Continuous Versus Interrupted Sutures for Repair of Episiotomy or Second Degree Tears: a Randomised Controlled Trial

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: repair of episiotomy or second degree tears

• Registration Number: NCT00777270
• Lead Sponsor: Hospital Universitario Principe de Asturias

Brief Summary

The best technique for this repair would be that which requires least time in realisation, least consumption of material for the repair and that which produces less pain at short and long-term permitting the resumption of intercourse quicker and with less pain thereby requiring less necessity to take out the stitches and less frequency of re stitching. The investigators research is looking for a technique for repairing the perineum more advantageously.

Detailed Description

445 women who participated in the project had undergone normal deliveries with episiotomy or second-grade tearing of the perineum. One group was repaired with continuous non-locking suture in the vagina, perineum and subcutaneous tissue. The other group used continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture. The threads used for stitching were identical in both groups. The same questions were asked concerning the sensation of pain and the use of painkillers, the second and the tenth day and at the three months.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2007-07
• Study Completion: 2007-10
• Status Verified: 2008-10
• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Last Update Submitted: 2008-10-21
• Study First Posted: 2008-10-22
• Last Update Posted: 2008-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 445

Inclusion Criteria

• vaginal childbirth
• at least 37 weeks of gestation
• assistance by one of the 4 matrons who participated in the project
• have been subjected to an episiotomy or the appearance of tearing that affected skin and muscle
• The newborn child had to be alive, viable

Exclusion Criteria

• instrumentation
• produce injury in the anal sphincter or in the rectum.
• serious congenital malformations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 interrupted	repair of episiotomy or second degree tears	interrupted technique with continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture
1 continuous	repair of episiotomy or second degree tears	continuous suture technique with continuous non-locking suture in the vagina, perineum and subcutaneous tissue.

Primary Outcome Measures

Name	Time	Method
Pain at that moment ("pain now")	the second and the tenth day and at the three months.

Secondary Outcome Measures

Name	Time	Method
If sexual intercourse had been re initiated, how long after childbirth, if pain had been experienced the first time and if this continued.	at the three months.

Trial Locations

Locations (1)

Fundación Hospital Príncipe de Asturias; 🇪🇸 Alcalá de Henares, Madrid, Spain