Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272591
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2024-01-15
Brief Title:
Comparison of Patient Satisfaction With Home Induction and In-patient Induction
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Comparison of Patient Satisfaction With Home Induction and In-patient Induction
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Induced labour is a medical intervention designed to initiate or accelerate the childbirth process when clinically indicated
Induced labour concerns 258 of pregnant women in France according to the latest National Perinatal Survey 2021 This rate is rising steadily since in 2016 induction concerned 22 of pregnancies There are many medical indications for induction both maternal and foetal Induced labour in hospitals is beginning to reach its limits given the reduction in the number of nursing staff and the reduction in the number of beds available In some cases patients are hospitalised for 24 to 72 hours before going into labour In this context the place where the birth takes place whether at home or in hospital is essential with a potential impact on patient satisfaction and the experience of induction
Cervical ripening can be a difficult experience for women with a feeling of loss of control at this crucial stage The duration of induction is one of the factors that women would like to see changed when asked about the aftermath of induction The option of inducing at home might seem to improve womens experience and reduce the length of their stay in hospital
Induced labour concerns 258 of pregnant women in France according to the latest National Perinatal Survey 2021 This rate is rising steadily since in 2016 induction concerned 22 of pregnancies There are many medical indications for induction both maternal and foetal Induced labour in hospitals is beginning to reach its limits given the reduction in the number of nursing staff and the reduction in the number of beds available In some cases patients are hospitalised for 24 to 72 hours before going into labour In this context the place where the birth takes place whether at home or in hospital is essential with a potential impact on patient satisfaction and the experience of induction
Cervical ripening can be a difficult experience for women with a feeling of loss of control at this crucial stage The duration of induction is one of the factors that women would like to see changed when asked about the aftermath of induction The option of inducing at home might seem to improve womens experience and reduce the length of their stay in hospital
Detailed Description:
There are generally two main methods of cervical ripening mechanical methods Foley catheter or Cook double balloon catheter and pharmacological methods Propess dinoprostone intravaginal tampon Prostine intravaginal gel or Angusta oral misoprostol
Balloon induction of labour works by the dilating effect of a balloon inflated at the level of the uterine cervix which distinguishes it from pharmacological methods acting via uterine contractions
Balloon induction has been shown to be effective and safe It therefore seems important to take a closer look at this method of outpatient induction especially as the risks of uterine hyperkinesiahypertonia and anomalies in foetal heart rate are very low with this technique
Several foreign studies have looked at outpatient induction of labour Meta-analyses have shown a lower caesarean section rate with outpatient induction faster labour and less administration of oxytocin
In terms of safety a systematic review of the literature based on data from 26 studies published in 2018 showed a low risk of developing adverse effects between insertion and expulsion of the balloon A meta-analysis conducted in 2020 compared inpatient versus outpatient induction of labour showing no significant differences between the home and inpatient groups in terms of major neonatal adverse events In addition several studies have suggested that allowing patients to participate actively in the decision concerning the induction method can promote better understanding and acceptance of the process thereby strengthening their commitment to their own health
The obstetrics and gynecology department of the University hospital recently modified its protocol for the management of induced labour in order to allow a more free and informed choice of technique information booklet reflection period and a return home for low-risk women after balloon insertion
The aim of this work will be to demonstrate a link between womens choice of induction method and increased compliance with their care
The aim of this study is to monitor the implementation of this new service protocol
The aim of the study will be to analyse the experience and satisfaction of women who have undergone induction comparing their experiences at home and in hospital
This research is being carried out in a context in which the choice of induction the methods used and the place of delivery are arousing growing interest in the medical community and among women themselves
Balloon induction of labour works by the dilating effect of a balloon inflated at the level of the uterine cervix which distinguishes it from pharmacological methods acting via uterine contractions
Balloon induction has been shown to be effective and safe It therefore seems important to take a closer look at this method of outpatient induction especially as the risks of uterine hyperkinesiahypertonia and anomalies in foetal heart rate are very low with this technique
Several foreign studies have looked at outpatient induction of labour Meta-analyses have shown a lower caesarean section rate with outpatient induction faster labour and less administration of oxytocin
In terms of safety a systematic review of the literature based on data from 26 studies published in 2018 showed a low risk of developing adverse effects between insertion and expulsion of the balloon A meta-analysis conducted in 2020 compared inpatient versus outpatient induction of labour showing no significant differences between the home and inpatient groups in terms of major neonatal adverse events In addition several studies have suggested that allowing patients to participate actively in the decision concerning the induction method can promote better understanding and acceptance of the process thereby strengthening their commitment to their own health
The obstetrics and gynecology department of the University hospital recently modified its protocol for the management of induced labour in order to allow a more free and informed choice of technique information booklet reflection period and a return home for low-risk women after balloon insertion
The aim of this work will be to demonstrate a link between womens choice of induction method and increased compliance with their care
The aim of this study is to monitor the implementation of this new service protocol
The aim of the study will be to analyse the experience and satisfaction of women who have undergone induction comparing their experiences at home and in hospital
This research is being carried out in a context in which the choice of induction the methods used and the place of delivery are arousing growing interest in the medical community and among women themselves
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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