Clinical trial NCT06650930: Pharmacokinetics of Oral Calcium Carbonate in Parturients
Official title: Pharmacokinetics of Oral Calcium Carbonate in Parturients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Pregnancy
Pharmacokinetics
Postpartum Hemorrhage
Keywords: calcium
oral calcium
calcium carbonate
calcium pharmacokinetics
pharmacokinetics in pregnancy
postpartum hemorrhage
ionized calcium
pharmacokinetics
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ionized calcium concentration
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Children's Health, Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Jessica Ansari, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.