Actively Recruiting
Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
Led by University of Michigan · Updated on 2025-10-29
140
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English speaking
- Viable intrauterine pregnancy with gestational age of 24 weeks or more
- Labor converted to cesarean delivery with any exposure to oxytocin infusion for labor augmentation or induction prior to cesarean delivery
- Scheduled cesarean delivery at high risk for atonic bleeding defined by having any one of the following: more than 4 prior deliveries, general anesthesia, multifetal gestation, polyhydramnios diagnosed by ultrasound within 2 weeks, macrosomia of 4000 grams or more estimated by palpation or ultrasound, fibroid uterus with multiple intramural fibroids 2 cm or larger, history of prior primary postpartum hemorrhage, platelet count less than 100,000 but more than 50,000, placenta previa, or body mass index of 40 or higher
You will not qualify if you...
- Non-English speaking
- Antenatal suspicion for placenta accreta spectrum
- History of allergic reaction to calcium gluconate
- Hypertensive disorder of pregnancy receiving magnesium sulfate for seizure prophylaxis
- Underlying renal disease with creatinine greater than 1.0
- Known underlying cardiac condition
- Use of cardiac glycosides (Digoxin) within two weeks for maternal or fetal indication
- Treatment with calcium channel blocker medication within 24 hours of screening
- Hypertensive disorder requiring intravenous antihypertensive medication within 24 hours of screening
- Emergent case where study participation could impede care based on obstetrician or anesthesiologist judgment
- Known hypercalcemia
- Concurrent use of drugs that may cause hypercalcemia including vitamin D, vitamin A, thiazide diuretics, calcipotriene, teriparatide
- Use of ceftriaxone within 48 hours of screening
- Total parenteral nutrition within 48 hours of screening
- Known coagulopathy with international normalized ratio of 1.5 or higher
- Vaginal delivery
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
A
AnneMarie Opipari, MD
CONTACT
H
Hero Eisley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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