Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428812
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-15
Brief Title:
The Effect of Perineal Protective Package Application on Pelvic Floor in Labor
Sponsor:
Öznur Hayat Öktem
Organization:
Gulhane School of Medicine
Study Overview
Official Title:
Phd Student Msc Midwife
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
This study aimed to evaluate the effect of perineal protection package application on labor outcomes perineal integrity postpartum urinary incontinence and pelvic floor muscle strengthIn this study a package including practices that have been proven to protect the perineum in labor was created and it was aimed to examine the effect of this perineal protection package as a whole Theperineal protective package applications created by the researchers consisted of positioning on the gynecologic table the back of the table was erected the legs were removed from the hooks and placed on the sides of the table open glottis pushing instead of closed glottis pushing hot compress protection of the perineum instead of dry compress protection of the perineum instead of lithotomy position in the second stage which reduces the tension of the perineum and allows it to be observed and protected manually
Detailed Description:
The pelvic floor plays a critical and important role in maintaining healthy functions of the urinary genital and gastrointestinal systems When tissues in a region of the pelvic floor are damaged for any reason pelvic floor dysfunction develops
Pregnancy and childbirth are important risk factors for pelvic floor dysfunction Hormonal and mechanical changes during pregnancy predispose to impaired pelvic floor function During pregnancy weight gain and increase in uterine weight increase intra-abdominal pressure Therefore ligaments and pelvic floor muscles are overstretched He states that the main factor in pelvic floor dysfunction is vaginal delivery and that the passage of a particularly large fetal head through the birth canal is the trigger During the passage and descent of the fetal head through the vaginal canal the pelvic floor muscles can be overstretched torn or damaged Obstetric factors that cause pelvic floor damage include early or late age at first birth high body mass index large baby length of the second stage of trauma labor forceps vacuum episiotomy and fundal compression
Damage to the pelvic floor during labor has many short- and long-term effects on a woman39s quality of life These can be summarized as chronic perineal pain pelvic organ prolapse urinary and anal incontinence fistula sexual dysfunction labor dissatisfaction physical and psychological morbidities and decreased quality of life In addition breastfeeding and mother-infant attachment problems may also occur due to perineal pain in the early postpartum period Therefore it is important to prevent pelvic floor damage in childbirth which negatively affects physical social and psychological well-being and leads to many short and long-term morbidities The World Health Organization recommends the use of techniques such as hot compresses to reduce perineal damage and facilitate spontaneous delivery
In the literature there are many studies examining interventions to protect the pelvic floor in labor Studies show that perineal massage perineal warm application birth positions hand maneuvers pushing techniques and limited episiotomy reduce the incidence of perineal injury
However studies on these techniques and practices are generally studies investigating the effectiveness of a single method In a recent qualitative study midwives were asked to evaluate the effect of some protective practices called perineal package as a whole However in this study midwives own practices and opinions were evaluated and their effects on the pelvic floor or labor were not examined International organizations recommend the application of evidence-based perineal and pelvic floor supportive and protective methods to pregnant women in labor However the relationship between these practices and postpartum pelvic floor muscle strength and the presence of incontinence which are indicators of pelvic floor damage is unclear and studies to evaluate this relationship are limited
The research will be conducted in 4 stages In Phase 1 pregnant women who meet the inclusion criteria will be interviewed when they are admitted to the delivery room In the first interview the relevant sections of the data collection form will be filled out pelvic floor muscle strength will be measured with a perineometer and the IIQ-7 and UDI-6 scales will be filled out Pregnant women with incontinence detected in these scales will be excluded Then pregnant women will be randomized using the true random number generation method on the randomorg website and assigned to the study and control groups Then the delivery process of all pregnant women in the study and control groups will be monitored and recorded using the relevant section of the data collection form
In phase 2 the perineal pain felt by pregnant women in both groups will be evaluated using VAS when the second stage of labor begins The second stage of labor is the time from complete dilatation of the cervix until the fetal head is born During this stage the study group will receive a perineal protection package while the control group will receive routine care Postpartum perineal pain episiotomy length if episiotomy was applied and perineal length will be measured in both groups The results of the trauma will be recorded in the labor follow-up form
