Postpartum HemorrhageEarly Phase 1NCT05973747
Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients
A Early Phase 1 study testing Calcium Gluconate and Calcium chloride in people with Postpartum Hemorrhage and Pregnancy Related, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Pregnancy Related, Hypocalcemia
- What is being tested?
- Calcium Gluconate and Calcium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2023to 15 Dec 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant female subjects delivering at the study institution via scheduled cesarean delivery at term (>=37 weeks gestation)
Who cannot join
- severe range blood pressure (BP >160/>110) within the 48 hours prior to delivery
- patient age <18 years or >45 years
- renal dysfunction with 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
Show all 9Show fewer
- Weight <55kg or >100kg, or
- receiving magnesium infusion within 24 hours prior to or during cesarean delivery
- administration of intraoperative doses of calcium by the anesthesiology team for clinical indications
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital
Stanford, California, 94305
About this study
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.
- Being tested
- Calcium Gluconate, Calcium chloride
- Medical subject headings
- Postpartum Hemorrhage, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium GluconateDrug
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 chlorideDrug
0.5 grams of calcium chloride, infused intravenously over 10 minutes upon umbilical cord clamping
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Calcium Gluconate |
| Calcium Chloride | Active comparator | 0.5mg calcium chloride, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping Receives: Drug: Calcium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalent ratio of calcium gluconate (g) to calcium chloride (g)
Calculated via NONMEM
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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: 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
Measured: 10-60 minutes after infusion initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start19 Aug 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Ansari, MD, Stanford University
- Investigators
- Jessica Ansari, MD, MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973747
- Sponsor's protocol ID
- 70603
- Status last verified
- Apr 2024
- First submitted
- 13 Jul 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients
- ClinicalTrials.gov ID
- NCT05973747
- Acronym / sponsor ID
- 70603
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 19 Aug 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Gluconate | Experimental | Drug: Calcium GluconateInfused 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 | Drug: Calcium chloride0.5mg calcium chloride, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant female subjects delivering at the study institution via scheduled cesarean delivery at term (>=37 weeks gestation)
Key exclusion criteria (9 listed)
- severe range blood pressure (BP >160/>110) within the 48 hours prior to delivery
- patient age <18 years or >45 years
- renal dysfunction with serum Cr > 1.0 mg/dL
- known history of congenital or acquired cardiac disease or history of arrhythmia
- patient taking digoxin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium GluconateInfused 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. | Drug | Calcium Gluconate |
| Calcium chloride0.5 grams of calcium chloride, infused intravenously over 10 minutes upon umbilical cord clamping | Drug | Calcium Chloride |
Primary outcome
Bioequivalent ratio of calcium gluconate (g) to calcium chloride (g)
Time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
Calculated via NONMEM
Clearance from first to second compartment (L/min)
Time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
Determined using population pharmacokinetic analysis in NONMEM
Volume of distribution of first compartment of pharmacokinetic model (L)
Time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
Determined using population pharmacokinetic analysis in NONMEM
Clearance from second compartment (L/min)
Time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
Determined using population pharmacokinetic analysis in NONMEM
Volume of distribution of second compartment of pharmacokinetic model (L)
Time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
Determined using population pharmacokinetic analysis in NONMEM
4 secondary outcomes
Serum pH
Time frame: Baseline prior to calcium infusion, 6 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion
Baseline serum ionized calcium concentration
Time frame: Baseline prior to calcium infusion
Peak change in serum ionized calcium concentration (mmol/L)
Time frame: Measured immediately at completion of the 10-minute calcium infusion.
Time to half of peak change in ionized calcium (minutes)
Time frame: 10-60 minutes after infusion initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Ansari, MD, MS principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Calcium Gluconate and Calcium chloride in people with Postpartum Hemorrhage and Pregnancy Related, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalent ratio of calcium gluconate (g) to calcium chloride (g) (time frame: Using data gathered from serial lab draws at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes after initiation of infusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.