Calcium Chloride for Prevention of Uterine Atony During Cesarean

Trial ID or NCT#

NCT03867383

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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:
    1. * 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:
  1. * 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
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Investigator(s)

Brendan Carvalho
Brendan Carvalho
Anesthesiologist
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

Contact us to find out if this trial is right for you.

Contact

Brendan Carvalho, MBBCh, FRCA
650-861-8607

View on ClinicalTrials.gov