Ignite Creation Date:
2024-05-06 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03106753
Status:
TERMINATED
Last Update Posted:
2020-10-09
First Post:
2017-03-27
Brief Title:
Success of External Cephalic Version Study
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Success of External Cephalic Version With Immediate Spinal Anesthesia Versus Spinal Anesthesia When Attempt Without Anesthesia Has Failed A Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis to assess concern for spinal anesthesia and increased cesarean delivery rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Breech presentation occurs in approximately 3-4 of term pregnancies and leads to one of the most common indications for cesarean delivery Attempting an external cephalic version ECV significantly increases the chance of cephalic presentation at time of delivery and reduces the chance of cesarean section Since ECV does in fact reduce the rate of cesarean section many studies have sought to determine the best method to perform the procedure to optimize the chance of success A recent meta-analysis concluded that administration of neuraxial analgesia significantly increases the success rate of ECV and also increases the incidence of vaginal delivery However there have been only 2 prospective studies and no randomized trials that evaluated the success of ECV using neuraxial analgesia only when initial attempt without it has failed Therefore the study team designed a randomized controlled trial with two groups Group 1- patients receiving spinal anesthesia immediately versus Group 2- patients attempting ECV without spinal anesthesia with reattempt using a spinal if first attempt fails This study will be conducted on labor and delivery at Mount Sinai West hospital Patients who present to labor and delivery at term for ECV will be approached for enrollment and those who consent to be part of the study would be randomized into a group ECV will then be attempted and delivery and neonatal outcomes will be collected Patients will likely be enrolled in the study from time of version approximately 37 weeks until postpartum This study will take approximately 1-2 years given the ECV rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None