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