Clinical trials: Obstetric Perineal Rupture
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
Obstetric Trauma, Infections
Oral Antibiotics After Obstetric Perineal Tear
The purpose of this study is to investigate if 3 dose of oral antibiotics administrated the first day after a vaginal delivery with a second degree obstetric tear will decrease the risk of infection and/or wound dehiscence…
- Conditions
- Obstetric Trauma, Infections, Wound Dehiscence
- Trial name
- REPAIR (NCT05830162)
- Testing
- Bioclavid (Amoxicillin and Clavulanic acid)
- Where
- Denmark
- Volunteers
- 442 people
- Sponsor
- Hanna Jangö
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
Perineal Trauma, Hands-on Technique
Hands-on vs Hands-off Techniques in Perineal Protection
Perineal tears are frequent during vaginal delivery. This study evaluates the impact of hands-on versus hands-off techniques on perineal and neonatal outcomes to determine the most effective protective strategy.
- Conditions
- Perineal Trauma, Hands-on Technique, Hands-of Technique, Manual Perineal Protection
- Trial name
- MPP (NCT07492940)
- Where
- Italy
- Volunteers
- 737 people
- Sponsor
- Azienda ULSS 8 Berica
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
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
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 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
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
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
Delivery, Obstetric
Verifying Post-delivery Anal Sphincter Integrity Using Perineal Ultrasound: Impact on Immediate Care
The main objective of this study is to compare post partum rates of anal sphincter rupture (that is to say the rate of sutures) diagnosed in women with ≥ 2nd degree vaginal tears between two groups: (1) women who are screened…
- Trial name
- OASIS 2 (NCT01905644)
- Testing
- Perineal ultrasound
- Where
- 3 sites in France
- Volunteers
- 276 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
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
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
Urinary Incontinence, Postpartum
Efficacy of Physiotherapy for Urinary Incontinence in Women With a Puborectalis Avulsion
Childbirth is a major risk factor for pelvic floor muscle (PFM) trauma. In one third of women, stretching of the PFM will result in an avulsion injury (i.e.
- Conditions
- Urinary Incontinence, Postpartum, Pelvic Floor; Perineal Rupture, Obstetric, Physiotherapy
- Trial name
- NCT03254355
- Testing
- Multimodal physiotherapy
- Where
- Canada
- Volunteers
- 126 people
- Sponsor
- Université de Sherbrooke
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.
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
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
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
Sphincter (Anal); Perineal Rupture, Obstetric
Digital Rectal Examination vs Machine Learning-assisted Electrical Impedance Spectroscopy for Obstetric Anal Sphincter Injuries' Detection: a Prospective Cohort Study in Primiparous Women Giving Vaginal Childbirth
The investigator will evaluate the detection rate for Obstetric Anal Sphincter Injuries (OASI) in primiparas having given vaginal childbirth, comparing the sensitivity of methods available in a labour ward setting for rapid…
- Trial name
- NCT07474012
- Testing
- Primiparous women who have completed vaginal delivery will be submitted to a digital rectal examination and an examination with machine learning-assisted electrical impedance spectroscopy
- Volunteers
- 110 people
- Sponsor
- IRCCS San Raffaele
Sphincter (Anal); Perineal Rupture, Obstetric
Development and Validation of a Logistic Regression Algorithm to Predict the Risk of Obstetric Anal Sphincter Injury.
An obstetric anal sphincter injury (OASI) occurs during the final stage of a vaginal delivery. This tissue laceration, even if adequately sutured, poses a substantial threat to bowel continence in women.1,2 In a recent…
- Trial name
- NCT05218837
- Testing
- Vaginal birth
- Where
- Sweden
- Volunteers
- 800,000 people
- Sponsor
- Maria Gyhagen