sponsor

University of Michigan

Enrollment

140 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

Blood Loss, Surgical Blood Loss, Postoperative

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria14

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:
\> 4 Prior deliveries
General anesthesia
Multifetal gestation
Polyhydramnios diagnosed by ultrasound within 2 weeks
Macrosomia ≥ 4000gms; estimated fetal weight by palpation or by ultrasound
Fibroid uterus, defined as: Multiple ≥ 2cm intramural
Any history of prior Primary postpartum hemorrhage (PPH)
Platelets \< 100,000 (but \>50,000
Placenta Previa
Body Mass Index (BMI) ≥ 40

Exclusion Criteria21

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
Vitamin D
Vitamin A
Thiazide Diuretics
Calcipotriene
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

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

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