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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03780530
Other study ID # Ain shams maternity U
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date January 1, 2019
Est. completion date December 1, 2019

Study information

Verified date December 2018
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
subcuticular suturing
Those undergoing Subcuticular suturing of perineal skin using 910 polyglactin vicryl No 2/0 (EGYCRYL®).
Surgical glue
Those undergoing perineal skin closure using adhesive glue n-butyl-2-cyanoacrylate (Histoacryl®).
adhesive steri-strip tape
Those undergoing closure of perineal skin via Adhesive surgical water-resistant tape application. (3M® Transporeā„¢ Surgical Tapes).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

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
See also
  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