Status:

UNKNOWN

Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair

Lead Sponsor:

Ain Shams University

Conditions:

Episiotomy

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

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

Eligibility Criteria

Inclusion

  • Women aged above 18 yrs.
  • Primiparous.
  • Undergoing spontaneous vaginal delivery of a single full-term fetus.
  • Vertex presentation.
  • Having mediolateral episiotomy.

Exclusion

  • 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.

Key Trial Info

Start Date :

January 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2019

Estimated Enrollment :

207 Patients enrolled

Trial Details

Trial ID

NCT03780530

Start Date

January 1 2019

End Date

December 1 2019

Last Update

December 20 2018

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