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NCT Number: NCT07217899

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

AnneMarie E Opipari, M.D.

CONTACT

[email protected]

734-763-8048

Hero Eisley, M.D.

CONTACT

[email protected]

Molly J Stout, M.D.

PRINCIPAL_INVESTIGATOR

About this study

This study is FDA IND exempt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Calcium Gluconate

Drug

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

Saline

Other

slow push intravenous administration of 75 mL of IV

Primary outcomes

  1. Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery

    Time frame: Immediately following surgery

    Standardized volumetric assessment of blood loss during cesarean section

Secondary outcomes

  1. Quantitative Blood Loss (QBL) (continuous variable) Total

    Time frame: 4 hours following surgery

    Standardized volumetric/gravimetric assessment of blood loss during cesarean section

  2. Postpartum hemorrhage

    Time frame: 4 hours following surgery

    Quantitative blood loss ≥1000mL

  3. Number of patients with a transfusion requirement

    Time frame: Calculated at 48 hours from delivery

    Any transfusion prior to discharge

  4. Change in Hematocrit (HCT)

    Time frame: Preoperative day one, Postoperative day one

    Preoperative HCT and Post operative HCT measured though blood sample

  5. Change in Hemoglobin (HGB)

    Time frame: Preoperative day one, Postoperative day one

    Preoperative HGB - Post operative HGB measured though blood sample

  6. Number of participants with second line uterotonic requirements

    Time frame: Calculated at four hours from surgical end

    specific items of interest: Methylergonovine, Carboprost, or Misoprostol

  7. Intensive Care Unit Admission

    Time frame: Within 48 hours of cesarean section

    Assessed using medical records

  8. Additional hemostasis procedures

    Time frame: Within 48 hours of cesarean section

    Defined as requiring: Balloon Tamponade, Other atony device, B-Lynch, Uterine artery Ligation (Suture), Uterine Artery Embolization, Hysterectomy

Study contacts

Contact information is provided by the study sponsor or research team.

AnneMarie Opipari, MD

CONTACT

[email protected]

734-763-8048

Hero Eisley

CONTACT

[email protected]

734-763-8048

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 20, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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