Clinical trials: Perineal Tear, open to volunteers
Anxiety
An Informative Video About Perineal Tears During Labor for Anxiety Reduction: A Randomized Controlled Trial
This study evaluates the impact of an informative video about perineal tears on maternal anxiety during labor. Perineal trauma during childbirth, especially severe tears such as obstetric anal sphincter injuries (OASIS), is…
- Trial name
- VITAL (NCT07064213)
- Testing
- Behavioral: Educational Video
- Where
- Israel
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Wolfson Medical Center
Perineal Trauma, Postpartum Pain
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal tears and episiotomies are common after vaginal birth and may cause persistent pain, impaired wound healing, pain during sexual activity, and concerns about genital appearance.
- Conditions
- Perineal Trauma, Postpartum Pain, Episiotomy, Perineal Laceration
- Trial name
- RELIEVE (NCT07727213)
- Testing
- Autologous Non-Activated Platelet-Rich Plasma, Saline (0.9%, sterile, for infusion)
- Where
- Switzerland
- Volunteers
- 160 people
- Sponsor
- University Hospital, Geneva
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
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
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
Episiotomy, Lacerations Perineal
Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma
The aim of this study is to assess the effectiveness of a pelvic floor muscle training (PFMT) protocol associated with cryotherapy initiated in the immediate postpartum period in relieving pain in primiparous women who suffered…
- Conditions
- Episiotomy, Lacerations Perineal, Obstetric Anal Sphincter Injury, Perineal Injury
- Trial name
- MPR (NCT07170007)
- Testing
- Physiotherapeutic protocol, Usual maternity care
- Where
- Brazil
- Volunteers
- 82 people
- Sponsor
- University of Sao Paulo
Pelvic Floor Dysfunction, Perineal Laceration
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to determine whether using a soft perineal protection device (BabySlide®) in addition to standard manual perineal support during vaginal delivery can reduce the risk of perineal trauma in…
- Conditions
- Pelvic Floor Dysfunction, Perineal Laceration, Wound Dehiscence, Anal Incontinence
- Trial name
- PeriPROTECT (NCT07862660)
- Testing
- Perineal protection device, BabySlide, Standard manual perineal support
- Where
- Sweden
- Volunteers
- 4,226 people
- Sponsor
- Region Skane
Perineal Trauma, Hands-on Technique
Hands-on vs Hands-off Techniques in Perineal Protection
Perineal tears are frequent during vaginal delivery. This study evaluates the impact of hands-on versus hands-off techniques on perineal and neonatal outcomes to determine the most effective protective strategy.
- Conditions
- Perineal Trauma, Hands-on Technique, Hands-of Technique, Manual Perineal Protection
- Trial name
- MPP (NCT07492940)
- Where
- Italy
- Volunteers
- 737 people
- Sponsor
- Azienda ULSS 8 Berica
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 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
Obstetric Anal Sphincter Injury, Severe Perineal Trauma
CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence
The aim of this study is to ascertain which pathways currently exist in relation to the follow up of patients with obstetric anal sphincter injury related incontinence.
- Conditions
- Obstetric Anal Sphincter Injury, Severe Perineal Trauma, Grade 3 Perineal Tear, Grade 4 Perineal Tear
- Trial name
- CArE for OAsI (NCT06143072)
- Where
- United Kingdom
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- London North West Healthcare NHS Trust
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
Vaginal Laceration During Delivery
Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.
The goal of this observational study is to learn whether different classification systems for second-degree perineal tears can predict postpartum complications in women undergoing spontaneous vaginal childbirth.
- Trial name
- LAC-VAG-2025 (NCT07124676)
- Where
- Italy
- Volunteers
- 482 people
- Sponsor
- University of Campania Luigi Vanvitelli
Obstetric; Injury Pelvic Floor
Perineal Massage During Labor for the Prevention of Perineal Trauma
The purpose of this study is to evaluate whether perineal massage during labor can help prevent perineal trauma, such as lacerations or episiotomies.
- Trial name
- NCT07099690
- Testing
- Perineal massage
- Where
- Brazil
- Volunteers
- 466 people, healthy volunteers welcome
- Sponsor
- Federal University of Rio Grande do Sul