Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair
Comparison of Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair
1 other identifier
interventional
207
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2019
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedDecember 20, 2018
December 1, 2018
9 months
December 16, 2018
December 18, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (3)
subcuticular suturing
ACTIVE COMPARATORsurgical glue
ACTIVE COMPARATORadhesive steri-strip tape
ACTIVE COMPARATORInterventions
Those undergoing Subcuticular suturing of perineal skin using 910 polyglactin vicryl No 2/0 (EGYCRYL®).
Those undergoing perineal skin closure using adhesive glue n-butyl-2-cyanoacrylate (Histoacryl®).
Those undergoing closure of perineal skin via Adhesive surgical water-resistant tape application. (3M® Transpore™ Surgical Tapes).
Eligibility Criteria
You may qualify if:
- Women aged above 18 yrs.
- Primiparous.
- Undergoing spontaneous vaginal delivery of a single full-term fetus.
- Vertex presentation.
- Having mediolateral episiotomy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 16, 2018
First Posted
December 19, 2018
Study Start
January 1, 2019
Primary Completion
October 1, 2019
Study Completion
December 1, 2019
Last Updated
December 20, 2018
Record last verified: 2018-12