Clinical trials: Perineum; Rupture
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
Skin Structures and Soft Tissue Infections, Wound Infection
The PLUS Study: Comparison of VicrylPlus® Versus Vicryl® for Repair of Perineal Tears
INTRODUCTION It is estimated that over 80% of women who give vaginal birth will sustain some form of perineal tear and of these 60-70% will require suturing.
- Trial name
- NCT02863874
- Testing
- VicrylPlus®, Vicryl®
- Where
- Sweden
- Volunteers
- 1,890 people
- Sponsor
- Region Skane
Perineal Tear, Episiotomy Extended by Laceration
Pushing and Manual Perineal Protection Techniques
Perineal trauma during vaginal delivery is very common, especially in countries with a high prevalence of episiotomy. Perineal traumas can range from tears limited to the skin, subcutaneous and vaginal mucosa to severe tears…
- Conditions
- Perineal Tear, Episiotomy Extended by Laceration, Labor Complication
- Trial name
- NCT04823598
- Testing
- Coached pushing and Finnish manual perineal protection, Uncoached pushing and Hands-poised perineal protection
- Where
- Turkey (Türkiye)
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Istinye University
Pelvic Floor, Perineal Rupture
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
The mechanical demands placed on the pelvic floor structures during vaginal delivery often exceed physiological tissue limits, resulting in maternal childbirth trauma, considerable postpartum morbidity, and increased risk of…
- Conditions
- Pelvic Floor, Perineal Rupture, Obstetric Trauma
- Trial name
- NCT03883867
- Where
- 3 sites in United States, Czechia
- Volunteers
- 20 people
- Sponsor
- Advanced Tactile Imaging, Inc.
Wound; Perineal Rupture, Dehiscence
Early Resuturing Versus Expectant Management Following Perineal Wound Dehiscence Among Women Who Had a Vaginal Delivery
Women who deliver their baby vaginally often suffer from a perineal wound. The wound is after being sutured sometimes dehisced after days up to a few weeks and this study will investigate whether it is better to resuture early or…
- Trial name
- NCT03806348
- Testing
- Resuturing
- Where
- Sweden
- Volunteers
- 140 people
- Sponsor
- Stockholm South General Hospital
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
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
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
PPROM, Preterm Premature Rupture of Membrane
Trans-perineal Ultrasound in Assessment of PPROMs
Accurate and timely diagnosis of preterm pre-labor rupture of membranes (PPROM) is important to prevent adverse maternal and fetal outcomes.
- Trial name
- NCT06443788
- Testing
- transperineal ultrasound
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Ain Shams University
Sphincter (Anal); Perineal Rupture, Obstetric
Development and Validation of a Logistic Regression Algorithm to Predict the Risk of Obstetric Anal Sphincter Injury.
An obstetric anal sphincter injury (OASI) occurs during the final stage of a vaginal delivery. This tissue laceration, even if adequately sutured, poses a substantial threat to bowel continence in women.1,2 In a recent…
- Trial name
- NCT05218837
- Testing
- Vaginal birth
- Where
- Sweden
- Volunteers
- 800,000 people
- Sponsor
- Maria Gyhagen
Dyspareunia, Urinary Incontinence
The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function.
Perineal injury is the most common maternal obstetric complication associated with vaginal delivery (1). It is estimated that perineal lacerations of first and second degree occur in 38% of spontaneous vaginal deliveries in…
- Conditions
- Dyspareunia, Urinary Incontinence, Perineal Tear, Perineal Injury
- Trial name
- NCT05282160
- Testing
- Epino
- Where
- Brazil
- Volunteers
- 70 people
- Sponsor
- Universidade Estadual de Londrina
Puerperal Infection
Prophylactic Antibiotic After Perineal Tear
Current World Health Organization guidelines recommend routine antibiotic prophylaxis for women with perineal tear 3rd and 4th degree but not for 2nd degree because of insufficient evidence of effectiveness.
- Trial name
- PATPET (NCT04763486)
- Testing
- Cefazolin (Cefamezin)
- Where
- Israel
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Meir Medical Center
Post-partum Perineal Pain, Episiotomy
Post-partum Perineal Pain - Chirocaine®
The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree tear.
- Conditions
- Post-partum Perineal Pain, Episiotomy, Vaginal Tear
- Trial name
- EPISIO (NCT02905695)
- Testing
- Chirocaine
- Where
- France
- Volunteers
- 110 people
- Sponsor
- Hopital Foch
Perineal Tear Resulting From Childbirth
Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial
The perineal body is commonly injured during labor. It is possible to perform a secondary repair, a perineorraphy, which aims to reduce the symptomatology after an improperly healed perineal tear.
- Trial name
- NCT02545218
- Testing
- Perineorraphy, Pelvic floor exercise
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Stockholm South 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
Perineal Tear
A Device Designed to Protect the Perineum During Labor
Objective: To investigate the protective effects of a newly invented device for reducing tears in the perineum during vaginal childbirth.
- Trial name
- NCT01533467
- Testing
- Perineal protection device
- Where
- Sweden
- Volunteers
- 1,200 people
- Sponsor
- Helsingborgs Hospital
Perineum; Tear
Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears
There is a controversy regarding whether warm compresses influence the rate of intact perineum after a vaginal delivery. According to a meta-analysis published in 2019 that included 7 randomized prospective trials, approximately…
- Trial name
- NCT05851170
- Testing
- The use of warm compresses and almond oil on the perineum during second stage, Use of almond oil use (routine care) during second stage
- Where
- Israel
- Volunteers
- 412 people, healthy volunteers welcome
- Sponsor
- Western Galilee Hospital-Nahariya