Pharmacokinetics of Oral Calcium Carbonate in Parturients

Early Phase 1

Not yet recruiting

• Conditions: Pregnancy; Pharmacokinetics; Postpartum Hemorrhage
• Interventions: Drug: Oral calcium carbonate

• Registration Number: NCT06650930
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-18
• Study First Posted: 2024-10-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-16
• Last Update Posted: 2024-11-20
• Study Start: 2025-01
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

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 a documented 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. Prior or planned administration of calcium by the obstetric or anesthesiology teams for clinical indications within 24 hours of study enrollment
10. Patient took a calcium supplement in the past 48 hours
11. Patient status is NPO (nothing by mouth) as ordered by the clinical team

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral calcium carbonate	Oral calcium carbonate	Patients take a single dose of oral calcium carbonate 3000mg

Primary Outcome Measures

Name	Time	Method
Ionized calcium concentration	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.

Trial Locations

Locations (1)

Stanford Children's Health, Lucile Packard Children's Hospital; 🇺🇸 Stanford, California, United States