Calcium Chloride for Prevention of Uterine Atony During Cesarean
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/6/2019 |
| Start Date: | March 15, 2019 |
| End Date: | March 30, 2023 |
| Contact: | Jessica R Ansari, MD |
| Email: | jansari@stanford.edu |
| Phone: | 760-845-0328 |
Calcium Chloride in the Prevention of Uterine Atony During Cesarean in Women at Increased Risk of Hemorrhage: a Pilot Randomized Controlled Trial and Pharmacokinetic Study
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.
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.
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 increase uterine muscle contraction in in vitro and in animal studies. Calcium is
also an essential factor in normal blood clotting. Anesthesiologists commonly administer
intravenous calcium chloride during Cesarean as well as other types of surgery, but formal
randomized studies to determine efficacy in improving uterine tone have not been performed.
In this pilot, randomized controlled study, the anesthesiologist will administer a one-time
dose of intravenous calcium chloride 1gram versus placebo at the time of fetal delivery to
women identified as having high risk of hemorrhage during Cesarean delivery. Primary outcome
assessed will be a composite measure of uterine atony. Data from the pilot study will be used
to perform power and sample size calculations for a larger study. Secondary outcomes assessed
will include total blood loss, subjective assessment of uterine tone by the blinded
obstetrician performing surgery, safety, side effects, and pharmacokinetic profile of calcium
chloride in pregnant women.
blood loss during Cesarean section, both in the US and worldwide. Exogenous calcium has been
shown to increase uterine muscle contraction in in vitro and in animal studies. Calcium is
also an essential factor in normal blood clotting. Anesthesiologists commonly administer
intravenous calcium chloride during Cesarean as well as other types of surgery, but formal
randomized studies to determine efficacy in improving uterine tone have not been performed.
In this pilot, randomized controlled study, the anesthesiologist will administer a one-time
dose of intravenous calcium chloride 1gram versus placebo at the time of fetal delivery to
women identified as having high risk of hemorrhage during Cesarean delivery. Primary outcome
assessed will be a composite measure of uterine atony. Data from the pilot study will be used
to perform power and sample size calculations for a larger study. Secondary outcomes assessed
will include total blood loss, subjective assessment of uterine tone by the blinded
obstetrician performing surgery, safety, side effects, and pharmacokinetic profile of calcium
chloride in pregnant women.
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
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