Episiotomy Clinical Trial
Official title:
Comparison of Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair
Verified date | December 2018 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
this study aims to assess the efficacy and the safety of various cosmetic techniques (subcuticular, surgical glue, adhesive tapes) for perineal skin closure during mediolateral episiotomy repair
Status | Not yet recruiting |
Enrollment | 207 |
Est. completion date | December 1, 2019 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Women aged above 18 yrs. - Primiparous. - Undergoing spontaneous vaginal delivery of a single full-term fetus. - Vertex presentation. - Having mediolateral episiotomy. Exclusion Criteria: - Body mass index = 35 kg/m2 - Complicated delivery by any tears other than episiotomy or postpartum hemorrhage. - Any risk factor causing increased stretch of the perineum; Operative vaginal delivery, fetal macrosomia. - The use of epidural anesthesia. - Previous perineal surgeries, local infection or lesions. - Any medical condition that can cause excessive bleeding or impair wound healing; (cardiovascular disease, diabetes, anemia, coagulopathy, collagen disease or Immunosuppression). - Contraindication or Hypersensitivity to any of materials used in the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short -term postpartum pain | Post-operative perineal pain will be evaluated at 6 hrs after the procedure using visual analogue scale patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain | six hours postpartum | |
Primary | Short -term postpartum pain | Post-operative perineal pain will be evaluated at 10 days after the procedure using visual analogue scale patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain | 10 days postnatal |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02762357 -
PMCF-study Using Novosyn® Quick Suture Material for Perineal Repair After Episiotomy
|
||
Completed |
NCT00070720 -
Improving Perinatal Care in Latin America
|
Phase 4 | |
Completed |
NCT03084549 -
Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain
|
Phase 3 | |
Not yet recruiting |
NCT06415877 -
The Effect of the Modified Simulation Model on Self-Efficacy, Anxiety, and Academic Motivation in Episiotomy Training
|
N/A | |
Recruiting |
NCT05345600 -
MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery
|
N/A | |
Active, not recruiting |
NCT02615236 -
Prospective Evaluation of Perineal Ultrasound in Thr Delivery Room to Improve the Diagnosis of OASIS
|
N/A | |
Recruiting |
NCT02847936 -
Efficacy of Triclosan-coated Sutures in the Episiotomy
|
Phase 4 | |
Withdrawn |
NCT02796547 -
Effect of Levobupivacaine Infiltration on the Post Partum Perineal Pain in Episiotomy, in Primiparous Women After Instrumental Delivery
|
Phase 2 | |
Completed |
NCT02905695 -
Post-partum Perineal Pain - Chirocaine®
|
Phase 4 | |
Not yet recruiting |
NCT05905263 -
The Effect of Virtual Reality Application on Student Satisfaction, Self-Confidence, and Anxiety Levels
|
N/A | |
Completed |
NCT02911779 -
The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor
|
N/A | |
Completed |
NCT02608671 -
Adhesive Tape in Episiotomy Repair
|
Phase 4 | |
Completed |
NCT05776849 -
Flipped Classroom in Episiotomy Education
|
N/A | |
Completed |
NCT00265421 -
Study of Different Suturing Techniques for Perineal Repair After Delivery
|
N/A | |
Completed |
NCT05486624 -
The Effect of Reiki Application on Episiotomy and Perineal Pain
|
N/A | |
Completed |
NCT00196508 -
A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth
|
Phase 3 |