Clinical trials: Perineal Trauma, 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
Obstetric Labor Complications, Obstetric Trauma
Prelabor Visual Biofeedback by a Self-operated Ultrasound Device
A substantial number of women report fear of childbirth and negative birth experiences. The objective of the study is to assess the efficacy of visual biofeedback before labor using a self-operated home ultrasound for maternal…
- Trial name
- NCT06049784
- Testing
- Visual Biofeedback using self operated home ultrasound device, Visual Biofeedback using ultrasound at hospital
- Where
- Israel
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Rabin Medical Center
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, 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
Perineal Injury, Pain Vulva
Improving Postoperative Recovery: A Study of Multimodal Perineal Analgesia Protocol (MPAP) After Vaginal Surgery
The purpose of this research is to determine if using perineal ice packs, medicated witch-hazel pads (MAJOR® Medi-Pads), and topical benzocaine spray (Dermoplast®) helps reduce perineal pain after perineorrhaphy and/or posterior…
- Conditions
- Perineal Injury, Pain Vulva, Perineum; Injury
- Trial name
- NCT07401134
- Testing
- Perineal ice packs, medicated witch-hazel pads, and topical benzocaine spray
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- University of Miami
Postpartum Perineal Pain
AI-Supported Video Education in Episiotomy Care
Although the postpartum period is generally considered a positive experience, obstetric interventions such as episiotomy may lead to significant maternal health problems.
- Trial name
- NCT07453979
- Testing
- Control, AI-Assisted Episiotomy Care Video Group
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Burdur Mehmet Akif Ersoy University
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 Muscle Dysfunction
HIFEM in Pospartum (High Intensity Focused Electro-Magnetic Technology)
The goal of this non-randomized community clinical trial is to test how effective HIFEM (High Intensity Focused Electromagnetic) technology (BTL Emsella) is in strengthening pelvic floor muscles.
- Trial name
- HIFEM (NCT07528560)
- Testing
- HIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Institut Investigacio Sanitaria Pere Virgili
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
Postpartum Quality of Life, Peripartal Maternal Trauma
Improving Postpartum Quality of Life Through Enhanced Perineal Care Training
This prospective interventional before and after study evaluates whether structured obstetric training-covering perineal protection, improved episiotomy technique, systematic detection of obstetric anal sphincter injuries (OASI)…
- Trial name
- NCT07865065
- Testing
- Obstetric training
- Where
- Czechia
- Volunteers
- 380 people
- Sponsor
- University Hospital Hradec Kralove
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
Pain, Perineal Healing
Low-level Laser Therapy in Pain and Perineal Healing in the Immediate Postpartum Period: a Randomized Clinical Trial.
This randomized clinical trial aims to evaluate the effectiveness of low-level laser therapy compared with sham treatment on pain intensity and perineal wound healing quality in the immediate postpartum period.
- Trial name
- LaserPerineal (NCT07480083)
- Testing
- low-level laser therapy
- Where
- Brazil
- Volunteers
- 206 people
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
Bowel Cleansing Prior to Clinical Procedures, Colorectal Anastomosis
Oral Antibiotics vs. No Antibiotics in Pediatric Colorectal Surgery
This study aims to evaluate whether giving oral antibiotics before elective colorectal surgery can improve recovery and reduce complications in children.
- Trial name
- PEACO (NCT07713433)
- Testing
- oral antibiotics, No Oral Antibiotics
- Where
- Pakistan
- Volunteers
- 74 people
- Sponsor
- Muhammad Zubair Shoukat
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
Perineal Injury, Pain
Epsom Salt Compresses to Relieve Perineal for Postpartum Care: a Clinical Trial
The goal of this clinical trial is to determine if topical application of compresses soaked in 25% magnesium sulfate on painful perineum after birth is effective to alleviate pain.
- Trial name
- NCT06393608
- Testing
- Epsom salt, Water
- Where
- 4 sites in Canada
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Antoine Roger
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
Pregnancy Related, Pelvic Floor Disorders
Perineal Massage Using A Pelvic Wand During Pregnancy
There is limited research on the optimal strategy to reduce obstetric laceration, postpartum urinary retention, and postpartum pelvic pain.
- Conditions
- Pregnancy Related, Pelvic Floor Disorders, Obstetric; Injury, Patient Empowerment
- Trial name
- NCT06986824
- Testing
- Pelvic wand
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- Beth Israel Deaconess Medical Center