University of Michigan
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
Location contact
AnneMarie E Opipari, M.D.
CONTACT
Hero Eisley, M.D.
CONTACT
Molly J Stout, M.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07217899
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 2
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
AnneMarie E Opipari, M.D.
CONTACT
Hero Eisley, M.D.
CONTACT
Molly J Stout, M.D.
PRINCIPAL_INVESTIGATOR
This study is FDA IND exempt
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
slow push intravenous administration of 75 mL of IV
Time frame: Immediately following surgery
Standardized volumetric assessment of blood loss during cesarean section
Time frame: 4 hours following surgery
Standardized volumetric/gravimetric assessment of blood loss during cesarean section
Time frame: 4 hours following surgery
Quantitative blood loss ≥1000mL
Time frame: Calculated at 48 hours from delivery
Any transfusion prior to discharge
Time frame: Preoperative day one, Postoperative day one
Preoperative HCT and Post operative HCT measured though blood sample
Time frame: Preoperative day one, Postoperative day one
Preoperative HGB - Post operative HGB measured though blood sample
Time frame: Calculated at four hours from surgical end
specific items of interest: Methylergonovine, Carboprost, or Misoprostol
Time frame: Within 48 hours of cesarean section
Assessed using medical records
Time frame: Within 48 hours of cesarean section
Defined as requiring: Balloon Tamponade, Other atony device, B-Lynch, Uterine artery Ligation (Suture), Uterine Artery Embolization, Hysterectomy
Contact information is provided by the study sponsor or research team.
AnneMarie Opipari, MD
CONTACT
Hero Eisley
CONTACT
University of Michigan
Other
Phase II, Randomized, Double Blinded, Placebo Controlled Superiority Trial of Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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