Actively Recruiting
Phase II, Randomized, Double-Blinded, Placebo Controlled Trial of Prophylactic Intravenous Calcium Gluconate to Reduce Blood Loss at Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
Led by University of Michigan · Updated on 2025-10-29
140
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of a single dose of calcium gluconate on blood loss during cesarean delivery in pregnant patients who are at high risk for uterine atony. This phase II, randomized, double-blinded, placebo-controlled trial aims to determine whether prophylactic intravenous calcium gluconate can reduce bleeding during surgery. The study is FDA IND exempt and led by the University of Michigan. Participants will be randomly assigned to receive either 2g of calcium gluconate given slowly through an intravenous push diluted in saline or a placebo consisting of intravenous saline alone. The intervention is administered at the time of cesarean delivery. The study includes two groups: one receiving the calcium gluconate and the other receiving the placebo, with masking applied to participants and researchers. During the study, participants will be closely monitored for quantitative blood loss immediately after surgery and up to four hours post-surgery. Additional assessments include postpartum hemorrhage occurrence, need for blood transfusions, changes in hematocrit and hemoglobin levels, use of second-line uterotonic drugs, intensive care unit admissions, and any additional hemostasis procedures within 48 hours of delivery. The total duration and follow-up include monitoring up to 48 hours after cesarean delivery.
CONDITIONS
Brief Title
Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English speaking
- Viable intrauterine pregnancy at 24 weeks gestation or more
- Labor converted to cesarean delivery with high risk for atonic bleeding defined by any oxytocin infusion exposure prior to cesarean
- Scheduled cesarean delivery at high risk for atonic bleeding defined by scheduled cesarean plus any one of: more than 4 prior deliveries, general anesthesia, multifetal gestation, polyhydramnios within 2 weeks by ultrasound, macrosomia (estimated fetal weight 6 4000g), fibroid uterus with multiple intramural fibroids 2cm, history of prior primary postpartum hemorrhage, platelets between 50,000 and 100,000, placenta previa, or body mass index 40
You will not qualify if you...
- Non-English speaking
- Antenatal suspicion for placenta accreta spectrum
- History of allergic reaction to calcium gluconate
- Receiving magnesium sulfate for seizure prophylaxis due to hypertensive disorder of pregnancy
- Underlying renal disease with creatinine over 1.0
- Known cardiac condition
- Use of cardiac glycosides (digoxin) within two weeks
- Treatment with calcium channel blockers within 24 hours
- Hypertensive disorder requiring intravenous antihypertensive medication within 24 hours
- Emergent cases where participation could impede care
- Known hypercalcemia
- Concurrent use of drugs causing hypercalcemia including vitamin D, vitamin A, thiazide diuretics, calcipotriene, teriparatide
- Ceftriaxone use within 48 hours
- Total parenteral nutrition within 48 hours
- Known coagulopathy with INR 6 1.5
- Vaginal delivery instead of cesarean delivery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (at time of cesarean delivery)
Participants receive a slow push intravenous administration of either calcium gluconate or placebo immediately prior to cesarean delivery as part of the trial intervention.
1 visit (in-person at delivery)
Duration - Up to 48 hours after surgery
Participants are monitored for blood loss, transfusion requirements, and other outcomes for up to 48 hours following cesarean delivery.
Approximately 2 visits (in-person within 48 hours post-surgery)
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
A
AnneMarie Opipari, MD
H
Hero Eisley
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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