drugset / Trial / NCT03867383

Calcium Chloride for Prevention of Uterine Atony During Cesarean

NCT03867383 ↗

Phase 1/2 Completed 40 enrolled Stanford University
RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2019-03-15
Primary completion
2021-07-30
Completion
2021-08-15

Outcome

Missed primary endpoint

paper The incidence of atony was 20% in parturients who received calcium compared to 50% in the placebo group (relative risk 0.38, P = 0.07 PMID 35447502 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Calcium Chloride Unknown 1 g Intravenous

Indications