What this study is
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.
What's being tested
- Calcium Gluconate
Intervention · DRUG
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
Intervention · OTHER
slow push intravenous administration of 75 mL of IV
Study details
- Official title
- 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
- Conditions
- Blood Loss, Surgical · Blood Loss, Postoperative · Uterine Atony
- Enrolling
- 140 people
- Starts
- 2025-10-20
- Est. completion
- 2026-08
- Design
- Triple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Michigan
Ann Arbor, Michigan, United States
- AnneMarie E Opipari, M.D. · Contact734-763-8048opipari@med.umich.edu
- Hero Eisley, M.D. · Contactparkerdh@med.umich.edu
- Molly J Stout, M.D. · Principal investigator
Recruiting
Study team
Sponsor
University of Michigan
Study ID HUM00259931
Principal investigator
AnneMarie Opipari, MD
University of Michigan
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.