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Calcium is a life saving medicine in the care of parturients. It has many important uses including treatment of hypocalcemia, treatment of magnesium toxicity, prevention of hypocalcemia during blood transfusion (of citrate containing blood products), treatment of hyperkalemia, and others. Recent clinical trials also suggest that calcium given after cord clamping may decrease blood loss in patients undergoing cesarean delivery. 2 FDA approved forms of calcium can be given intravenously: calcium chloride and calcium gluconate. Over the last decade there have been times with drug shortages of either calcium chloride or calcium gluconate. So there have been and likely will continue to be times when one formulation or the other may not be adequately available. Despite the importance of calcium and the frequency in which it is used in parturients, there are no published studies in parturients to determine dose equivalence between calcium gluconate and calcium chloride. In this study the investigators will determine the population pharmacokinetics of calcium gluconate and calcium chloride in parturients and calculate the dose equivalent ratio the two drugs. This will help clinicians select appropriate doses of calcium and provide resilience to the drug supply chain in our era of frequent drug shortages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Gluconate | Experimental | Infused intravenously over 10 minutes upon umbilical cord clamping. First 10 assigned patients received 2 grams per protocol. Subsequent 13 patients received 1.5 grams, dose recalibrated per protocol. |
|
| Calcium Chloride | Active Comparator | 0.5mg calcium chloride, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Gluconate | Drug | Infused intravenously over 10 minutes upon umbilical cord clamping. First 10 assigned patients received 2 grams per protocol. Subsequent 13 patients received 1.5 grams, dose recalibrated per protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalent ratio of calcium gluconate (g) to calcium chloride (g) | Calculated via NONMEM | Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion |
| Clearance from first to second compartment (L/min) | Determined using population pharmacokinetic analysis in NONMEM | Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion |
| Volume of distribution of first compartment of pharmacokinetic model (L) | Determined using population pharmacokinetic analysis in NONMEM | Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion |
| Clearance from second compartment (L/min) | Determined using population pharmacokinetic analysis in NONMEM | Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion |
| Volume of distribution of second compartment of pharmacokinetic model (L) | Determined using population pharmacokinetic analysis in NONMEM | Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Serum pH | Serum pH will be measured in each participant from a maximum of 6 venous blood draws of 0.5mL (1/10th of a teaspoon). These blood draws will be the same blood draws used to measure serum ionized calcium concentration, no additional blood draws will be necessary. These draws will occur at the following target times: prior to calcium administration, at 6 minutes, 10 minutes, 15 minutes, minutes, minutes after beginning calcium administration. The serum pH levels will be immediately analyzed using an Abbott iStat machine. |
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Inclusion Criteria:
Pregnant female subjects delivering at the study institution via scheduled cesarean delivery at term (>=37 weeks gestation)
Exclusion Criteria:
Parturients all biologically female at birth by necessity
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Ansari, MD, MS | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D006996 | Hypocalcemia |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002125 | Calcium Gluconate |
| D002122 | Calcium Chloride |
| ID | Term |
|---|---|
| D005942 | Gluconates |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Calcium chloride | Drug | 0.5 grams of calcium chloride, infused intravenously over 10 minutes upon umbilical cord clamping |
|
| Baseline prior to calcium infusion, 6 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion |
| Baseline serum ionized calcium concentration | Ionized calcium will be measured in each participant prior to administration of the 10-minute calcium infusion. The ionized blood calcium levels will be immediately analyzed using an Abbott iStat machine. | Baseline prior to calcium infusion |
| Peak change in serum ionized calcium concentration (mmol/L) | Measured via venous blood draw and an Abbott iStat CG8+ cartridge | Measured immediately at completion of the 10-minute calcium infusion. |
| Time to half of peak change in ionized calcium (minutes) | A two-compartment model does not lend itself to a meaningful half-life approximation. However, the time to serum values measuring 1/2 of the peak change in ionized calcium can be calculated from the pharmacokinetic model | 10-60 minutes after infusion initiation |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D009930 |
| Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |