Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony

Last updated: October 28, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

2

Condition

Uterine Disorders

Treatment

Saline

Calcium Gluconate

Clinical Study ID

NCT07217899
HUM00259931
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 tocesarean delivery

  • Or Scheduled Cesarean Delivery at High Risk for Atonic Bleeding Defined as scheduledCesarean-Section (CS) plus any one of:

  1. > 4 Prior deliveries

  2. General anesthesia

  3. Multifetal gestation

  4. Polyhydramnios diagnosed by ultrasound within 2 weeks

  5. Macrosomia ≥ 4000gms; estimated fetal weight by palpation or by ultrasound

  6. Fibroid uterus, defined as: Multiple ≥ 2cm intramural

  7. Any history of prior Primary postpartum hemorrhage (PPH)

  8. Platelets < 100,000 (but >50,000

  9. Placenta Previa

  10. Body Mass Index (BMI) ≥ 40

Exclusion

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 forseizure 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 obstetricianor anesthesiologist)

  • Known hypercalcemia

  • Concurrent use of any drugs that may cause hypercalcemia including

  1. Vitamin D

  2. Vitamin A

  3. Thiazide Diuretics

  4. Calcipotriene

  5. 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

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Saline
Phase: 2
Study Start date:
October 20, 2025
Estimated Completion Date:
August 31, 2026

Study Description

This study is FDA IND exempt

Connect with a study center

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.