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

NCT07217899 | Recruiting Phase 2 FDA Drug

• 1 other identifier: HUM00259931
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Loss, Surgical; Blood Loss, Postoperative; Uterine Atony

Keywords

Cesarean delivery

Outcome Measures

Primary Outcomes (1)

• Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery

  Standardized volumetric assessment of blood loss during cesarean section

  Immediately following surgery

Secondary Outcomes (8)

• Quantitative Blood Loss (QBL) (continuous variable) Total

  4 hours following surgery

• Postpartum hemorrhage

  4 hours following surgery

• Number of patients with a transfusion requirement

  Calculated at 48 hours from delivery

• Change in Hematocrit (HCT)

  Preoperative day one, Postoperative day one

• Change in Hemoglobin (HGB)

  Preoperative day one, Postoperative day one

Study Arms (2)

Arm 1

EXPERIMENTAL

Randomized to receive intervention

Drug: Calcium Gluconate

Arm 2

PLACEBO COMPARATOR

Randomized to receive placebo

Other: Saline

Interventions

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

Arm 1

Saline OTHER

slow push intravenous administration of 75 mL of IV

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Blood Loss, Surgical; Postoperative Hemorrhage; Uterine Inertia

Interventions

Calcium Gluconate; Sodium Chloride

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications; Dystocia; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• AnneMarie Opipari, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AnneMarie Opipari, MD

CONTACT

734-763-8048; opipari@med.umich.edu

Hero Eisley

CONTACT

734-763-8048; parkerdh@umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology Innovation, Associate Professor of Obstetrics and Gynecology and Section Head, Maternal Fetal Medicine

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 20, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)