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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07217899
Phase
PHASE2
Status
Recruiting
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Conditions

  • Blood Loss, Postoperative
  • Blood Loss, Surgical
  • Uterine Atony

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • Saline — OTHER
    slow push intravenous administration of 75 mL of IV

Study Details

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.

Key Dates

Start date
Oct 20, 2025
Status verified
Oct 2025
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm 1
    Randomized to receive intervention
  • Placebo Comparator: Arm 2
    Randomized to receive placebo

Primary Outcome Measure

Quantitative Blood Loss (QBL) (continuous variable) administered at Delivery [ Time Frame: Immediately following surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
AnneMarie E Opipari, M.D.
[email protected]
734-763-8048
Hero Eisley, M.D.
[email protected]
Molly J Stout, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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