Phase
Condition
Uterine Disorders
Treatment
Saline
Calcium Gluconate
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
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 tocesarean delivery
Or Scheduled Cesarean Delivery at High Risk for Atonic Bleeding Defined as scheduledCesarean-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
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 forseizure 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 obstetricianor 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
Study Design
Study Description
Connect with a study center
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
United StatesActive - Recruiting

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