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NCT Number: NCT06650930

Pharmacokinetics of Oral Calcium Carbonate in Parturients

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Oral calcium carbonate

Drug

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

Primary outcomes

  1. Ionized calcium concentration

    Time frame: 4 hours

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica R Ansari, MD, MS

CONTACT

[email protected]

650-723-4000

Jordan Abrams, MD

CONTACT

[email protected]

650-723-4000

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 21, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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