Clinical trials: Lacerations Perineal
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
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 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
Dyspareunia
Effectiveness of Radiofrequency Combined With Ultrasound for the Treatment of Postpartum Dyspareunia
The objective of this community-based, non-randomized, quasi-experimental study is to assess the effectiveness of BTL EXILIS technology-based on combined radiofrequency and ultrasound-in women of childbearing age from an…
- Trial name
- NCT07504991
- Testing
- Combining radiofrequency and ultrasound. BTL Exilis
- Where
- Spain
- Volunteers
- 34 people
- Sponsor
- Institut Investigacio Sanitaria Pere Virgili
Grade 1 Perineal Tears
Biologic Glue for First Degree Perineal Tears
The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for first degree perineal tears repair
- Trial name
- NCT00746707
- Testing
- 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate, 3. traditional suturing with vicryl rapid 2X0
- Where
- Israel
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization
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
Dyspareunia, Perineal Tear
Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair
To evaluate the rates of dyspareunia with rapidly absorbing polyglactin 910 compared to poliglecaprone 25 using a validated sexual function questionnaire.
- Conditions
- Dyspareunia, Perineal Tear, Sutured Laceration
- Trial name
- NCT03184077
- Testing
- Laceration Repair with Polyglactin 910, Laceration Repair with poliglecaprone 25
- Where
- United States
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Virginia Commonwealth University
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
Parturition
Perineal Echography in the Delivery Room for the Detection of Anal Lesions
The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive…
- Trial name
- OASIS 1 (NCT01320995)
- Testing
- Perineal ultrasound
- Where
- 2 sites in France
- Volunteers
- 111 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
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
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
Labor Complication
Comparison of Routine Versus Restrictive Episiotomy in Primigravida Women at Term.
The ongoing debate over routine versus selective episiotomy in primiparous term women underscores the necessity for updated local data.
- Trial name
- NCT07796685
- Testing
- Routine Episiotomy, Restrictive Episiotomy
- Where
- Pakistan
- Volunteers
- 466 people
- Sponsor
- Muhammad Aamir Latif
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
Cold Compress
Effect of Perineal Massage Combined With Cold Compress in the Second Stage on the Delivery Outcome of Primipara
Objective: The aim of this study was to investigate the effect of perineal massage and cold compress in second stage on the delivery outcome of primipara.
- Trial name
- NCT05350670
- Testing
- Perineal massage and cold compress
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Pelvic Floor Disorders, Urinary Incontinence
Effects of Epi-no Device on Pelvic Floor Dysfunctions
Perineal injury is the most common maternal obstetric complication associated with vaginal delivery. Perineal traumas are associated with maternal morbidity, including pain, urinary and fecal incontinence, genital prolapses…
- Conditions
- Pelvic Floor Disorders, Urinary Incontinence, Dyspareunia, Lacerations Perineal
- Trial name
- NCT04955418
- Testing
- Epi-No®, Evaluation
- Where
- Brazil
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Universidade Estadual de Londrina
Perineal Lacerations
A Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations
The investigators hypothesize that the rate of perineal lacerations in nulliparous women will be reduced by a simple change in common obstetrical delivery practice, i.e., bed delivery versus conventional delivery in obstetrical…
- Trial name
- NCT00895973
- Testing
- Stirrups delivery vs bed delivery
- Where
- United States
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Perineal Lacerations, Episiotomy
Study of Different Suturing Techniques for Perineal Repair After Delivery
We wish to determine wich of two standardized suturing techniques is the best for perineal repair if a perineal laceration or an episiotomy is present after vaginal birth.
- Trial name
- NCT00265421
- Testing
- Suture technique for perineal repair after delivery
- Where
- Denmark
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Urinary Incontinence, Pelvic Organ Prolapse
Promoting Effective Recovery From Labor Urinary Incontinence (PERL)
The purpose of this study is to determine whether pushing during labor that is controlled by the woman results in less birth-related injury and less postpartum urinary incontinence (UI).
- Conditions
- Urinary Incontinence, Pelvic Organ Prolapse, Perinatal Laceration, Second Stage Labor
- Trial name
- PERL (NCT00506116)
- Testing
- Videotape, routine care, PME instruction, PME practice and record keeping (in diaries), Non-directed or directed,spontaneous or sustained pushing
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of Michigan
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