Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery
Status:
Not yet recruiting
Trial end date:
2027-06-01
Target enrollment:
Participant gender:
Summary
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.