Clinical trials: Perineal Trauma
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
Dermatitis, Radiation Induced
Retrospective Analysis of the Efficacy of Morphine Gel to Treat Pain Associated With Perineal RadioDermatitis
Retrospective study evaluating the efficacy of a pharmacy-prepared Morphine gel used in clinics for the treatment of pain associated with perineal radiodermatitis.
- Trial name
- ANTAGEL (NCT07207889)
- Testing
- morphine chlorhydrate in intrasite gel
- Where
- France
- Volunteers
- 17 people
- Sponsor
- Institut Curie
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
Onset of Perineal Wound Infection
Delayed vs Early Enteral Feeding After Anterior Sagittal Anorectopexy
to study the effect of early vs delayed enteral feeding following ASARP in females with congenital recto-vestibular fistula
- Trial name
- NCT05297916
- Testing
- enteral feeding
- Where
- Egypt
- Volunteers
- 55 people
- Sponsor
- Tanta University
Perineal Wound Complications After ELAPE
Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following ELAPE
Perineal wound healing is a significant challenge after extralevator abdominoperineal excision (ELAPE) due to a high rate of wound breakdown.
- Trial name
- NCT04033484
- Testing
- Negative Pressure Wound Therapy
- Where
- China
- Volunteers
- 66 people
- Sponsor
- Beijing Chao Yang Hospital
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
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 Extended by Laceration
Effect of Perineal Massage on the Frequency of Episiotomy and Perineal Tearing
A randomized controlled trial was conducted at the Department of Obstetrics and Gynaecology, Sheikh Zayed Hospital, Rahim Yar Khan, over 6 months following Institutional Review Board and College of Physicians and Surgeons…
- Trial name
- NCT07374497
- Testing
- Intrapartum perineal massage, Standard Intrapartum Care Group (Control)
- Where
- Pakistan
- Volunteers
- 202 people
- Sponsor
- Sheikh Zayed Medical College
Perineal Tear, Perineal Laceration (Obstetric)
Comparison Between Rectal Suppository Acetaminophen and Diclofenac Sodium as Analgesia for Postpartum Perineal Tear
To assess the prevalence of pain score for perineum pain following childbirth followed by phase 2 study to assess the analgesic effectiveness of acetaminophen and diclofenac rectal suppository in postpartum perineum pain…
- Trial name
- SuPPerP (NCT03041779)
- Testing
- Diclofenac Sodium 50Mg Suppository, Paracetamol 500Mg Suppository
- Volunteers
- 909 people
- Sponsor
- Clinical Research Centre, Malaysia
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
Hemorrhage of Cesarean Section and/or Perineal Wound
Efficacy of Tranexamic Acid in Reducing Blood Loss During and After Caesarean Section
The aim of this study is to evaluate the efficacy of tranexamic acid in reducing blood loss during and after elective C.S. The Research Question Is Tranexamic acid effective in reducing blood loss during and after elective…
- Trial name
- NCT02350179
- Testing
- Tranexamic Acid, Glucose
- Where
- Egypt
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
Perineal Wound Infection
Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term
The purpose of this study is to determine amoxicillin is effective in the prevention of wound infection in normal labor.
- Trial name
- NCT02131818
- Testing
- Amoxicillin
- Where
- Thailand
- Volunteers
- 5 people
- Sponsor
- Mahidol University
Adenocarcinoma (NOS)
Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation
Abdomino-perineal resection is a surgical procedure involving the removal of the rectum and anus via abdominal and perineal approaches. During this procedure, a terminal colostomy is created and the perineum is closed.
- Trial name
- AAPICO (NCT07489820)
- Testing
- Direct perineal skin suturing with negative pressure wound therapy (PICO 7®), Direct perineal skin suture
- Where
- 5 sites in France
- Volunteers
- 100 people
- Sponsor
- Centre Hospitalier Departemental Vendee
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
Episiotomy; Complications, Laceration
Comparison Low-Level Laser Therapy With Cryotherapy in Parturients With Laceration and/or Episiotomy on Pain Reduction
The changes that occur during pregnancy can lead to symptoms and complaints for women. Vaginal delivery has several benefits for both the mother and baby; however, during labor, some injuries may occur, such as lacerations and…
- Trial name
- CL (NCT06370910)
- Testing
- Low-Level Laser Therapy
- Where
- Brazil
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Federal University of Rio Grande do Sul
Prevention
THE EFFECT OF PERİNEUM MASSAGE WİTH OLİVE OİL ON PERİNEUM INTEGRİTY AND DURATİON OF SECOND PERİOD OF DELİVERY
Aims and objectives:This experimental study was conducted to determine the effect of perineum massage with olive oil performed in the second period of the delivery on travay duration, episiotomy requirement and perineum tears in…
- Trial name
- NCT04157777
- Testing
- Perineum massage with olive oil
- Volunteers
- 700 people
- Sponsor
- TC Erciyes University
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 Tear, Episiotomy Wound
Continuous Versus Discontinuous Suture in the Perineals Lesions
The hypothesis: Women who have a continuous suture have better health outcomes Two types of sutures were placed in the perineal lesion, using different techniques.
- Trial name
- NCT03825211
- Testing
- Continuous suture in the perineals lesions, Discontinuous suture in the perineals lesions
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- University of Jaén
Pain, Postpartum Depression
Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries
Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term.
- Trial name
- NCT03470675
- Testing
- Epidural saline + IV saline, Epidural morphine 3 mg + IV saline, Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Northwestern University
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