Clinical trials: Perineal Tear
Secons Stage of Labor
The Effect Of Kristeller Maneuver On Maternal And Neonatal Outcome
The use of fundal pressure in management of the second stage of labor is controversial. The aim of this study is both to evaluate the effectiveness of fundal pressure in shortening the second stage of labor and to examine the…
- Trial name
- NCT01939873
- Testing
- KRISTELLER
- Where
- Turkey (Türkiye)
- Volunteers
- 285 people, healthy volunteers welcome
- Sponsor
- Kayseri Education and Research Hospital
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
Tear, Pelvic Organ, Obstetric Trauma
A Pilot Study To Evaluate The Preliminary Safety And Feasibility Of The Materna Medical Device
The Materna device aims to prevent pelvic tissue damage by preventing overstretching of pelvic floor muscle fibers during delivery.
- Trial name
- NCT02332759
- Testing
- Materna Medical
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Vaginal Delivery, Perineal Tear Resulting From Childbirth
Comparison of Finnish and Viennese Techniques for Perineal Protection in Women During the Second Stage of Labor
The goal of this clinical trial is to find out which method of protecting the perineum during childbirth works better in reducing tears in first-time mothers.
- Trial name
- NCT07537842
- Testing
- Finnish Manual Perineal Protection Technique, Viennese Manual Perineal Protection
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Nishtar Medical 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
Perineal Tear
Hands on vs Hands Off for Perineal Laceration
Perineal trauma at the time of vaginal delivery is common, and when the anal sphincter is included, these injuries can be associated with additional morbidity including incontinence, pelvic pain and sexual dysfunction.
- Trial name
- NCT04860102
- Testing
- hands on
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Federico II University
Anal Sphincter Injury
The Effect of Episiotomy on Maternal and Fetal Outcomes (EPITRIAL)
This study is aimed to evaluate the influence of episiotomy on various maternal and neonatal outcomes. Half of the participants will undergo selective episiotomy (according to routine delivery management at the particular…
- Trial name
- NCT02356237
- Testing
- No episiotomy
- Where
- Israel
- Volunteers
- 676 people
- Sponsor
- Lena Sagi-Dain
Neuralgia, Perineal
Promoting Optimal Healing After Laceration Repair Study
The goal of this research is to investigate three different methods of perineal skin closure during second-degree perineal wound repair and determine which method is associated with the least amount of patient pain.
- Trial name
- PALS (NCT02055794)
- Testing
- Suturing of the perineal skin, Closing perineal skin with surgical glue, No suturing of the perineal skin
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Perineal Tear Resulting From Childbirth
Perineal Massage and Warm Compresses - RCT for Reduce Perineal Trauma During Labor
The aim of this study is to evaluate the effect of a combined perineal massage and warm compresses intervention on the perineum integrity during second stage of labor.
- Trial name
- PeMWaC (NCT05854888)
- Testing
- Perineal Massage and Warm Compresses (PeMWaC), Control Group (Hands-on)
- Where
- Portugal
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Universidade do Porto
Pelvic Floor Disorders, Pelvic Floor; Perineal Rupture, Obstetric
The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury.
The goal of this pilot randomized pilot controlled trial (RTC)is to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator injury that is intended to be used in a larger…
- Conditions
- Pelvic Floor Disorders, Pelvic Floor; Perineal Rupture, Obstetric, Physiotherapy
- Trial name
- NCT05617092
- Testing
- Physiotherapy treatment
- Where
- Sweden
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Vastra Gotaland Region
Post-partum Perineal Pain, Episiotomy
Post-partum Perineal Pain - Chirocaine®
The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree tear.
- Conditions
- Post-partum Perineal Pain, Episiotomy, Vaginal Tear
- Trial name
- EPISIO (NCT02905695)
- Testing
- Chirocaine
- Where
- France
- Volunteers
- 110 people
- Sponsor
- Hopital Foch
Vaginal Laceration During Delivery
The PAIN (Pelvic Area Injection for Numbness) Study
Postpartum pain can interfere with patient's ability to care for themselves, and their newborn, and untreated pain is associated with risk of greater opioid use, postpartum depression, and development of persistent pain.
- Trial name
- PAIN (NCT05972681)
- Testing
- Bupivacaine, Epinephrine
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
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
Dyspareunia, Pelvic Pain
Electrolysis Technique vs Manual Therapy in Pelvic Pain
Pelvic floor muscle physical therapy is recommended in clinical guidelines for women dyspareunia and pelvic pain. This study compare pelvic floor manual therapy and intratissue percutaneous electrolysis (EPI) technique in the…
- Conditions
- Dyspareunia, Pelvic Pain, Pelvic Floor Disorders, Musculoskeletal Pain
- Trial name
- NCT03163160
- Testing
- Pelvic floor manual therapy group, Pelvic floor electrolysis group
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Quirón Madrid University Hospital
Perineum; Rupture, Perineum; Tear
In Vivo Evaluation of Perineal Mechanical Properties During Childbirth
The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.
- Conditions
- Perineum; Rupture, Perineum; Tear, Perineal Tear
- Trial name
- MecaPer (NCT05556304)
- Testing
- assessment in the 8th month of pregnancy and during delivery
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Parturition, Delivery, Obstetric
Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth
During childbirth, the recommendations have evolved to a restriction of episiotomy. This reduction results in an increase of superficial vaginal and perineal tears.
- Trial name
- ImSOLENCE (NCT02870712)
- Testing
- Suture of perineum, hemostatis by digital compression
- Where
- France
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Improving Quality of Life
Pain Relief During Repair of Postpartum Perineal Tears
The aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during repair of postpartum perineal tears.
- Trial name
- LPPT (NCT02883179)
- Testing
- lidocaine injection, lidocaine-prilocaine cream
- Where
- Egypt
- Volunteers
- 144 people
- Sponsor
- Assiut University
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
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 Tear and Episiotomy
The Effect of Mucogyne® Gel on Wound Healing
The aim of this post-market clinical follow up study is to confirm the efficacy and safety of topical application of Mucogyne® gel in the process of wound healing, when used in accordance with its approved labeling, in the…
- Trial name
- ARTHEMIS (NCT05888194)
- Testing
- Mucogyne® gel
- Where
- 3 sites in France
- Volunteers
- 118 people
- Sponsor
- Biocodex