Pharmacokinetics of Oral Calcium Carbonate in Parturients

NCT ID: NCT06650930

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-10-31

Brief Summary

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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

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Conditions

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Pregnancy Pharmacokinetics Postpartum Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Oral calcium carbonate

Patients take a single dose of oral calcium carbonate 3000mg

Group Type EXPERIMENTAL

Oral calcium carbonate

Intervention Type DRUG

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

Interventions

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Oral calcium carbonate

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jessica Ansari, MD, MS

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Ansari, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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

Stanford, California, United States

Site Status

Countries

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United States

Central Contacts

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Jessica R Ansari, MD, MS

Role: CONTACT

650-723-4000

Jordan Abrams, MD

Role: CONTACT

650-723-4000

Facility Contacts

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Jessica Ansari, MD, MS

Role: primary

650-723-4000

Jordan Abrams, MD

Role: backup

650-723-4000

References

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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.

Reference Type BACKGROUND
PMID: 37917943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35447502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39361822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26891392 (View on PubMed)

Other Identifiers

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77182

Identifier Type: -

Identifier Source: org_study_id

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