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

Episiotomy Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03611452
• Other study ID #: SCIE
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2018
• Est. completion date: March 2019

Study information

• Verified date: August 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Episiotomy Wound

Intervention

Procedure:
• Episiotomy
repair of perineal muscles and skin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the mean score of Perineal pain during vaginal suturing	assessment through visual analog scale score from 0 - 10 at every step of repair	10 minutes