Not yet recruiting NCT06650930
Pharmacokinetics of Oral Calcium Carbonate in Parturients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral calcium carbonate.
- Who it may be relevant to
- Registry conditions: Pregnancy, Pharmacokinetics, Postpartum Hemorrhage. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Oral calcium carbonate
All participants receive a single, open-label dose of oral calcium carbonate 3000mg
Primary outcome measures
- Ionized calcium concentration [Time frame: 4 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Stanford Children's Health, Lucile Packard Children's Hospital — Stanford
Publications
- 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. PMID 37917943
- 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. PMID 35447502
- 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. PMID 39361822
- 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. PMID 26891392
Identifiers
NCT: NCT06650930 · 77182