Pharmacokinetics of Oral Calcium Carbonate in Parturients

NCT06650930 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 77182
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the time course of change in calcium in the blood after a pregnant subject takes an oral dose of calcium carbonate (commonly marketed as "Tums"). This information is important for trials investigating whether calcium can reduce postpartum hemorrhage, bleeding after delivery.

Conditions

Pregnancy; Pharmacokinetics; Postpartum Hemorrhage

Keywords

calcium; oral calcium; calcium carbonate; calcium pharmacokinetics; pharmacokinetics in pregnancy; postpartum hemorrhage; ionized calcium; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Ionized calcium concentration

  Ionized calcium (mmol/L) is measured at baseline and over 5 additional convenience timepoints over the 4 hours after ingestion of calcium carbonate 3000mg.

  4 hours

Study Arms (1)

Oral calcium carbonate

EXPERIMENTAL

Patients take a single dose of oral calcium carbonate 3000mg

Drug: Oral calcium carbonate

Interventions

Oral calcium carbonate DRUG

All participants receive a single, open-label dose of oral calcium carbonate 3000mg

Oral calcium carbonate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant female subjects at the study institution, admitted for labor (spontaneous, augmented, or induced)

You may not qualify if:

• severe range blood pressure (BP \>160/\>110) within the 48 hours prior to delivery
• patient age \<18 years or \>45 years
• renal dysfunction with a documented serum Cr \> 1.0 mg/dL
• known history of congenital or acquired cardiac disease or history of arrhythmia
• patient taking digoxin
• patient currently taking a calcium channel blocker
• Weight \<55kg or \>100kg, or
• receiving magnesium infusion within 24 hours prior to or during cesarean delivery
• Prior or planned administration of calcium by the obstetric or anesthesiology teams for clinical indications within 24 hours of study enrollment
• Patient took a calcium supplement in the past 48 hours
• Patient status is NPO (nothing by mouth) as ordered by the clinical team

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Children's Health, Lucile Packard Children's Hospital

Stanford, California, 94305, United States

Location

Related Publications (4)

• Ansari JR, Yarmosh A, Michel G, Lyell D, Hedlin H, Cornfield DN, Carvalho B, Bateman BT. Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2024 Jan 1;143(1):104-112. doi: 10.1097/AOG.0000000000005441. Epub 2023 Nov 3.

  PMID: 37917943 BACKGROUND

• Ansari JR, Kalariya N, Carvalho B, Flood P, Guo N, Riley E. Calcium chloride for the prevention of uterine atony during cesarean delivery: A pilot randomized controlled trial and pharmacokinetic study. J Clin Anesth. 2022 Sep;80:110796. doi: 10.1016/j.jclinane.2022.110796. Epub 2022 Apr 18.

  PMID: 35447502 BACKGROUND

• Ansari JR, Conti DJ, Michel G, Yarmosh A, Cole NM, Shafer SL. Bioequivalence and Pharmacokinetics of Intravenous Calcium during Cesarean Delivery. Anesthesiology. 2025 Jan 1;142(1):121-131. doi: 10.1097/ALN.0000000000005248.

  PMID: 39361822 BACKGROUND

• Ansari J, Carvalho B, Shafer SL, Flood P. Pharmacokinetics and Pharmacodynamics of Drugs Commonly Used in Pregnancy and Parturition. Anesth Analg. 2016 Mar;122(3):786-804. doi: 10.1213/ANE.0000000000001143.

  PMID: 26891392 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Jessica Ansari, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica R Ansari, MD, MS

CONTACT

650-723-4000; jansari@stanford.edu

Jordan Abrams, MD

CONTACT

650-723-4000; abramsj@stanford.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single arm pharmacokinetic trial. No efficacy outcomes are analyzed. The aim of the study is to determine the pharmacokinetics of a single dose of oral calcium carbonate in parturients. The outcome of interest is serial measurement of the ionized calcium in the blood.

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: January 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)