NCT07217899 · University of Michigan
Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
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
OTHER
Saline
slow push intravenous administration of 75 mL of IV
Primary outcome measures
Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery
Time frame: Immediately following surgery
Standardized volumetric assessment of blood loss during cesarean section
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- \> 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 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
- 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
Where
- Ann Arbor, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2026 · Source of record for eligibility and locations