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Electrolyte

Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery (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

Pivotal Trial

Summary

This trial is testing if giving calcium through a drip can help prevent severe bleeding after childbirth in women having a surgical delivery. The study focuses on women at high risk of their womb not contracting properly. By increasing calcium levels, the treatment aims to help the womb contract and reduce blood loss.

Eligible Conditions

Postpartum Hemorrhage
Postpartum hemorrhage
Uterine Atony With Hemorrhage
Cesarean Section Complications

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 minutes after fetal delivery, 5 minutes after initiating study drug infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 minutes after fetal delivery, 5 minutes after initiating study drug infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 minutes after fetal delivery, 5 minutes after initiating study drug infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quantitative Blood Loss

Secondary study objectives

Change in Hematocrit From Baseline

Fluid Requirement

Number of Participants With Postpartum Hemorrhage

+11 more

Other study objectives

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

Intravenous line pain

Change in heart rate

100%

80%

60%

40%

20%

Study treatment Arm

Calcium Chloride

Saline Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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