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NCT03106753 · ClinicalTrials.gov registry record · Phase 4
Success of External Cephalic Version Study
A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
NCT03106753: Clinical Trial Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03106753 is a Phase 4 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 34 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03106753, a Phase 4 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the best way to optimize the success of external cephalic version (turning the baby from the outside). Attempting to turn babies in-utero is recommended because it may decrease the risk of needing a cesarean section for abnormal presentation. While the study team knows that this procedure can be effective, the study team still has some un-answered questions as to the best way to perform this procedure to increase the chance of success. Many prior studies have shown that using spinal anesthesia (a shot of medication placed in your back to numb and relax the abdomen) can increase the success rate of a version. This ultimately has led to the finding that using this anesthesia can decrease the rate of cesarean section. However, there have been only a small number of studies assessing the success rate if spinal anesthesia is used only in the event that without it fails. Therefore the study team is going to compare patients who receive spinal anesthesia with those who only receive spinal anesthesia if the procedure to turn the baby (ECV) fails without it.
Primary Outcome
Success rate will be measured by comparing the percentage of successful external cephalic versions in each group.
Interventions
- DRUG Bupivacaine
- DRUG Terbutaline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2017-04-12 |
| Est. Completion | 2018-05-05 |
| Phase | Phase 4 |
Why NCT03106753 stopped before completion
NCT03106753 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Bupivacaine is the first listed.
NCT03106753 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03106753 about?
NCT03106753 is a clinical study titled "Success of External Cephalic Version Study". The purpose of this study is to determine the best way to optimize the success of external cephalic version (turning the baby from the outside). Attempting to turn babies in-utero is recommended because it may decrease the risk of needing a cesarean section for abnormal presentation. While the study...
What is the current status of trial NCT03106753?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2017-04-12. Estimated completion is 2018-05-05.
What interventions are being tested in trial NCT03106753?
The interventions under investigation include: Bupivacaine (DRUG), Terbutaline (DRUG).
Who is sponsoring clinical trial NCT03106753?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03106753's enrollment target sits among peer trials
34 1520th of 2000 higher than 473 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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