Clinical trials: Vaginal Lacerations
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
Vaginal Lesion
Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?
The main objective of this study is to assess whether the presence of abnormal vaginal flora (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of delivery.
- Trial name
- NCT01822782
- Testing
- Bacteriological analysis of vaginal sample
- Where
- France
- Volunteers
- 1,100 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
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
Pelvic Floor Disorders, Urinary Incontinence
Effects of Epi-no Device on Pelvic Floor Dysfunctions
Perineal injury is the most common maternal obstetric complication associated with vaginal delivery. Perineal traumas are associated with maternal morbidity, including pain, urinary and fecal incontinence, genital prolapses…
- Conditions
- Pelvic Floor Disorders, Urinary Incontinence, Dyspareunia, Lacerations Perineal
- Trial name
- NCT04955418
- Testing
- Epi-No®, Evaluation
- Where
- Brazil
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Universidade Estadual de Londrina
Birth Injuries, Lacerations
Acupuncture for Pain Relief During Perineal Repair After Childbirth
Midwives and obstetricians are currently using acupuncture for several health problems during pregnancy and childbirth. The investigators wish to determine whether acupuncture can be used as pain relief during the repair of…
- Conditions
- Birth Injuries, Lacerations, Pain
- Trial name
- NCT00328796
- Testing
- acupuncture in 6 specific points, lidocaine 10mg/ml
- Where
- Denmark
- Volunteers
- 207 people
- Sponsor
- Sonderborg 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
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 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
Perineal Lacerations, Delivery, Obstetric
Photobiomodulation for Episiotomies and Perineal Lacerations After Vaginal Delivery.
Episiotomies (EP) and perineal lacerations (PL) following vaginal delivery can lead to complications such as pain, edema, and infection.
- Conditions
- Perineal Lacerations, Delivery, Obstetric, Episiotomy Wound, Photobiomodulation Therapy
- Trial name
- NCT06893315
- Testing
- Photobiomodulation Therapy, Hospital Standard Protocol of treatment for pain and healing
- Where
- Brazil
- Volunteers
- 183 people
- Sponsor
- University of Nove de Julho
Postpartum Hemorrhage, Vaginal Lacerations
Tranexamic Acid for Postpartum Vaginal Laceration Hemorrhage
The necessary information was provided to the patients included in the study and their written consent was obtained.
- Trial name
- NCT07094399
- Where
- Turkey (Türkiye)
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Harran University
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
Vaginal Tear, Perineal Tear
Application of a Perineal Protection Device in Vacuum-assisted Births
Visible birth tears are common in vaginal births, especially in vacuum-assisted births. One aim of obstetrical work is to minimize such injuries by an adequate birth management , for example with a proper perineal support.
- Trial name
- NCT04370340
- Testing
- BabySlide
- Where
- Switzerland
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- University of Zurich
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
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
Tear, Pelvic Organ, Obstetric Trauma
A Pilot Study To Evaluate The Preliminary Safety And Feasibility Of The Materna Medical Device
The Materna device aims to prevent pelvic tissue damage by preventing overstretching of pelvic floor muscle fibers during delivery.
- Trial name
- NCT02332759
- Testing
- Materna Medical
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Pregnancy, Childbirth
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
The goal of this clinical investigation is to learn if training with Emagina device can improve flexibility of the perineum during childbirth with the help of a balloon that inflates in the genital area according to a…
- Trial name
- PeriFlex (NCT06542744)
- Testing
- Training with the Emagina device at home until birth, No intervention
- Where
- 15 sites in France
- Volunteers
- 88 people
- Sponsor
- Mumming
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
Uterovaginal Prolapse, Prolapse of Vaginal Vault After Hysterectomy
Compare Sacrospinous Fixation Versus High Uterosacral Ligament Fixation for Uterus Vaginal Prolapse III/IV
The purpose of this study is to compare the vaginal sacrospinous colpopexy and high uterosacral colpopexy in the treatment of genital prolapse grade III/IV in women with uterus.
- Conditions
- Uterovaginal Prolapse, Prolapse of Vaginal Vault After Hysterectomy, Complete Tear, Sacrospinous Ligament, Uterosacral Ligament; Rupture
- Trial name
- NCT01347021
- Testing
- sacrospinous colpopexy versus high uterosacral colpopexy
- Where
- Brazil
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Federal University of São Paulo
Dyspareunia, Pelvic Pain
Electrolysis Technique vs Manual Therapy in Pelvic Pain
Pelvic floor muscle physical therapy is recommended in clinical guidelines for women dyspareunia and pelvic pain. This study compare pelvic floor manual therapy and intratissue percutaneous electrolysis (EPI) technique in the…
- Conditions
- Dyspareunia, Pelvic Pain, Pelvic Floor Disorders, Musculoskeletal Pain
- Trial name
- NCT03163160
- Testing
- Pelvic floor manual therapy group, Pelvic floor electrolysis group
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Quirón Madrid University Hospital
Surgical Scar Tissue of Cesarean Section or Vaginal Tear or Episiotomy
Low Level Laser Therapy for Better Wound Healing
Prospective randomized double blind study. Intervention 1: Low-level laser therapy ca. 72 Joules vs. Intervention 2: No Low-level laser therapy. Outcome: Pain score \& would healing at discharge, 1 months \& 3 months
- Trial name
- NCT06220786
- Testing
- Low-level laser therapy, "Fake" low-level laser therapy
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- St. Elisabethen Krankenhaus Frankfurt GmbH