Clinical trials: Perineum; Rupture
Dehiscence Wound, Secondary Perineal Tear
Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour
The goal of this observational study is to make us more aware of the short and long-term outcomes for women having an uncomplicated healing process after a rupture or birth cut in the perineum after giving birth in relation to a…
- Conditions
- Dehiscence Wound, Secondary Perineal Tear, Episiotomy; Dehiscence
- Trial name
- HEAL (NCT06026423)
- Testing
- Clinical examination and pictures, Questionnaire
- Where
- Denmark
- Volunteers
- 302 people, healthy volunteers welcome
- Sponsor
- Herlev 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
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
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
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
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
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
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
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
Pregnancy Complications, Infectious
Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs
This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.
- Trial name
- NCT00186082
- Where
- 2 sites in United States
- Volunteers
- 147 people
- Sponsor
- Stanford University
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
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
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
Perineum; Tear, Traumatic, Anal Tear
Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results
French multicentric retrospective cohort study including patients who underwent an ano-perineal trauma following a personal watercraft/jet-ski accident and that were treated in France from January 2017 to December 2023.
- Conditions
- Perineum; Tear, Traumatic, Anal Tear, Anal Incontinence
- Trial name
- TP-JET (NCT06368284)
- Testing
- Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Montpellier
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
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
Episiotomy, Perineal Tear
A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth
This is a randomized controlled trial and multi-centered study with a 2-arm design. The treatment group will receive topical skin adhesive for skin closure of their wound and the control will receive sutures.
- Trial name
- NCT00196508
- Testing
- High Viscosity DERMABOND
- Where
- 5 sites in United States
- Volunteers
- 118 people
- Sponsor
- Ethicon, Inc.
Grade 1 Perineal Tears
Biologic Glue for First Degree Perineal Tears
The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for first degree perineal tears repair
- Trial name
- NCT00746707
- Testing
- 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate, 3. traditional suturing with vicryl rapid 2X0
- Where
- Israel
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization
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
Vaginal Lesion
Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?
The main objective of this study is to assess whether the presence of abnormal vaginal flora (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of delivery.
- Trial name
- NCT01822782
- Testing
- Bacteriological analysis of vaginal sample
- Where
- France
- Volunteers
- 1,100 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes