Pharmacokinetics of Oral Calcium Carbonate in Parturients
NCT ID: NCT06650930
Last Updated: 2024-11-20
Study Results
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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NOT_YET_RECRUITING
EARLY_PHASE1
60 participants
INTERVENTIONAL
2025-01-31
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Oral calcium carbonate
Patients take a single dose of oral calcium carbonate 3000mg
Oral calcium carbonate
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
45 Years
FEMALE
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Jessica Ansari, MD, MS
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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
Other Identifiers
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77182
Identifier Type: -
Identifier Source: org_study_id
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