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Calcium Supplements for Postpartum Hemorrhage

Phase < 1

Waitlist Available

Led By Jessica Ansari, MD, MS

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant female subjects delivering at the study institution via scheduled cesarean delivery at term (>=37 weeks gestation)

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10-60 minutes after infusion initiation

Awards & highlights

Study Summary

This trial will help determine the best dose of a life-saving drug (calcium) for pregnant women during c-sections, and will ensure a resilient drug supply chain in times of drug shortages.

Who is the study for?

This trial is for pregnant women scheduled for a cesarean delivery at term, between the ages of 18 and 45, with a body weight between 55kg and 100kg. They must not have kidney issues (serum Cr >1.0 mg/dL), severe high blood pressure recently, heart disease or arrhythmias, be on certain heart medications like calcium channel blockers or digoxin, nor receive magnesium infusions close to delivery.Check my eligibility

What is being tested?

The study aims to compare two FDA-approved intravenous forms of calcium: Calcium Gluconate and Calcium Chloride in new mothers (parturients). It will determine how each drug is processed in the body and establish the equivalent doses needed for effective treatment during drug shortages.See study design

What are the potential side effects?

Potential side effects from both forms of calcium may include irritation at the injection site, a sense of heat or flushing if injected too quickly, low blood pressure if given rapidly by IV push, nausea or vomiting; rarely it can cause an irregular heartbeat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am pregnant and scheduled for a C-section at the study hospital after 37 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bioequivalent ratio of calcium gluconate (g) to calcium chloride (g)

Clearance from first to second compartment (L/min)

Clearance from second compartment (L/min)

+2 more

Secondary outcome measures

Baseline serum ionized calcium concentration

Peak change in serum ionized calcium concentration (mmol/L)

Serum pH

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Calcium GluconateExperimental Treatment1 Intervention

Infused intravenously over 10 minutes upon umbilical cord clamping. First 10 assigned patients received 2 grams per protocol. Subsequent 13 patients received 1.5 grams, dose recalibrated per protocol.

Group II: Calcium ChlorideActive Control1 Intervention

0.5mg calcium chloride, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Calcium Gluconate

2023

Completed Phase 3

~460

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,386 Previous Clinical Trials

17,333,974 Total Patients Enrolled

4 Trials studying Postpartum Hemorrhage

15,211 Patients Enrolled for Postpartum Hemorrhage

Jessica Ansari, MD, MSPrincipal InvestigatorStanford University

Media Library

Calcium chloride (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05973747 — Phase < 1

Postpartum Hemorrhage Research Study Groups: Calcium Gluconate, Calcium Chloride

Postpartum Hemorrhage Clinical Trial 2023: Calcium chloride Highlights & Side Effects. Trial Name: NCT05973747 — Phase < 1

Calcium chloride (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05973747 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this medical research open to individuals below the age of 65?

"This investigation into the efficacy of a potential therapy stipulates that only individuals aged 18 to 45 can apply. However, there are 78 studies for those below legal age and 383 trials available for seniors."

Answered by AI

Who is most likely to benefit from participating in this experiment?

"Qualified applicants for this trial should have experienced postpartum haemorrhage and age between 18 to 45 years. Approximately 40 patients will be admitted in the study."

Answered by AI

Are there any remaining patient slots open for this clinical exploration?

"Per the details on clinicaltrials.gov, this trial is not accepting applicants currently. It was initially published on September 1st 2023 and most recently modified on July 25th 2023. While this research isn't enrolling subjects presently, there are numerous other studies recruiting volunteers right now with a total of 506 trials open for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients

Jessica Ansari, MD 2023. "Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05973747.