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Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery
Not Recruiting
Trial ID: NCT05027048
Purpose
Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality
worldwide. Up to 80% of PPH is caused by uterine atony, the failure of the uterine smooth
muscle to contract and compress the uterine vasculature after delivery. Laboratory and
epidemiological studies show that low extracellular and serum calcium levels, respectively,
decrease uterine contractility. A pilot study performed by the investigators supports the
hypothesis that intravenous calcium chloride is well tolerated and may have utility in
preventing uterine atony. The proposed research will establish the relationship between
uterine tone and calcium through a clinical trial with an incorporated pharmacokinetic and
pharmacodynamic (PK/PD) study. In a randomized, placebo-controlled, double-blind trial,
investigators will establish the effect of 1 gram of intravenous calcium chloride upon
quantitative blood loss and uterine tone during cesarean delivery in parturients with high
risk of uterine atony. Investigators will concurrently collect serial venous blood samples to
measure calcium for PK/PD modeling in this pregnant study cohort. High-quality clinical
research and development of novel therapeutics to manage uterine atony are critical to reduce
the high maternal morbidity and mortality from PPH.
Official Title
Calcium Chloride for Prevention of Blood Loss From Uterine Atony During Intrapartum Cesarean Delivery (CALBLOC): a Double Blind, Randomized, Placebo Controlled Trial and Nested Population Pharmacokinetic and Pharmacodynamic Analysis
Stanford Investigator(s)
Jessica Rose Ansari
Clinical Assistant Professor, Anesthesiology, Perioperative and Pain Medicine
Eligibility
Inclusion Criteria:
- Patient had a trial of labor for vaginal delivery prior to cesarean
- Patient received an oxytocin infusion for labor augmentation or induction prior to
cesarean
Exclusion Criteria:
- renal dysfunction with serum Cr >1.0 mg/dL
- known underlying cardiac condition
- treatment with digoxin within the last 2 weeks for a maternal or fetal indication
- treatment with a calcium channel blocker medication within 24 hours
- hypertension necessitating intravenous antihypertensive medication within 24 hours
- emergent case in which study participation could in any way impede patient care by the
judgement of the obstetrician, anesthesiologist, or bedside nurse
Intervention(s):
drug: Calcium chloride
drug: Saline placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jessica Ansari, MD
760-845-0328