One IV dose of calcium gluconate given before cesarean to reduce bleeding in people at high risk for uterine atony

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, single-center interventional study at the University of Michigan gives eligible participants a single intravenous dose of calcium gluconate or saline as a comparator at the time of cesarean delivery. Eligible patients are ≥24 weeks with a viable pregnancy and considered high risk for uterine atony either because of prior oxytocin exposure during labor or because a scheduled cesarean meets predefined risk factors (for example multiple prior deliveries, multifetal gestation, placenta previa, high BMI, large fibroids, or prior postpartum hemorrhage). The trial measures measured blood loss at the time of surgery and standard postpartum hemorrhage outcomes such as need for additional uterotonics, transfusion, or surgical interventions. The protocol is FDA IND-exempt and aims to see whether prophylactic IV calcium can reduce atonic bleeding compared with saline.

Why it matters

Who can join: the full rules

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:

  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 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

  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

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: AnneMarie Opipari, MD — University of Michigan
• Study coordinator: AnneMarie Opipari, MD
• Email: opipari@med.umich.edu
• Phone: 734-763-8048

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.