Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506721
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
Comparison Between Two Medical Devices for Labor Induction After Previous C-section
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Balloon Catheter vs Hygroscopic Cervical Dilator for Labour Induction After Previous Caesarean Section an Open Prospective Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DiBal
Brief Summary:
The objective of the study ist to compare the Dilapan-S and the Cook Ballon device for the mechanical induction of labour in women with a previous C-section There is currently lack of data regarding this comparison of the two methods for mechanical labour induction in this patient collective Any method used for labour induction is therefore off-label The primary outcome is the time between placement of the device and delivery Ad secondary outcomes are among others the cesarean delivery rate and patient satisfaction with the induction method
Detailed Description:
The cesarean section CS rate is increasing worldwide with previous CS being an important factor contributing to this trend The investigators think that VBAC may be safe provided a careful selection of the patients is performed The individual birth management is particularly important if labour has to be induced as in case of approximately 25 of women attempting VBAC Counselling patients about labour induction can be challenging as they should be offered not only a safe but also an effective method Labor induction can be achieved by using several approaches administration of drugs which induce uterine contractions such as prostaglandins or oxytocin performing an amniotomy or using mechanical methods In Switzerland and implicitly in the investigators institution PGE after CS are rarely employed in carefully selected cases Oxytocin administration after performing amniotomy is considered to be a safe method but may be less effective with an unfavorable BISHOP score 6
An possible alternative in case of unripe cervix is induction of labour by use of mechanical methods balloon catheters and laminaria stents The investigators currently use the double balloon catheter device Cook Inc for this purpose This device is inserted transcervically and both ballons are inflated with sterile 09 saline solution The catheter remains in place until spontaneously expelled or until start of active labour If neither happens it will be removed after 12-24 hours followed by oxytocin administration and amniotomy
Recently an alternative method for mechanical induction is gaining increased attention the use of hygroscopic cervical dilators The method seems to be equally effective and safe as directly compared to a single device catheter in a low risk population of women without uterine scar When used in patients with previous cesarean section the rate of spontaneous labour seems to resemble existent data for induction with balloon catheter this including the investigators collective
One of the advantages of Dilapan-S could be the lack of vaginal protrusion and the fact that it does not have to be fixated under tension Women seem to feel more mobile with Dilapan the perception of relaxation moments between contractions as well as sleep periods during the induction seem to be improved with Dilapan
An possible alternative in case of unripe cervix is induction of labour by use of mechanical methods balloon catheters and laminaria stents The investigators currently use the double balloon catheter device Cook Inc for this purpose This device is inserted transcervically and both ballons are inflated with sterile 09 saline solution The catheter remains in place until spontaneously expelled or until start of active labour If neither happens it will be removed after 12-24 hours followed by oxytocin administration and amniotomy
Recently an alternative method for mechanical induction is gaining increased attention the use of hygroscopic cervical dilators The method seems to be equally effective and safe as directly compared to a single device catheter in a low risk population of women without uterine scar When used in patients with previous cesarean section the rate of spontaneous labour seems to resemble existent data for induction with balloon catheter this including the investigators collective
One of the advantages of Dilapan-S could be the lack of vaginal protrusion and the fact that it does not have to be fixated under tension Women seem to feel more mobile with Dilapan the perception of relaxation moments between contractions as well as sleep periods during the induction seem to be improved with Dilapan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None