Clinical trials: Perineum; Rupture
Episiotomy; Complications, Scar Tissue
Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue A Pilot RCT
The goal of this Pilot Randomized Control Trial (RCT) is to determine if a larger RCT evaluating the effect of self-scar tissue massage of episiotomy and/or vagina/perineal tear scar tissue on pelvic health outcomes is feasible.
- Conditions
- Episiotomy; Complications, Scar Tissue, Perineal Tear, Vaginal Tear Resulting From Childbirth
- Trial name
- EPIS (NCT05908292)
- Testing
- Pelvic Floor Scar Tissue Self-Scar Massage
- Where
- Canada
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Calgary
Perineal Pain, Birth Satisfaction
The Effect of Birth Ball and Perineal Massage on Perineal Pain, Perineal Trauma and Birth Satisfaction
One of the important causes of perineal trauma is perineal tension. By reducing this tension, perineal trauma can be prevented. Perineal trauma is a birth complication that can be prevented with midwifery approaches.
- Conditions
- Perineal Pain, Birth Satisfaction, Perineal Laceration, Tear, or Rupture During Delivery
- Trial name
- NCT06935643
- Testing
- Birth Ball, Perineal Massage, Control Group
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
Delivery Problem, Childrearing
Perineal Massage Performed During the Labour
In this study, perineal massage was applied to primiparous women who did not give birth before, as a quasi-experimental control group to determine the effects of massage on birth comfort, perineal trauma and perineal pain.
- Conditions
- Delivery Problem, Childrearing, Satisfaction, Patient, Perineum; Injury
- Trial name
- NCT05962918
- Testing
- Perinal massage
- Where
- Turkey (Türkiye)
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- Munzur University
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 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
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 Tear, Perineal Tear
Application of a Perineal Protection Device in Vacuum-assisted Births
Visible birth tears are common in vaginal births, especially in vacuum-assisted births. One aim of obstetrical work is to minimize such injuries by an adequate birth management , for example with a proper perineal support.
- Trial name
- NCT04370340
- Testing
- BabySlide
- Where
- Switzerland
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- University of Zurich
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
Obstetric Anal Sphincter Injury, Severe Perineal Trauma
CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence
The aim of this study is to ascertain which pathways currently exist in relation to the follow up of patients with obstetric anal sphincter injury related incontinence.
- Conditions
- Obstetric Anal Sphincter Injury, Severe Perineal Trauma, Grade 3 Perineal Tear, Grade 4 Perineal Tear
- Trial name
- CArE for OAsI (NCT06143072)
- Where
- United Kingdom
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- London North West Healthcare NHS Trust
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
Vaginal Discharge, Perineum; Rupture
Efficacy and Safety of the Application of Local Anaesthetic in Spray to Repair of 1st- 2nd Perineal Lacerations
Randomized controlled trial aimed at evaluating the efficacy and safety of the use of a local anesthetic spray, commonly used in clinical practice as off-label, during the suturing of perineal lacerations in post-partum…
- Conditions
- Vaginal Discharge, Perineum; Rupture, Analgesia
- Trial name
- LISPRAY (NCT05201313)
- Testing
- Lidocaine Hydrochloride, Mepivacaine Injection
- Where
- Italy
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
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
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
Perineal Tear
Descriptive Evaluation of Expulsive Efforts During Pregnancy in Term Nulliparous Women by Measurement of Intra Bladder Pressure: Pilot Observational Study.
Severe complications of childbirth are common. Many factors have been studied to assess their imputability in the occurrence of perineal tears.
- Trial name
- ACCOUPIV (NCT04544488)
- Testing
- Recording of expulsive efforts by connection of a pressure sensor to the women's bladder probe
- Where
- France
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Poitiers University Hospital
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
Obstetric Perineal Rupture
Diagnosing Perineal Tears, Does Different Assessment Methods Affect the Midwife's Clinical Judgement of Perineal Tears?
This study aims to compare different midwife practitioners assessments of perineal tears.
- Trial name
- NCT01278979
- Testing
- Objective measurements of perineal tears with "Peri-Rule", Visual and digital assessment
- Where
- Norway
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Ostfold Hospital Trust
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, 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
Perineal Tear
The Effect of Neuraxial Morphine (Duramorph) on Pain Control
With the rise of the opioid epidemic, it is important for physicians to be more mindful of the amount of narcotic prescriptions that are being written every day.
- Trial name
- NCT03926559
- Testing
- Morphine.
- Where
- United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Augusta 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