Calcium Chloride for Prevention of Uterine Atony During Cesarean

• Status: Recruiting
• Trial end date: 2023-03-30
• Target enrollment: 0
• Participant gender: Female

Summary

In this pilot study, investigators will administer calcium chloride or placebo to pregnant women undergoing Cesarean delivery who have been identified as high risk for hemorrhage due to poor uterine muscle contraction, or atony. They will assess whether a single dose of calcium given immediately after the delivery of the fetus decreases the incidence of uterine atony and bleeding for the mother. The pharmacokinetics of calcium chloride in pregnant women will also be established. Data from this pilot study of 40 patients will be used to determine sample size and appropriateness of a larger randomized clinical trial.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Calcium; Calcium, Dietary

Criteria

Inclusion Criteria:

Pregnant female subjects at Lucile Packard Children's hospital / Stanford hospital undergoing Cesarean will be screened for inclusion in the study based upon presence of at least 2 risk factors for uterine atony/ postpartum hemorrhage. The risk factors include the following:

• intrapartum Cesarean delivery

• failed operative vaginal delivery with forceps or vacuum

• magnesium infusion

• chorioamnionitis

• multiple gestation

• polyhydramnios

• preterm delivery <37 weeks

• prior history of postpartum hemorrhage

• labor induction or augmentation with oxytocin

• advanced maternal age

• obesity with body mass index >40

Exclusion Criteria:

• a degree of case urgency to which taking time to consent for the study could compromise patient care, determined by anesthesiologist or obstetrician

• patient age <18 years or >50 years

• renal dysfunction with serum Creatinine > 1.0

• abnormal cardiac function or history of arrhythmia

• patient taking digoxin

• patient currently taking a calcium channel blocker for a cardiovascular indication