Clinical trials: Perineum; Rupture
Parturition
Perineal Echography in the Delivery Room for the Detection of Anal Lesions
The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive…
- Trial name
- OASIS 1 (NCT01320995)
- Testing
- Perineal ultrasound
- Where
- 2 sites in France
- Volunteers
- 111 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Perineal Tear
Effectiveness of Warm Packs, Perineal Massage and Hands Off During Labour in the Perineal Outcomes.
This study evaluates the effectiveness of warm packs, perineal massage and hands off, during labour, in the perineal outcomes. The perineal outcomes are perineal tears, grade of perineal tears, need of suture, perineal edema…
- Trial name
- NCT02588508
- Testing
- Warm packs, Perineal massage
- Where
- Brazil
- Volunteers
- 201 people
- Sponsor
- Universidade Federal de Pernambuco
Perineal Pain, Birth Satisfaction
The Effect of Birth Ball and Perineal Massage on Perineal Pain, Perineal Trauma and Birth Satisfaction
One of the important causes of perineal trauma is perineal tension. By reducing this tension, perineal trauma can be prevented. Perineal trauma is a birth complication that can be prevented with midwifery approaches.
- Conditions
- Perineal Pain, Birth Satisfaction, Perineal Laceration, Tear, or Rupture During Delivery
- Trial name
- NCT06935643
- Testing
- Birth Ball, Perineal Massage, Control Group
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
Vaginal Delivery, Perineal Tear Resulting From Childbirth
Comparison of Finnish and Viennese Techniques for Perineal Protection in Women During the Second Stage of Labor
The goal of this clinical trial is to find out which method of protecting the perineum during childbirth works better in reducing tears in first-time mothers.
- Trial name
- NCT07537842
- Testing
- Finnish Manual Perineal Protection Technique, Viennese Manual Perineal Protection
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Nishtar Medical University
Urinary Incontinence, Postpartum
Efficacy of Physiotherapy for Urinary Incontinence in Women With a Puborectalis Avulsion
Childbirth is a major risk factor for pelvic floor muscle (PFM) trauma. In one third of women, stretching of the PFM will result in an avulsion injury (i.e.
- Conditions
- Urinary Incontinence, Postpartum, Pelvic Floor; Perineal Rupture, Obstetric, Physiotherapy
- Trial name
- NCT03254355
- Testing
- Multimodal physiotherapy
- Where
- Canada
- Volunteers
- 126 people
- Sponsor
- Université de Sherbrooke
Perineal Trauma
Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
This is a single-center, prospective, non-randomized post-market clinical follow-up study evaluating the implementation and clinical performance of ASISU during routine vaginal childbirth.
- Trial name
- ASISU-PMCF (NCT07844005)
- Testing
- Perineal protection device
- Where
- Denmark
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- oasicare ApS
Vaginal Discharge, Perineum; Rupture
Efficacy and Safety of the Application of Local Anaesthetic in Spray to Repair of 1st- 2nd Perineal Lacerations
Randomized controlled trial aimed at evaluating the efficacy and safety of the use of a local anesthetic spray, commonly used in clinical practice as off-label, during the suturing of perineal lacerations in post-partum…
- Conditions
- Vaginal Discharge, Perineum; Rupture, Analgesia
- Trial name
- LISPRAY (NCT05201313)
- Testing
- Lidocaine Hydrochloride, Mepivacaine Injection
- Where
- Italy
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
Perineal Tear, Obstetric Trauma
Short Anovaginal Distance is Associated With Obstetric Anal Sphincter Rupture
Anovaginal distance measured by palpation and perineal ultrasound are similar.
- Trial name
- AVD and OASR (NCT03039582)
- Testing
- Bidigital palpation, Perineal ultrasound
- Volunteers
- 151 people
- Sponsor
- Ostergotland County Council, Sweden
Perineal Tear
The Effect of Neuraxial Morphine (Duramorph) on Pain Control
With the rise of the opioid epidemic, it is important for physicians to be more mindful of the amount of narcotic prescriptions that are being written every day.
- Trial name
- NCT03926559
- Testing
- Morphine.
