Calcium Chloride for Prevention of Uterine Atony During Cesarean (NCT03867383) | Clinical Trial Compass
CompletedPhase 1/2
Calcium Chloride for Prevention of Uterine Atony During Cesarean
United States40 participantsStarted 2019-03-15
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Uterine Atony
Timeframe: From time of fetal delivery until 4 hours after fetal delivery