Clinical trials: Perineum; Wound
Rectal Cancer, Anal Canal Cancer
"Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection
How to reduce the complications of perineal wound after abdominoperineal resection (APR) has always been a hot topic in the medical field.To reduce the complications of perineal wound and the primary healing of perineal wound…
- Trial name
- CCRPWAR (NCT03731754)
- Testing
- Traditional Closure, "Cross" closure
- Volunteers
- 346 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Perineum; Injury, Episiotomy Wound
Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration And Episiotomy
Virtual Reality will be used to decrease anxiety and pain during suturing of episiotomy and perineal lacerations
- Conditions
- Perineum; Injury, Episiotomy Wound, Anxiety
- Trial name
- NCT04693013
- Testing
- Virtual Reality for Anxiety Reduction
- Where
- Israel
- Volunteers
- 84 people
- Sponsor
- Ziv Hospital
Perineal Trauma, Episiotomy
Effect of Boric Acid Wet Dressing on Postpartum Perineal Healing and Pain
Perineal trauma, including episiotomy and first- or second-degree perineal tears, is a common postpartum condition associated with pain and delayed wound healing after vaginal birth.
- Conditions
- Perineal Trauma, Episiotomy, Episiotomy Wound, Perineal Pain
- Trial name
- NCT07748182
- Testing
- 2% Boric Acid Wet Dressing, 0.9% Normal Saline Wet Dressing, Routine Care Group
- Where
- Turkey (Türkiye)
- Volunteers
- 91 people
- Sponsor
- Saglik Bilimleri Universitesi
Perineum; Wound
Postnatal Perineal Wound Assessment
Around 85% of women who give birth vaginally experience a perineal wound, which could be a tear or an incision between the vaginal opening and the anus.
- Trial name
- NCT06551493
- Testing
- Observation of postnatal wound assessment, Interview
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Oxford Brookes University
Obstetric Trauma
Incidence of Obstetric Anal Sphincter Injuries After a Protection Training
This is a retrospective cohort study. This two cohort study seeks to compare the incidence of obstetric anal sphincter injuries (OASIS) in two time periods, before and after an educational workshop for improved perineal support.
- Trial name
- NCT02952404
- Testing
- Educational workshop
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- TriHealth Inc.
Episiotomy Wound
Relaxation Exercise With Virtual Reality Glasses and Episiotomy-induces Perineal Pain and Fear
The aim of this clinical study is to compare the pain and fear scores of women who gave birth for the first time and who did and did not do relaxation exercises with virtual reality glasses during episiotomy incision and…
- Trial name
- NCT05955716
- Testing
- Virtual reality glasses
- Where
- Turkey (Türkiye)
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Özlem Çiçek
Perineal Laceration Involving Skin, Delivery; Trauma
Perineal Body Length and Perineal Lacerations
The aim of this study was to evaluate the relationship between perineal body length and perineal laceration risk in primigravid patients.
- Trial name
- NCT03880552
- Testing
- Primigravid women with singleton pregnancy at 35th week over
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
Heat Therapy, Perineal Tear
The Effect of Using Perineal Warm Compress Techniques During the Second Stage of Labor on Perineal Outcomes
The goal of the clinical trial is to determine the effect of second-stage warm compress application on perineal pain and trauma among primiparous women.
- Conditions
- Heat Therapy, Perineal Tear, Pain, Labor
- Trial name
- NCT05955352
- Testing
- Perineal warm compression Technique
- Where
- Nepal
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Tribhuvan University, Nepal
Obstetrical Perineal Injury and Anal Incontinence
Pelvic-perineal Disorders in Women With Sphincter Tears
According to INSEE, in 2016, in France, there were 785,000 births. According to the latest national perinatal survey in 2016, 80.4% of women gave birth by vaginal delivery.
- Trial name
- PAPOASI (NCT04862299)
- Where
- France
- Volunteers
- 86 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Neuralgia, Perineal
Promoting Optimal Healing After Laceration Repair Study
The goal of this research is to investigate three different methods of perineal skin closure during second-degree perineal wound repair and determine which method is associated with the least amount of patient pain.
- Trial name
- PALS (NCT02055794)
- Testing
- Suturing of the perineal skin, Closing perineal skin with surgical glue, No suturing of the perineal skin
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Perineal Laceration, Tear, or Rupture During Delivery
Study on Fewer Tears (SOFT) - The Effect of Local Anesthesia on the Incidence of Perineal Tears in the First Vaginal Birth
The SOFT study investigates whether local anaesthesia during the second stage of labor decreases the incidence of perineal tears, including sphincter injuries, in women with their first vaginal birth (non-instrumental).
