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Electrolyte

Calcium chloride for Postpartum Hemorrhage (CALBLOC Trial)

Phase 3
Waitlist Available
Led By Jessica Ansari, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measurement occurs at conclusion of operating room case
Awards & highlights

Summary

This trial will establish the effect of 1 gram of intravenous calcium chloride upon quantitative blood loss and uterine tone during cesarean delivery in parturients with high risk of uterine atony.

Eligible Conditions
  • Postpartum Hemorrhage
  • Uterine Atony
  • Uterine Atony With Hemorrhage
  • Cesarean Section Complications

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~calculated at conclusion of operating room case
This trial's timeline: 3 weeks for screening, Varies for treatment, and calculated at conclusion of operating room case for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quantitative Blood Loss
Secondary outcome measures
Change in Hematocrit From Baseline
Fluid Requirement
Number of Participants With Postpartum Hemorrhage
+11 more
Other outcome measures
Quantitative Blood Loss, Subgroup Quantitative Blood Loss (QBL, mL), Excluding Cases of Documented Non-atonic Bleeding

Side effects data

From 2023 Phase 3 trial • 120 Patients • NCT05027048
30%
New or subjective worsening in nausea
20%
New or increased vomiting
2%
Change in heart rate
2%
Intravenous line pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Calcium Chloride
Saline Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Calcium chlorideExperimental Treatment1 Intervention
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp. This intervention occurs IN ADDITION TO standard care with oxytocin 2 unit bolus and infusion at 7.5 units per hour which begins immediately after fetal delivery.
Group II: Saline placeboPlacebo Group1 Intervention
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp. This intervention occurs IN ADDITION TO standard care with oxytocin 2 unit bolus and infusion at 7.5 units per hour which begins immediately after fetal delivery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calcium chloride
2022
Completed Phase 3
~170

Find a Location

Who is running the clinical trial?

Foundation for Anesthesia Education and ResearchOTHER
13 Previous Clinical Trials
34,401 Total Patients Enrolled
Society for Obstetric Anesthesia and PerinatologyUNKNOWN
3 Previous Clinical Trials
152 Total Patients Enrolled
1 Trials studying Postpartum Hemorrhage
40 Patients Enrolled for Postpartum Hemorrhage
Stanford UniversityLead Sponsor
2,411 Previous Clinical Trials
17,462,819 Total Patients Enrolled
4 Trials studying Postpartum Hemorrhage
15,125 Patients Enrolled for Postpartum Hemorrhage

Media Library

Calcium chloride (Electrolyte) Clinical Trial Eligibility Overview. Trial Name: NCT05027048 — Phase 3
Postpartum Hemorrhage Research Study Groups: Saline placebo, Calcium chloride
Postpartum Hemorrhage Clinical Trial 2023: Calcium chloride Highlights & Side Effects. Trial Name: NCT05027048 — Phase 3
Calcium chloride (Electrolyte) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027048 — Phase 3
~37 spots leftby Jul 2025
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