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Clinical Trials/NCT00777270
NCT00777270
Completed
Not Applicable

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

Hospital Universitario Principe de Asturias1 site in 1 country445 target enrollmentSeptember 2005
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Hospital Universitario Principe de Asturias
Enrollment
445
Locations
1
Primary Endpoint
Pain at that moment ("pain now")
Status
Completed
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2005
End Date
October 2007
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Pain at that moment ("pain now")

Time Frame: the second and the tenth day and at the three months.

Secondary Outcomes

  • 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.)

Study Sites (1)

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