Clinical trials: Perineum; Injury
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
Pregnancy Complications
Obstetric Perineal Trauma and Physiotherapy
The main objective is to investigate effects of perineal trauma at birth on women´s health and whether early physiotherapy improves pelvic floor strength.
- Trial name
- NCT02682212
- Testing
- Physiotherapy intervention
- Where
- Iceland
- Volunteers
- 84 people
- Sponsor
- Landspitali University Hospital
Complication of Surgical Procedure
TCOT Effectiveness in Preventing Wound Infections in Perineal Resections
In colorectal surgery, oxygen insufflation (which leads to higher oxygen concentration in the surgical site) has been shown to decrease infection rate.
- Trial name
- NCT02374294
- Testing
- Epiflo
- Sponsor
- Neogenix, LLC dba Ogenix
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
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
Prolonged Second Stage of Labor, Other Specified Trauma to Perineum and Vulva During Delivery
The Effect of Straining Techniques on Women and Newborn
Purpose: To examine the effects of straining techniques on the duration of labor, perineal trauma status and newborn apgar score. Method: This study is a randomized controlled trial.
- Conditions
- Prolonged Second Stage of Labor, Other Specified Trauma to Perineum and Vulva During Delivery, Newborn; Vitality
- Trial name
- NCT05578794
- Testing
- Straining types
- Where
- Turkey (Türkiye)
- Volunteers
- 354 people, healthy volunteers welcome
- Sponsor
- Cumhuriyet 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
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
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
Childbirth
A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth
This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device.
- Trial name
- NCT06698185
- Testing
- Materna Prep Device
- Where
- United States
- Sponsor
- Materna Medical
Pregnancy Related, Delivery; Injury, Maternal
Manual Physical Therapy During Pregnancy on Post Partum Perineal Trauma and Pain
The purpose of this study is to explore the impact of pelvic floor physical therapy during pregnancy on delivery and the impact on the woman's body and function.
- Conditions
- Pregnancy Related, Delivery; Injury, Maternal, Pelvic Floor Disorders
- Trial name
- NCT04660708
- Testing
- manual physical therapy
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Milwaukee
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
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
Perineum; Injury, Anal Incontinence
Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities
A randomized controlled trial was undertaken at Rajavithi Hospital, Bangkok, Thailand, encompassing 106 primigravidae within the period of December 2023 to June 2024.
- Conditions
- Perineum; Injury, Anal Incontinence, Urinary Incontinence
- Trial name
- NCT06162312
- Testing
- Antenatal perineal massage
- Where
- Thailand
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Department of Medical Services Ministry of Public Health of Thailand
Rectal Cancer, Abdominoperineal Resection
APEMESH- Preventing Perineal Complications After Abdominoperineal Resection
Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection.
- Conditions
- Rectal Cancer, Abdominoperineal Resection, Wound Heal
- Trial name
- NCT04334421
- Testing
- Composite mesh
- Where
- Finland
- Volunteers
- 30 people
- Sponsor
- Elisa Mäkäräinen
Birth Trauma
Video Analysis of Vaginal Deliveries
Video documentation of vaginal deliveries to evaluate the impact of the support of the perineum
- Trial name
- NCT02295904
- Where
- Switzerland
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Sphincter (Anal); Perineal Rupture, Obstetric, Perineal Tear
One Plus One Equals Two, Will That do?
A new clinical practice to reduce perineal trauma has been adopted by many maternity wards in Sweden. This practice involves collegial midwifery assistance during the second stage of labor and the birth of the baby.
- Conditions
- Sphincter (Anal); Perineal Rupture, Obstetric, Perineal Tear, Pelvic Floor Disorders, Experience, Life
- Trial name
- Oneplus (NCT03770962)
- Testing
- Two midwives
- Where
- 4 sites in Sweden
- Volunteers
- 3,058 people
- Sponsor
- Region Skane
Pregnancy
Effects of Antenatal Pelvic Floor Preparation Techniques for Childbirth
Perineal trauma during childbirth is an important etiological factor of various undesirable complications to women's health, with emphasis on pelvic floor dysfunction.
- Trial name
- EAPFPTC (NCT02582580)
- Testing
- Perineal massage, Vaginal Dilator, Pelvic floor muscles training
- Where
- Brazil
- Volunteers
- 63 people
- Sponsor
- Universidade Federal de Sao Carlos
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
Perineal Tear, Pain
The Application of Honey on Perineal Sutures
Evaluate the effect of honey on perineal tears or episiotomies pain associated or not with anterior vulvar tears after vaginal delivery.
- Conditions
- Perineal Tear, Pain, Burns
- Trial name
- NCT03670420
- Testing
- Medical honey
- Where
- Switzerland
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University Hospital, Geneva