Phase 2
N=40
Calcium Chloride for Prevention of Uterine Atony During Cesarean
Uterine Atony · Uterine Atony With Hemorrhage · Cesarean Section Complications
Bottom Line
View on ClinicalTrials.gov: NCT03867383 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Uterine Atony — 4; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Calcium Chloride (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uterine Atony |
4; 10 | — |
| SECONDARY Grading of Uterine Tone |
89; 80 | — |
| SECONDARY Estimated Blood Loss |
750; 850 | — |
| SECONDARY Change in Hematocrit |
7.7; 6.7 | — |
| SECONDARY Total Crystalloid During Cesarean |
1200; 1750 | — |
| SECONDARY Maximum Increase in Heart Rate From Baseline (Beats Per Minute) |
15.4; 14.2 | — |
| SECONDARY Maximal Decrease in Heartrate From Baseline |
19.1; 16.7 | — |
| SECONDARY Maximal Increase in Mean Arterial Blood Pressure From Baseline |
15.4; 14.2 | — |
| SECONDARY Maximal Decrease in Mean Arterial Blood Pressure From Baseline |
33.8; 32.0 | — |
| SECONDARY Baseline Ionized Calcium Concentration |
1.18 | — |
| SECONDARY Clearance of Calcium Chloride |
0.93 | — |
| SECONDARY Volume of Distribution of Calcium Chloride |
76 | — |
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.
Eligibility 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 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 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
Data sourced from ClinicalTrials.gov (NCT03867383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.