Clinical trials: Vaginal Laceration During Delivery
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
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
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
Second Degree Perineal Tear During Delivery - Delivered, Episiotomy; Complications
Perineal Local Infiltration Study
The prevalence of birth canal lacerations is more than 70% of all deliveries in Canada. The repair of such lacerations is usually done using a pre-existing epidural analgesia.
- Conditions
- Second Degree Perineal Tear During Delivery - Delivered, Episiotomy; Complications, Anesthesia, Local
- Trial name
- PLIS (NCT03672500)
- Testing
- Bupivacaine 0.5%+Epinephrine 50mc
- Where
- Canada
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Sunnybrook Health Sciences Centre
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
Vaginal Delivery, Suture, Complication
Mostafa Maged Four-stitch Technique in Closure the Episiotomy During Vaginal Delivery
Most primigravida is confronted with episiotomy during childbirth to prevent the perineal and vaginal lacerations which could be performed at birth.
- Conditions
- Vaginal Delivery, Suture, Complication, Tear; Cervix, Hematoma
- Trial name
- NCT05247073
- Testing
- patients of controlled group with routine closure of episiotomy, The Mostafa Maged four-stitch technique fore closure of the episiotomy
- Volunteers
- 50 people
- Sponsor
- Fayoum University
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
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
Perineal Laceration, Tear, or Rupture During Delivery
Study on Fewer Tears (SOFT) - The Effect of Local Anesthesia on the Incidence of Perineal Tears in the First Vaginal Birth
The SOFT study investigates whether local anaesthesia during the second stage of labor decreases the incidence of perineal tears, including sphincter injuries, in women with their first vaginal birth (non-instrumental).
- Trial name
- SOFT (NCT07499752)
- Testing
- Perineal protection techniques
- Where
- Sweden
- Volunteers
- 1,350 people
- Sponsor
- Karolinska Institutet
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
Perineal Laceration, Tear, or Rupture During Delivery
TRESPASS Clinical Study
The purpose of this study is to assess the superiority of a standardized perineal massage in the decrease in vagino-perineal lacerations.
- Trial name
- NCT06443736
- Testing
- Standardized perineal massage, Primary prevention
- Where
- Italy
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
Perineal Tear, Perineum; Rupture
Vocalization for the Second Stage of Labor (VOCAL)
A randomized open-label trial will be conducted to evaluate the effect of vocalization as a perineal protection maneuver during the second period of labor.
- Trial name
- VOCAL (NCT03605615)
- Testing
- vocalization
- Where
- Brazil
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
Vaginal Laceration During Delivery
Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair
Many women experience severe anal sphincter lacerations during childbirth, which put them at risk for infection, improper healing, and accidental bowel leakage.
- Trial name
- ASPIRe (NCT04573504)
- Testing
- Augmentin/Flagyl or Augmentin/Clindamycin
- Where
- United States
- Volunteers
- 274 people
- Sponsor
- Northwestern University