Calcium Chloride for Prevention of Uterine Atony During Cesarean
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Uterine Atony, Uterine Atony With Hemorrhage, Cesarean Section Complications
In brief
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.
Key facts
- Study ID
- NCT03867383
- Run by
- Stanford University
- People needed
- 40
- Starts
- 2019-03-15
- Expected to finish
- 2021-08-15
- Last updated by the study team
- 2022-04-28
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Lucile Packard Children's Hospital — Stanford, California, United States
Full record on ClinicalTrials.gov
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