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Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03611452
Recruitment Status : Unknown
Verified August 2018 by Ahmed Mohamed Abbas, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Brief Summary:

Millions of women worldwide undergo perineal suturing after childbirth and the type of repair may have an impact on pain and healing.

The skin as a barrier between the internal structures and the external environment is exceptionally susceptible to injury, either through accidental injury or planned surgical incision. Today, as surgery increases in complexity, and the heightened public awareness of scar cosmesis and skin healing need to be optimized to ensure the overall success of the surgical procedure


Condition or disease Intervention/treatment Phase
Episiotomy Wound Procedure: Episiotomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears : A Comparative Study
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Simple continuous
the sutures will be taken continuously by simple method
Procedure: Episiotomy
repair of perineal muscles and skin

Active Comparator: subcuticular
the sutures will be taken subcuticular
Procedure: Episiotomy
repair of perineal muscles and skin

Active Comparator: interrupted
the sutures will be taken interrupted method
Procedure: Episiotomy
repair of perineal muscles and skin




Primary Outcome Measures :
  1. the mean score of Perineal pain during vaginal suturing [ Time Frame: 10 minutes ]
    assessment through visual analog scale score from 0 - 10 at every step of repair



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Normal vaginal delivery.
  • At term (37 40 weeks ).
  • Live baby.
  • Vertex presentation

Exclusion Criteria:

  • Third and fourth degree perineal tear.
  • Instrumental vaginal delivery.
  • Previous perineal surgery.
  • Anaemia with hemoglobin level < 9 g/dl.
  • Diabetes mellitus.
  • Coagulation abnormalities.
  • Postpartum hemorrhage.
  • Delivery conducted outside Woman HealthHospital.
  • Breech delivery.
  • Body mass index >35 kg/m2.
  • Local infectious lesions.
  • Anal fissures or hemorrhoid.
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Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03611452    
Other Study ID Numbers: SCIE
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No