Clinical trials: Perineal Laceration
Pain, Patient Satisfaction
Patient-controlled Sedation During Repair of Obstetric Perineal Lacerations
The PROP(ofol)-study (EU CT number: 2022-502292-39-00, protocol number: ) is a clinical trial phase IV single centre prospective randomized controlled trial with parallel groups.
- Trial name
- NCT06044103
- Testing
- PDB + PCS
- Where
- Sweden
- Volunteers
- 80 people
- Sponsor
- Marie Blomberg
Second Stage of Labor
Searching for the Perfect Oil to Protect the Perineum: A Randomized-Controlled, Double-Blind Trial
In this study we intend to randomly assign each parturient one of two commonly used oils to be applied during the second stage of labor, one of them containing vitamin E.
- Trial name
- NCT00662974
- Testing
- perineal massage with Wheat Germ Oil during the second stage of labor, perineal massage with almond oil during the second stage of labor
- Where
- Israel
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Soroka University Medical Center
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 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
Perineum; Injury, Episiotomy Wound
Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration And Episiotomy
Virtual Reality will be used to decrease anxiety and pain during suturing of episiotomy and perineal lacerations
- Conditions
- Perineum; Injury, Episiotomy Wound, Anxiety
- Trial name
- NCT04693013
- Testing
- Virtual Reality for Anxiety Reduction
- Where
- Israel
- Volunteers
- 84 people
- Sponsor
- Ziv Hospital
Birth Injuries, Lacerations
Acupuncture for Pain Relief During Perineal Repair After Childbirth
Midwives and obstetricians are currently using acupuncture for several health problems during pregnancy and childbirth. The investigators wish to determine whether acupuncture can be used as pain relief during the repair of…
- Conditions
- Birth Injuries, Lacerations, Pain
- Trial name
- NCT00328796
- Testing
- acupuncture in 6 specific points, lidocaine 10mg/ml
- Where
- Denmark
- Volunteers
- 207 people
- Sponsor
- Sonderborg Hospital
Dyspareunia, Urinary Incontinence
The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function.
Perineal injury is the most common maternal obstetric complication associated with vaginal delivery (1). It is estimated that perineal lacerations of first and second degree occur in 38% of spontaneous vaginal deliveries in…
- Conditions
- Dyspareunia, Urinary Incontinence, Perineal Tear, Perineal Injury
- Trial name
- NCT05282160
- Testing
- Epino
- Where
- Brazil
- Volunteers
- 70 people
- Sponsor
- Universidade Estadual de Londrina
Perineal Tear, Episiotomy Wound
Selective Use of Episiotomy: the Impact on Perineal Trauma.
Vaginal delivery is commonly accompanied by trauma of the genital tract. Perineal trauma is classified into four degrees based on anatomic structures involved and severity of lacerations according to the American College of…
- Conditions
- Perineal Tear, Episiotomy Wound, Delivery; Injury, Maternal
- Trial name
- SEPT-1 (NCT03559816)
- Testing
- Classification of perineal tears based on new classification, Selective use of Episiotomy
- Where
- Italy
- Volunteers
- 10,000 people
- Sponsor
- Universita di Verona
Delivery; Trauma, Pelvic Floor; Perineal Rupture, Obstetric
Perineal Preparation for Pregnant Ladies.
Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage.
- Conditions
- Delivery; Trauma, Pelvic Floor; Perineal Rupture, Obstetric, Pelvic Floor Muscle Weakness
- Trial name
- NCT03287258
- Testing
- 3 program, one program
- Where
- Egypt
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Kasr El Aini Hospital
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
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
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
Perineal Tear
Lidocaine, Povidone Iodine, and Honey Application on Second-degree Perineal Tear Healing
This clinical trial aims to compare the effectiveness of the continuous application of lidocaine cream, honey, and povidone-iodine cream in second-degree perineal tear healing.
- Trial name
- NCT05946005
- Testing
- honey, lidocaine, povidone-iodine
- Where
- Indonesia
- Volunteers
- 200 people
- Sponsor
- Hasanuddin University
Vaginal Laceration During Delivery
Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.
The goal of this observational study is to learn whether different classification systems for second-degree perineal tears can predict postpartum complications in women undergoing spontaneous vaginal childbirth.
- Trial name
- LAC-VAG-2025 (NCT07124676)
- Where
- Italy
- Volunteers
- 482 people
- Sponsor
- University of Campania Luigi Vanvitelli
Obstetric; Injury Pelvic Floor
Perineal Massage During Labor for the Prevention of Perineal Trauma
The purpose of this study is to evaluate whether perineal massage during labor can help prevent perineal trauma, such as lacerations or episiotomies.
- Trial name
- NCT07099690
- Testing
- Perineal massage
- Where
- Brazil
- Volunteers
- 466 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
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; Tear
Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears
There is a controversy regarding whether warm compresses influence the rate of intact perineum after a vaginal delivery. According to a meta-analysis published in 2019 that included 7 randomized prospective trials, approximately…
- Trial name
- NCT05851170
- Testing
- The use of warm compresses and almond oil on the perineum during second stage, Use of almond oil use (routine care) during second stage
- Where
- Israel
- Volunteers
- 412 people, healthy volunteers welcome
- Sponsor
- Western Galilee Hospital-Nahariya
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
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