Clinical trials: Vaginal Lacerations
Vaginal Tearing
Does the Use of Dianatal Reduce the Rate of Episiotomy and Vaginal Tears in Birth?
The purpose of the study is to see whether the use of DIANATAL during active labor, reduces the rates of episiotomy and vaginal tears.
- Trial name
- NCT02492152
- Testing
- Study group
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Meir Medical Center
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 Lacerations, Episiotomy
Study of Different Suturing Techniques for Perineal Repair After Delivery
We wish to determine wich of two standardized suturing techniques is the best for perineal repair if a perineal laceration or an episiotomy is present after vaginal birth.
- Trial name
- NCT00265421
- Testing
- Suture technique for perineal repair after delivery
- Where
- Denmark
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Perineal Injury, Perineal Laceration, Tear, or Rupture During Delivery
Targeted Deep Pelvic Floor Muscle Physiotherapy Versus Antenatal Perineal Massage in Nulliparous Women
This prospective randomized clinical trial evaluates whether targeted deep pelvic floor muscle physiotherapy is more effective than standard antenatal perineal massage in reducing perineal trauma among nulliparous women.
- Trial name
- NCT07764068
- Testing
- Targeted Deep Pelvic Floor Muscle Physiotherapy, Standard Antenatal Perineal Massage
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Meir Medical Center
Episiotomy; Complications, Scar Tissue
Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue A Pilot RCT
The goal of this Pilot Randomized Control Trial (RCT) is to determine if a larger RCT evaluating the effect of self-scar tissue massage of episiotomy and/or vagina/perineal tear scar tissue on pelvic health outcomes is feasible.
- Conditions
- Episiotomy; Complications, Scar Tissue, Perineal Tear, Vaginal Tear Resulting From Childbirth
- Trial name
- EPIS (NCT05908292)
- Testing
- Pelvic Floor Scar Tissue Self-Scar Massage
- Where
- Canada
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Calgary
Vaginal Laceration During Delivery
The PAIN (Pelvic Area Injection for Numbness) Study
Postpartum pain can interfere with patient's ability to care for themselves, and their newborn, and untreated pain is associated with risk of greater opioid use, postpartum depression, and development of persistent pain.
- Trial name
- PAIN (NCT05972681)
- Testing
- Bupivacaine, Epinephrine
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Second Degree Perineal Tear During Delivery - Delivered, Episiotomy; Complications
Perineal Local Infiltration Study
The prevalence of birth canal lacerations is more than 70% of all deliveries in Canada. The repair of such lacerations is usually done using a pre-existing epidural analgesia.
- Conditions
- Second Degree Perineal Tear During Delivery - Delivered, Episiotomy; Complications, Anesthesia, Local
- Trial name
- PLIS (NCT03672500)
- Testing
- Bupivacaine 0.5%+Epinephrine 50mc
- Where
- Canada
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Sunnybrook Health Sciences Centre
Perineal Laceration, Tear, or Rupture During Delivery
TRESPASS Clinical Study
The purpose of this study is to assess the superiority of a standardized perineal massage in the decrease in vagino-perineal lacerations.
- Trial name
- NCT06443736
- Testing
- Standardized perineal massage, Primary prevention
- Where
- Italy
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
Perineal Tear, Delivery; Trauma
The Patient Positioning for Perineal Protection Study
It is common practice for practitioners to instruct patients to forcibly flex the hips at the time of delivery of the fetal vertex.
- Conditions
- Perineal Tear, Delivery; Trauma, Perineal Laceration
- Trial name
- 4P (NCT04616170)
- Testing
- Hip extension, Usual Care
- Where
- United States
- Volunteers
- 1,206 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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
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
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
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 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
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
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
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