---
title: Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients
nct_id: NCT05973747
overall_status: COMPLETED
phase: EARLY_PHASE1
sponsor: Stanford University
study_type: INTERVENTIONAL
primary_condition: Postpartum Hemorrhage
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05973747.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05973747"
ct_last_update_post_date: 2024-04-11
last_seen_at: "2026-05-12T07:30:22.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients

**NCT ID:** [NCT05973747](https://clinicaltrials.gov/study/NCT05973747)

## Key Facts

- **Status:** COMPLETED
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 34
- **Lead Sponsor:** Stanford University
- **Conditions:** Postpartum Hemorrhage, Pregnancy Related, Hypocalcemia, Parturition Complication
- **Start Date:** 2023-08-19
- **Completion Date:** 2023-12-15
- **CT.gov Last Update:** 2024-04-11

## Brief Summary

Calcium is a life saving medicine in the care of parturients. It has many important uses including treatment of hypocalcemia, treatment of magnesium toxicity, prevention of hypocalcemia during blood transfusion (of citrate containing blood products), treatment of hyperkalemia, and others. Recent clinical trials also suggest that calcium given after cord clamping may decrease blood loss in patients undergoing cesarean delivery. 2 FDA approved forms of calcium can be given intravenously: calcium chloride and calcium gluconate. Over the last decade there have been times with drug shortages of either calcium chloride or calcium gluconate. So there have been and likely will continue to be times when one formulation or the other may not be adequately available. Despite the importance of calcium and the frequency in which it is used in parturients, there are no published studies in parturients to determine dose equivalence between calcium gluconate and calcium chloride. In this study the investigators will determine the population pharmacokinetics of calcium gluconate and calcium chloride in parturients and calculate the dose equivalent ratio the two drugs. This will help clinicians select appropriate doses of calcium and provide resilience to the drug supply chain in our era of frequent drug shortages.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

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

Exclusion Criteria:

1. severe range blood pressure (BP \>160/\>110) within the 48 hours prior to delivery
2. patient age \<18 years or \>45 years
3. renal dysfunction with serum Cr \> 1.0 mg/dL
4. known history of congenital or acquired cardiac disease or history of arrhythmia
5. patient taking digoxin
6. patient currently taking a calcium channel blocker
7. Weight \<55kg or \>100kg, or
8. receiving magnesium infusion within 24 hours prior to or during cesarean delivery
9. administration of intraoperative doses of calcium by the anesthesiology team for clinical indications
```

## Arms

- **Calcium Gluconate** (EXPERIMENTAL) — 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.
- **Calcium Chloride** (ACTIVE_COMPARATOR) — 0.5mg calcium chloride, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping

## Interventions

- **Calcium Gluconate** (DRUG) — 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.
- **Calcium chloride** (DRUG) — 0.5 grams of calcium chloride, infused intravenously over 10 minutes upon umbilical cord clamping

## Primary Outcomes

- **Bioequivalent ratio of calcium gluconate (g) to calcium chloride (g)** _(time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion)_ — Calculated via NONMEM
- **Clearance from first to second compartment (L/min)** _(time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion)_ — Determined using population pharmacokinetic analysis in NONMEM
- **Volume of distribution of first compartment of pharmacokinetic model (L)** _(time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion)_ — Determined using population pharmacokinetic analysis in NONMEM
- **Clearance from second compartment (L/min)** _(time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion)_ — Determined using population pharmacokinetic analysis in NONMEM
- **Volume of distribution of second compartment of pharmacokinetic model (L)** _(time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion)_ — Determined using population pharmacokinetic analysis in NONMEM

## Secondary Outcomes

- **Serum pH** _(time frame: Baseline prior to calcium infusion, 6 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion)_
- **Baseline serum ionized calcium concentration** _(time frame: Baseline prior to calcium infusion)_
- **Peak change in serum ionized calcium concentration (mmol/L)** _(time frame: Measured immediately at completion of the 10-minute calcium infusion.)_
- **Time to half of peak change in ionized calcium (minutes)** _(time frame: 10-60 minutes after infusion initiation)_

## Locations (1)

- Lucile Packard Children's Hospital, Stanford, California, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.lucile packard children's hospital|stanford|california|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05973747*  
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