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Recruiting NCT07217899

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

Conditions: Blood Loss, Surgical, Blood Loss, Postoperative, Uterine Atony

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 140
Sponsor: University of Michigan

Location: University of Michigan Ann Arbor Michigan

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07217899). StuddyBuddy aggregates publicly available trial information.