NCT07217899 Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
| NCT ID | NCT07217899 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Michigan |
| Condition | Blood Loss, Surgical |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-10-20 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2025-10-20 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
AnneMarie Opipari, MD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT07217899 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Blood Loss, Surgical. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07217899 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07217899 currently recruiting?
Yes, NCT07217899 is actively recruiting participants. Contact the research team at opipari@med.umich.edu for enrollment information.
Where is the NCT07217899 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT07217899 clinical trial?
NCT07217899 is sponsored by University of Michigan. The principal investigator is AnneMarie Opipari, MD at University of Michigan. The trial plans to enroll 140 participants.