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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 2, 7, and 12 minutes after fetal delivery. the absolute 12 minute score as well as delta from 12-2 and 12-7 minute scores will be analyzed
Awards & highlights
CALBLOC Trial 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
CALBLOC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of operating room time
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of operating room time
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
Percent change in heart rate from baseline
+8 moreCALBLOC 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?
Stanford UniversityLead Sponsor
2,408 Previous Clinical Trials
17,343,087 Total Patients Enrolled
4 Trials studying Postpartum Hemorrhage
15,125 Patients Enrolled for Postpartum Hemorrhage
Jessica Ansari, MDPrincipal InvestigatorStanford University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken medication for high blood pressure called calcium channel blocker within the last 24 hours.You have a pre-existing heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Saline placebo
- Group 2: Calcium chloride
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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