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

M

Madrid Health Service

Status

Completed

Conditions

Pain

Treatments

Procedure: repair of episiotomy or second degree tears

Study type

Interventional

Funder types

Other

Identifiers

NCT00777270
FIS-PI051023

Details and patient eligibility

About

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.

Full 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.

Enrollment

445 patients

Sex

Female

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

445 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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