Status:
COMPLETED
Calcium Chloride for Prevention of Uterine Atony During Cesarean
Lead Sponsor:
Stanford University
Conditions:
Uterine Atony
Uterine Atony With Hemorrhage
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
PHASE2
Brief 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 m...
Detailed Description
Poor contraction of the uterus, also known as uterine atony, is the leading cause of severe blood loss during Cesarean section, both in the US and worldwide. Exogenous calcium has been shown to increa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03867383
Start Date
March 15 2019
End Date
August 15 2021
Last Update
April 28 2022
Active Locations (1)
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1
Lucile Packard Children's Hospital
Stanford, California, United States, 94305