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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-20

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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This study is FDA IND exempt

Conditions

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Blood Loss, Surgical Blood Loss, Postoperative Uterine Atony

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

This trial will include blinding of the subjects, investigators, and all direct care providers. There will be an anesthesiologist who is not involved in the clinical care of the patient who will be notified of the participant's randomization.

Study Groups

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Arm 1

Randomized to receive intervention

Group Type EXPERIMENTAL

Calcium Gluconate

Intervention Type 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

Arm 2

Randomized to receive placebo

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

slow push intravenous administration of 75 mL of IV

Interventions

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Calcium Gluconate

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

Intervention Type DRUG

Saline

slow push intravenous administration of 75 mL of IV

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No