Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT07217899

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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