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Calcium Chloride for Prevention of Uterine Atony During Cesarean

NCT03867383 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-04-28

Study results available
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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.

Conditions

  • Uterine Atony
  • Uterine Atony With Hemorrhage
  • Cesarean Section Complications

Interventions

DRUG

Calcium Chloride

All included in intervention description. 1 gram of calcium chloride in total 60 milliliters normal saline

DRUG

Placebo

60 milliliters normal saline

Sponsors & Collaborators

Principal Investigators

  • Brendan Carvalho, MBBCh FRCA · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2021-07-30
Completion
2021-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03867383 on ClinicalTrials.gov