In the 3rd stage pregnant women in both groups will be interviewed at the 1st hour postpartum and perineal pain will be evaluated with VAS
In the 4th stage the pregnant women in the study and control groups will be measured pelvic muscle strength with a perineometer perineal length will be measured and recorded on the relevant form during routine hospital control at the 6th week postpartum UDI-6 urinary distress inventory and IIQ-7 incontinence impact questionnaire will be completed
Pregnancy and childbirth are important risk factors for pelvic floor dysfunction Hormonal and mechanical changes during pregnancy predispose to impaired pelvic floor function During pregnancy weight gain and increase in uterine weight increase intra-abdominal pressure Therefore ligaments and pelvic floor muscles are overstretched He states that the main factor in pelvic floor dysfunction is vaginal delivery and that the passage of a particularly large fetal head through the birth canal is the trigger During the passage and descent of the fetal head through the vaginal canal the pelvic floor muscles can be overstretched torn or damaged Obstetric factors that cause pelvic floor damage include early or late age at first birth high body mass index large baby length of the second stage of trauma labor forceps vacuum episiotomy and fundal compression
Damage to the pelvic floor during labor has many short- and long-term effects on a woman39s quality of life These can be summarized as chronic perineal pain pelvic organ prolapse urinary and anal incontinence fistula sexual dysfunction labor dissatisfaction physical and psychological morbidities and decreased quality of life In addition breastfeeding and mother-infant attachment problems may also occur due to perineal pain in the early postpartum period Therefore it is important to prevent pelvic floor damage in childbirth which negatively affects physical social and psychological well-being and leads to many short and long-term morbidities The World Health Organization recommends the use of techniques such as hot compresses to reduce perineal damage and facilitate spontaneous delivery
In the literature there are many studies examining interventions to protect the pelvic floor in labor Studies show that perineal massage perineal warm application birth positions hand maneuvers pushing techniques and limited episiotomy reduce the incidence of perineal injury
However studies on these techniques and practices are generally studies investigating the effectiveness of a single method In a recent qualitative study midwives were asked to evaluate the effect of some protective practices called perineal package as a whole However in this study midwives own practices and opinions were evaluated and their effects on the pelvic floor or labor were not examined International organizations recommend the application of evidence-based perineal and pelvic floor supportive and protective methods to pregnant women in labor However the relationship between these practices and postpartum pelvic floor muscle strength and the presence of incontinence which are indicators of pelvic floor damage is unclear and studies to evaluate this relationship are limited
The research will be conducted in 4 stages In Phase 1 pregnant women who meet the inclusion criteria will be interviewed when they are admitted to the delivery room In the first interview the relevant sections of the data collection form will be filled out pelvic floor muscle strength will be measured with a perineometer and the IIQ-7 and UDI-6 scales will be filled out Pregnant women with incontinence detected in these scales will be excluded Then pregnant women will be randomized using the true random number generation method on the randomorg website and assigned to the study and control groups Then the delivery process of all pregnant women in the study and control groups will be monitored and recorded using the relevant section of the data collection form
In phase 2 the perineal pain felt by pregnant women in both groups will be evaluated using VAS when the second stage of labor begins The second stage of labor is the time from complete dilatation of the cervix until the fetal head is born During this stage the study group will receive a perineal protection package while the control group will receive routine care Postpartum perineal pain episiotomy length if episiotomy was applied and perineal length will be measured in both groups The results of the trauma will be recorded in the labor follow-up form
In the 3rd stage pregnant women in both groups will be interviewed at the 1st hour postpartum and perineal pain will be evaluated with VAS
In the 4th stage the pregnant women in the study and control groups will be measured pelvic muscle strength with a perineometer perineal length will be measured and recorded on the relevant form during routine hospital control at the 6th week postpartum UDI-6 urinary distress inventory and IIQ-7 incontinence impact questionnaire will be completed
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