- Where
- United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Augusta University
Sphincter (Anal); Perineal Rupture, Obstetric, Perineal Tear
One Plus One Equals Two, Will That do?
A new clinical practice to reduce perineal trauma has been adopted by many maternity wards in Sweden. This practice involves collegial midwifery assistance during the second stage of labor and the birth of the baby.
- Conditions
- Sphincter (Anal); Perineal Rupture, Obstetric, Perineal Tear, Pelvic Floor Disorders, Experience, Life
- Trial name
- Oneplus (NCT03770962)
- Testing
- Two midwives
- Where
- 4 sites in Sweden
- Volunteers
- 3,058 people
- Sponsor
- Region Skane
Delivery, Obstetric
Verifying Post-delivery Anal Sphincter Integrity Using Perineal Ultrasound: Impact on Immediate Care
The main objective of this study is to compare post partum rates of anal sphincter rupture (that is to say the rate of sutures) diagnosed in women with ≥ 2nd degree vaginal tears between two groups: (1) women who are screened…
- Trial name
- OASIS 2 (NCT01905644)
- Testing
- Perineal ultrasound
- Where
- 3 sites in France
- Volunteers
- 276 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Sphincter (Anal); Perineal Rupture, Obstetric
Digital Rectal Examination vs Machine Learning-assisted Electrical Impedance Spectroscopy for Obstetric Anal Sphincter Injuries' Detection: a Prospective Cohort Study in Primiparous Women Giving Vaginal Childbirth
The investigator will evaluate the detection rate for Obstetric Anal Sphincter Injuries (OASI) in primiparas having given vaginal childbirth, comparing the sensitivity of methods available in a labour ward setting for rapid…
- Trial name
- NCT07474012
- Testing
- Primiparous women who have completed vaginal delivery will be submitted to a digital rectal examination and an examination with machine learning-assisted electrical impedance spectroscopy
- Volunteers
- 110 people
- Sponsor
- IRCCS San Raffaele
Episiotomy Extended by Laceration
Effect of Perineal Massage on the Frequency of Episiotomy and Perineal Tearing
A randomized controlled trial was conducted at the Department of Obstetrics and Gynaecology, Sheikh Zayed Hospital, Rahim Yar Khan, over 6 months following Institutional Review Board and College of Physicians and Surgeons…
- Trial name
- NCT07374497
- Testing
- Intrapartum perineal massage, Standard Intrapartum Care Group (Control)
- Where
- Pakistan
- Volunteers
- 202 people
- Sponsor
- Sheikh Zayed Medical College
Dyspareunia
Effectiveness of Radiofrequency Combined With Ultrasound for the Treatment of Postpartum Dyspareunia
The objective of this community-based, non-randomized, quasi-experimental study is to assess the effectiveness of BTL EXILIS technology-based on combined radiofrequency and ultrasound-in women of childbearing age from an…
- Trial name
- NCT07504991
- Testing
- Combining radiofrequency and ultrasound. BTL Exilis
- Where
- Spain
- Volunteers
- 34 people
- Sponsor
- Institut Investigacio Sanitaria Pere Virgili
Transperineal Ultrasound, Midwife-led Pushing Training Program
Pushing Using Real-time Sonographic Ultrasound Education
The study aims to assess whether the use of ultrasound during a pushing lesson can facilitate easier and safer childbirth. The research will be conducted at a single hospital and will involve pregnant women in their second…
- Conditions
- Transperineal Ultrasound, Midwife-led Pushing Training Program, Duration of the Second Stage, Coactivation Rates of Pelvic Floor Muscles
- Trial name
- PURSUE (NCT07000240)
- Testing
- Midwife-led ultrasound-guided pushing training group, Midwife-led pushing training only group
- Where
- Italy
- Volunteers
- 136 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Parturition, Delivery, Obstetric
Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth
During childbirth, the recommendations have evolved to a restriction of episiotomy. This reduction results in an increase of superficial vaginal and perineal tears.
- Trial name
- ImSOLENCE (NCT02870712)
- Testing
- Suture of perineum, hemostatis by digital compression
- Where
- France
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Besancon
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
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
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