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NCT03867383 · ClinicalTrials.gov registry record · Phase 1
Calcium Chloride for Prevention of Uterine Atony During Cesarean
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT03867383: Completed Phase 1 study, sponsored by Stanford University.
NCT03867383 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03867383, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome of interest is the presence of clinical uterine atony, as defined the by any of the following: 1. Administration of \> 1 bolus of oxytocin 2. Increase in the oxytocin infusion rate above the standard 7.5units/hour 3. Administration of a second line uterotonic including methylergonovine, carboprost, or misoprostol 4. Mechanical surgical interventions for uterine atony including placement of an intrauterine balloon, B-lynch sutures, or O'Leary sutures 5. Requirement for emboli
Interventions
- DRUG Placebo
- DRUG Calcium Chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-03-15 |
| Est. Completion | 2021-08-15 |
| Phase | Phase 1 |
What the finished NCT03867383 record still lists
NCT03867383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03867383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03867383 about?
NCT03867383 is a clinical study titled "Calcium Chloride for Prevention of Uterine Atony During Cesarean". 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 aft...
What is the current status of trial NCT03867383?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2019-03-15. Estimated completion is 2021-08-15.
What interventions are being tested in trial NCT03867383?
The interventions under investigation include: Placebo (DRUG), Calcium Chloride (DRUG).
Who is sponsoring clinical trial NCT03867383?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03867383's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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