- Trial name
- SOFT (NCT07499752)
- Testing
- Perineal protection techniques
- Where
- Sweden
- Volunteers
- 1,350 people
- Sponsor
- Karolinska Institutet
Pelvic Floor Disorders, Pelvic Floor; Incompetency
Postpartum Pelvic Floor Workshop
After having a baby, there are some expected changes in pelvic floor function. However, tearing of the pelvic floor, having a large baby and needing a vacuum or forceps to deliver the baby put women at risk for having pelvic…
- Conditions
- Pelvic Floor Disorders, Pelvic Floor; Incompetency, Pelvic Floor Muscle Weakness, Perineum; Injury
- Trial name
- PPFW (NCT04754984)
- Testing
- Pelvic floor workshop
- Where
- 2 sites in Canada
- Volunteers
- 100 people
- Sponsor
- Hamilton Health Sciences Corporation
Delivery; Injury, Maternal
Digital Perineal Massage and Pelvic Floor Muscle Exercise During Pregnancy for Prevention of Perineal Laceration
Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage.
- Trial name
- NCT03108170
- Testing
- perineal massage program, Pelvic floor muscle exercise program, Educational pelvic floor dysfunction prevention program
- Where
- Egypt
- Volunteers
- 90 people
- Sponsor
- Cairo University
Perineal Tear and Episiotomy
The Effect of Mucogyne® Gel on Wound Healing
The aim of this post-market clinical follow up study is to confirm the efficacy and safety of topical application of Mucogyne® gel in the process of wound healing, when used in accordance with its approved labeling, in the…
- Trial name
- ARTHEMIS (NCT05888194)
- Testing
- Mucogyne® gel
- Where
- 3 sites in France
- Volunteers
- 118 people
- Sponsor
- Biocodex
Pain, Perineal Healing
Low-level Laser Therapy in Pain and Perineal Healing in the Immediate Postpartum Period: a Randomized Clinical Trial.
This randomized clinical trial aims to evaluate the effectiveness of low-level laser therapy compared with sham treatment on pain intensity and perineal wound healing quality in the immediate postpartum period.
- Trial name
- LaserPerineal (NCT07480083)
- Testing
- low-level laser therapy
- Where
- Brazil
- Volunteers
- 206 people
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
Dehiscence Wound, Secondary Perineal Tear
Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour
The goal of this observational study is to make us more aware of the short and long-term outcomes for women having an uncomplicated healing process after a rupture or birth cut in the perineum after giving birth in relation to a…
- Conditions
- Dehiscence Wound, Secondary Perineal Tear, Episiotomy; Dehiscence
- Trial name
- HEAL (NCT06026423)
- Testing
- Clinical examination and pictures, Questionnaire
- Where
- Denmark
- Volunteers
- 302 people, healthy volunteers welcome
- Sponsor
- Herlev Hospital
Perineal Tear, Perineum; Rupture
Vocalization for the Second Stage of Labor (VOCAL)
A randomized open-label trial will be conducted to evaluate the effect of vocalization as a perineal protection maneuver during the second period of labor.
- Trial name
- VOCAL (NCT03605615)
- Testing
- vocalization
- Where
- Brazil
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
Pain
Continuous Versus Interrupted Sutures for Repair of Episiotomy or Second Degree Tears: a Randomised Controlled Trial
The best technique for this repair would be that which requires least time in realisation, least consumption of material for the repair and that which produces less pain at short and long-term permitting the resumption of…
- Trial name
- NCT00777270
- Testing
- repair of episiotomy or second degree tears
- Where
- Spain
- Volunteers
- 445 people
- Sponsor
- Hospital Universitario Principe de Asturias
Childbirth
A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth
This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device.
- Trial name
- NCT06698185
- Testing
- Materna Prep Device
- Where
- United States
- Sponsor
- Materna Medical
Pelvic Floor Muscle Dysfunction
HIFEM in Pospartum (High Intensity Focused Electro-Magnetic Technology)
The goal of this non-randomized community clinical trial is to test how effective HIFEM (High Intensity Focused Electromagnetic) technology (BTL Emsella) is in strengthening pelvic floor muscles.
- Trial name
- HIFEM (NCT07528560)
- Testing
- HIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Institut Investigacio Sanitaria Pere Virgili