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Calcium Chloride for Prevention of Uterine Atony During Cesarean
Not Recruiting
Trial ID: NCT03867383
Purpose
In this pilot study, investigators will administer calcium chloride or placebo to pregnant
women undergoing Cesarean delivery who have been identified as high risk for hemorrhage due
to poor uterine muscle contraction, or atony. They will assess whether a single dose of
calcium given immediately after the delivery of the fetus decreases the incidence of uterine
atony and bleeding for the mother. The pharmacokinetics of calcium chloride in pregnant women
will also be established. Data from this pilot study of 40 patients will be used to determine
sample size and appropriateness of a larger randomized clinical trial.
Official Title
Calcium Chloride in the Prevention of Uterine Atony During Cesarean in Women at Increased Risk of Hemorrhage: a Pilot Randomized Controlled Trial and Pharmacokinetic Study
Stanford Investigator(s)
Brendan Carvalho
Professor of Anesthesiology, Perioperative and Pain Medicine (Adult MSD) and, by courtesy, of Obstetrics and Gynecology (Maternal Fetal Medicine)
Jessica Rose Ansari
Clinical Assistant Professor, Anesthesiology, Perioperative and Pain Medicine
Eligibility
Inclusion Criteria:
Pregnant female subjects at Lucile Packard Children's hospital / Stanford hospital
undergoing Cesarean will be screened for inclusion in the study based upon presence of at
least 2 risk factors for uterine atony/ postpartum hemorrhage. The risk factors include the
following:
- intrapartum Cesarean delivery
- failed operative vaginal delivery with forceps or vacuum
- magnesium infusion
- chorioamnionitis
- multiple gestation
- polyhydramnios
- preterm delivery <37 weeks
- prior history of postpartum hemorrhage
- labor induction or augmentation with oxytocin
- advanced maternal age
- obesity with body mass index >40
Exclusion Criteria:
- a degree of case urgency to which taking time to consent for the study could
compromise patient care, determined by anesthesiologist or obstetrician
- patient age <18 years or >50 years
- renal dysfunction with serum Creatinine > 1.0
- abnormal cardiac function or history of arrhythmia
- patient taking digoxin
- patient currently taking a calcium channel blocker for a cardiovascular indication
Intervention(s):
drug: Calcium Chloride
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Brendan Carvalho, MBBCh, FRCA
650-861-8607