Blood Loss, SurgicalPhase 2NCT07217899
Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
A Phase 2 study testing Calcium Gluconate and Saline in people with Blood Loss, Surgical and Blood Loss, Postoperative, run by University of Michigan at 1 site in United States.
Trial summary
This research study is being done to learn what effect a single dose of calcium gluconate will have on blood loss at the time of cesarean delivery in pregnancy patients at high risk for uterine atony. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Blood Loss, Surgical, Blood Loss, Postoperative, Uterine Atony
- What is being tested?
- Calcium Gluconate and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Viable Intrauterine Pregnancy, Gestational Age ≥24 weeks
- Labor Converted to Cesarean Delivery at High Risk for Atonic Bleeding Defined as: Any exposure to oxytocin infusion for labor augmentation or induction prior to cesarean delivery
- Or Scheduled Cesarean Delivery at High Risk for Atonic Bleeding Defined as scheduled Cesarean-Section (CS) plus any one of:
- > 4 Prior deliveries
- General anesthesia
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- Multifetal gestation
- Polyhydramnios diagnosed by ultrasound within 2 weeks
- Macrosomia ≥ 4000gms; estimated fetal weight by palpation or by ultrasound
- Fibroid uterus, defined as: Multiple ≥ 2cm intramural
- Any history of prior Primary postpartum hemorrhage (PPH)
- Platelets < 100,000 (but >50,000
- Placenta Previa
- Body Mass Index (BMI) ≥ 40
Who cannot join
- Non-English speaking
- Antenatal suspicion for placenta accreta spectrum
- History of allergic reaction to Calcium Gluconate
- Patients with hypertensive disorder of pregnancy receiving Magnesium Sulfate for seizure prophylaxis
- Underlying Renal Disease defined as Cr>1.0
- Known underlying cardiac condition
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- Cardiac glycosides (Digoxin) within two weeks for maternal or fetal indication
- Treatment with a calcium channel blocker medication within 24 hours of screening
- Hypertensive disorder necessitating intravenous antihypertensive medication within 24 hours of screening
- Emergent case where study participation could impede care (judgement of obstetrician or anesthesiologist)
- Known hypercalcemia
- Concurrent use of any drugs that may cause hypercalcemia including
- Vitamin D
- Vitamin A
- Thiazide Diuretics
- Calcipotriene
- Teriparatide
- Ceftriaxone within 48 hours of screening
- Total Parenteral Nutrition (TPN) within 48 hours of screening
- Known Coagulopathy International Normalized Ratio (INR) ≥ 1.5
- Vaginal delivery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
AnneMarie E Opipari, M.D., 734-763-8048, opipari@med.umich.edu
Hero Eisley, M.D., parkerdh@med.umich.edu
About this study
Official title: Phase II, Randomized, Double Blinded, Placebo Controlled Superiority Trial of Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
This research study is being done to learn what effect a single dose of calcium gluconate will have on blood loss at the time of cesarean delivery in pregnancy patients at high risk for uterine atony.
