Clinical trials: Perineal Trauma
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 Trauma, Episiotomy
Effect of Boric Acid Wet Dressing on Postpartum Perineal Healing and Pain
Perineal trauma, including episiotomy and first- or second-degree perineal tears, is a common postpartum condition associated with pain and delayed wound healing after vaginal birth.
- Conditions
- Perineal Trauma, Episiotomy, Episiotomy Wound, Perineal Pain
- Trial name
- NCT07748182
- Testing
- 2% Boric Acid Wet Dressing, 0.9% Normal Saline Wet Dressing, Routine Care Group
- Where
- Turkey (Türkiye)
- Volunteers
- 91 people
- Sponsor
- Saglik Bilimleri Universitesi
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
Perineal Trauma, Ritgen Maneuver
Ritgen Maneuver and Birth-Related Perineal Trauma: RCT
Perineal trauma is one of the common complications that may occur during the second stage of labor and can negatively affect women's postpartum recovery and quality of life.
- Trial name
- NCT07713173
- Testing
- Ritgen maneuver, Routine Care Group
- Where
- Turkey (Türkiye)
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Medipol University
Perineal Trauma, Obstetric Anal Sphincter Injury
Papaverine for Prevention of Perineal Trauma
Perineal trauma is a common complication of vaginal delivery, particularly among primiparous patients, and may result in short- and long-term maternal morbidity, including pain, dyspareunia, and pelvic floor dysfunction.
- Trial name
- NCT07641543
- Testing
- Papaverine Hydrochloride
- Volunteers
- 412 people
- Sponsor
- Dr Raneen Abu Shqara
Perineal Trauma
Effect of Nursing Care Bundle Upon Perineal Trauma Reduction and Birth Outcomes During Vaginal Birth
This study aimed to evaluate the effect of implementing a nursing care bundle upon perineal trauma reduction and birth outcomes during vaginal birth. A quasi-experimental design was employed.
- Trial name
- NCT07505524
- Testing
- nursing care bundle
- Where
- Palestinian Territories
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Al-Quds University
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
Pelvic Floor Disorders, Urinary Incontinence
Maternal Musculoskeletal Factors of the Hip, Lumbopelvic, Abdominal and Pelvic Floor Regions and Their Association With Mode of Delivery and Postpartum Pelvic Floor Dysfunction
This prospective observational cohort study aims to investigate the association between maternal musculoskeletal factors of the hip, lumbopelvic, abdominal, and pelvic floor regions and childbirth outcomes, as well as their…
- Conditions
- Pelvic Floor Disorders, Urinary Incontinence, Perineal Trauma, Pelvic Floor Dysfunction
- Trial name
- NCT07478159
- Testing
- Maternal Musculoskeletal Assessment
- Volunteers
- 376 people, healthy volunteers welcome
- Sponsor
- Universitat Internacional de Catalunya
Maternal Pushing Techniques, Perineal Trauma
Vocalization and Spontaneous Pushing in the Second Stage of Labor
The second stage of labor, defined as the period from full cervical dilatation to fetal birth, is a critical phase in which maternal pushing techniques may significantly affect maternal and neonatal outcomes (1-5).
- Conditions
- Maternal Pushing Techniques, Perineal Trauma, Maternal Fatigue, Labor
- Trial name
- NCT07316348
- Testing
- The vocalization straining technique will be used.
- Where
- Turkey (Türkiye)
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
Perineal Trauma, Pelvic Floor Dysfunction
Pelvic Floor Training Program and Perineal Trauma During Vaginal Birth
This study aims to determine whether a structured pelvic floor muscle training program during pregnancy can reduce perineal trauma during vaginal birth.
- Conditions
- Perineal Trauma, Pelvic Floor Dysfunction, Labor Complications, Pelvic Floor Muscle Training
- Trial name
- PFTP (NCT07292948)
- Testing
- Pelvic Floor Muscle Training Program
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Mehmet Incebıyik
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
Obstetric Complication, Obstetric Trauma
Consequences of Obstetric Anal Sphincter Injuries on Maternal Psychology and Relationship Experience
The aim is to ascertain whether sustaining an Obstetric Anal Sphincter Injury negatively impacts intra-family relationships and increases the risk of mental health conditions, including a women's perception of herself and her…
- Conditions
- Obstetric Complication, Obstetric Trauma, Perineal Tear, Incontinence
- Trial name
- COMPaRE (NCT05935371)
- Where
- United Kingdom
- Volunteers
- 87 people
- Sponsor
- London North West Healthcare NHS Trust
Obstetric Trauma, Perineum; Injury
The Effect of Perineal Wound Infection on the Anal Sphincter
Perineal injury following childbirth can result in complications such as wound infection. The perineum has closely related anatomical structures including the external genital organs and the anal triangle which contains the anal…
- Conditions
- Obstetric Trauma, Perineum; Injury, Perineal Infection, Anal Sphincter Injury
- Trial name
- NCT04480684
- Testing
- Three-dimensional Endoanal Ultrasound, Transperineal Ultrasound(multiplanar), The MolecuLight i:X: Bacterial autofluorescence camera
- Where
- United Kingdom
- Volunteers
- 80 people
- Sponsor
- Croydon Health Services NHS Trust
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.
Perineal Laceration Involving Skin, Delivery; Trauma
Perineal Body Length and Perineal Lacerations
The aim of this study was to evaluate the relationship between perineal body length and perineal laceration risk in primigravid patients.
- Trial name
- NCT03880552
- Testing
- Primigravid women with singleton pregnancy at 35th week over
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
Delivery; Trauma, Pelvic Floor; Perineal Rupture, Obstetric
Perineal Preparation for Pregnant Ladies.
Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage.
- Conditions
- Delivery; Trauma, Pelvic Floor; Perineal Rupture, Obstetric, Pelvic Floor Muscle Weakness
- Trial name
- NCT03287258
- Testing
- 3 program, one program
- Where
- Egypt
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Kasr El Aini Hospital
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