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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03106753
The ClinicalTrials.gov registry entry for NCT03106753 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bupivacaine is the first listed.
NCT03106753 reports 0 study locations.
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.
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