Read the detailed description
This study is FDA IND exempt
- Being tested
- Calcium Gluconate, Saline
- Keywords
- Cesarean delivery
- Medical subject headings
- Blood Loss, Surgical, Postoperative Hemorrhage, Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium GluconateDrug
slow push intravenous administration of 2g calcium gluconate- 20 mL of 10% Calcium Gluconate in 55mL of IV fluid diluent, Normal Saline CaGluc concentration 26.7 mg/mL
SalineOther
slow push intravenous administration of 75 mL of IV
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Randomized to receive intervention Receives: Drug: Calcium Gluconate |
| Arm 2 | Placebo comparator | Randomized to receive placebo Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery
Standardized volumetric assessment of blood loss during cesarean section
Measured: Immediately following surgery
Secondary outcomes (8)
Quantitative Blood Loss (QBL) (continuous variable) Total
Standardized volumetric/gravimetric assessment of blood loss during cesarean section
Measured: 4 hours following surgery
Postpartum hemorrhage
Quantitative blood loss ≥1000mL
Measured: 4 hours following surgery
Number of patients with a transfusion requirement
Any transfusion prior to discharge
Measured: Calculated at 48 hours from delivery
Change in Hematocrit (HCT)
Preoperative HCT and Post operative HCT measured though blood sample
Measured: Preoperative day one, Postoperative day one
Change in Hemoglobin (HGB)
Preoperative HGB - Post operative HGB measured though blood sample
Measured: Preoperative day one, Postoperative day one
Number of participants with second line uterotonic requirements
specific items of interest: Methylergonovine, Carboprost, or Misoprostol
Measured: Calculated at four hours from surgical end
Intensive Care Unit Admission
Assessed using medical records
Measured: Within 48 hours of cesarean section
Additional hemostasis procedures
Defined as requiring: Balloon Tamponade, Other atony device, B-Lynch, Uterine artery Ligation (Suture), Uterine Artery Embolization, Hysterectomy
Measured: Within 48 hours of cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start20 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Molly Stout, University of Michigan
- Investigators
- AnneMarie Opipari, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217899
- Sponsor's protocol ID
- HUM00259931
- Status last verified
- Jul 2026
- First submitted
- 14 Oct 2025
- Last updated
- 24 Jul 2026
- Results posted
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Double Blinded, Placebo Controlled Superiority Trial of Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
- ClinicalTrials.gov ID
- NCT07217899
- Acronym / sponsor ID
- HUM00259931
- Keywords
- Cesarean delivery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Oct 2025 (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.
This research study is being done to learn what effect a single dose of calcium gluconate will have on blood loss at the time of cesarean delivery in pregnancy patients at high risk for uterine atony.
Detailed description
This study is FDA IND exempt
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Calcium GluconateRandomized to receive intervention |
| Arm 2 | Placebo comparator | Other: SalineRandomized to receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- English speaking
- Viable Intrauterine Pregnancy, Gestational Age ≥24 weeks
- Labor Converted to Cesarean Delivery at High Risk for Atonic Bleeding Defined as: Any exposure to oxytocin infusion for labor augmentation or induction prior to cesarean delivery
- Or Scheduled Cesarean Delivery at High Risk for Atonic Bleeding Defined as scheduled Cesarean-Section (CS) plus any one of:
Key exclusion criteria (21 listed)
- Non-English speaking
- Antenatal suspicion for placenta accreta spectrum
- History of allergic reaction to Calcium Gluconate
- Patients with hypertensive disorder of pregnancy receiving Magnesium Sulfate for seizure prophylaxis
- Underlying Renal Disease defined as Cr>1.0
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 Gluconateslow push intravenous administration of 2g calcium gluconate- 20 mL of 10% Calcium Gluconate in 55mL of IV fluid diluent, Normal Saline CaGluc concentration 26.7 mg/mL | Drug | Arm 1 |
| Salineslow push intravenous administration of 75 mL of IV | Other | Arm 2 |
Primary outcome
Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery
Time frame: Immediately following surgery
Standardized volumetric assessment of blood loss during cesarean section
8 secondary outcomes
Quantitative Blood Loss (QBL) (continuous variable) Total
Time frame: 4 hours following surgery
Postpartum hemorrhage
Time frame: 4 hours following surgery
Number of patients with a transfusion requirement
Time frame: Calculated at 48 hours from delivery
Change in Hematocrit (HCT)
Time frame: Preoperative day one, Postoperative day one
Change in Hemoglobin (HGB)
Time frame: Preoperative day one, Postoperative day one
Number of participants with second line uterotonic requirements
Time frame: Calculated at four hours from surgical end
Intensive Care Unit Admission
Time frame: Within 48 hours of cesarean section
Additional hemostasis procedures
Time frame: Within 48 hours of cesarean section
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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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.
AnneMarie Opipari, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcium Gluconate and Saline in people with Blood Loss, Surgical and Blood Loss, Postoperative, run by University of Michigan 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 14 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AnneMarie Opipari, MD (734-763-8048, opipari@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery (time frame: Immediately following surgery). 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 24 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.