Pharmacokinetics of Oral Calcium Carbonate in Parturients

Stanford University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Postpartum Hemorrhage; Pharmacokinetics; Pregnancy

Treatments: Drug: Oral calcium carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT06650930

77182

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Oral calcium carbonate

Experimental group

Description:

Patients take a single dose of oral calcium carbonate 3000mg

Treatment:

Drug: Oral calcium carbonate