What side effects are associated with this type of intervention?

Common treatments for postpartum hemorrhage (PPH) include uterotonics like oxytocin, misoprostol, and ergometrine, as well as calcium gluconate and calcium chloride for managing hypocalcemia. Oxytocin can cause side effects such as nausea, vomiting, and a decrease in blood pressure. Misoprostol may lead to fever, chills, and diarrhea. Ergometrine can cause hypertension, nausea, and vomiting. Calcium gluconate and calcium chloride, while generally safe, can cause local irritation at the injection site, hypercalcemia, and in rare cases, cardiac arrhythmias.

What prior FDA approvals exist?

The FDA has approved several treatments for postpartum hemorrhage, including uterotonics like oxytocin, misoprostol, and methylergonovine, which help contract the uterus to reduce bleeding. Additionally, tranexamic acid, an antifibrinolytic agent, has been studied and used to reduce blood loss in PPH. While calcium gluconate and calcium chloride are not specifically FDA-approved for PPH, they are critical in managing hypocalcemia and other conditions that can arise during childbirth. These calcium formulations are being studied to determine their pharmacokinetics and dose equivalence, which could potentially support their use in managing PPH-related complications.

What other types of research exist?

Carbetocin is a promising novel alternative to calcium gluconate and calcium chloride for postpartum hemorrhage patients. It has been shown to reduce the need for additional uterotonics without significant changes in blood pressure or pulse rate.

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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

Must not have

Patient age <18 years or >45 years

Renal dysfunction with serum Cr > 1.0 mg/dL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10-60 minutes after infusion initiation

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine the appropriate doses of two types of calcium for women giving birth, especially those having a surgical delivery. Calcium is crucial for many medical conditions and may help reduce blood loss during delivery. The study will help doctors choose the right dose and manage drug shortages better.

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am either younger than 18 or older than 45.

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My kidney function is impaired with a creatinine level over 1.0 mg/dL.

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I have a history of heart disease or irregular heartbeats.

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I am currently taking digoxin.

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I am currently taking medication for my blood pressure.

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My weight is either below 55kg or above 100kg.

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I received calcium during surgery as needed.

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

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

Primary study objectives

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 study objectives

Baseline serum ionized calcium concentration

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

Serum pH

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Calcium chloride and calcium gluconate are used in the treatment of postpartum hemorrhage (PPH) primarily to enhance uterine contractility and stabilize maternal hemodynamics. Calcium plays a crucial role in muscle contraction, including the uterine muscles, by facilitating the interaction between actin and myosin, which are essential for muscle contraction. This is particularly important in PPH patients as effective uterine contractions are necessary to compress blood vessels and reduce bleeding. Additionally, calcium administration can counteract the hypotensive effects of other medications like oxytocin, which is commonly used to induce uterine contractions but can cause a drop in blood pressure. By stabilizing blood pressure and enhancing uterine tone, calcium chloride and calcium gluconate help manage and mitigate the severe blood loss associated with PPH.

The effect of co-administration of intravenous calcium chloride and oxytocin on maternal hemodynamics and uterine tone following cesarean delivery: a double-blinded, randomized, placebo-controlled trial.