CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Calcium Chloride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03867383
NCT03867383Phase 2Completed
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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 University·interventional·Posted Mar 8, 2019·Updated Apr 28, 2022

In Brief

A Phase 2 clinical trial evaluating Calcium Chloride and Placebo for Uterine Atony and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Atony, Uterine Atony With Hemorrhage, Cesarean Section Complications
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 8, 2019
Enrollment StartMar 15, 2019
Primary CompletionJul 30, 2021
Study CompletionAug 15, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.3 years ago

Interventions

Calcium Chloridedrug

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

Placebodrug

60 milliliters normal saline