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

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03611452
• Collaborator: (none)
• Enrollment: 138
• Arms: 3
• Anticipated Duration (Months): 7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Aug 1, 2018
• Anticipated Primary Completion Date: Jan 1, 2019
• Anticipated Study Completion Date: Mar 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the mean score of Perineal pain during vaginal suturing [10 minutes]

   assessment through visual analog scale score from 0 - 10 at every step of repair

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03611452
• Other Study ID Numbers: SCIE
• First Posted: Aug 2, 2018
• Last Update Posted: Aug 2, 2018
• Last Verified: Aug 1, 2018

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

Study Results

No Results Posted as of Aug 2, 2018