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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00777270
First Posted: October 22, 2008
Last Update Posted: October 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Universitario Principe de Asturias
  Purpose
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.

Condition Intervention
Pain Procedure: repair of episiotomy or second degree tears

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Continuous Versus Interrupted Sutures for Repair of Episiotomy or Second Degree Tears: a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Principe de Asturias:

Primary Outcome Measures:
  • Pain at that moment ("pain now") [ Time Frame: the second and the tenth day and at the three months. ]

Secondary Outcome Measures:
  • If sexual intercourse had been re initiated, how long after childbirth, if pain had been experienced the first time and if this continued. [ Time Frame: at the three months. ]

Enrollment: 445
Study Start Date: September 2005
Study Completion Date: October 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 continuous
continuous suture technique with continuous non-locking suture in the vagina, perineum and subcutaneous tissue.
Procedure: repair of episiotomy or second degree tears
continuous suture technique with continuous non-locking suture in the vagina, perineum and subcutaneous tissue.
Other Name: (Vicryl Rapid; Ethicon)
Procedure: 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
Other Name: (Vicryl Rapid; Ethicon).
Experimental: 2 interrupted
interrupted technique with continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture
Procedure: 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
Other Name: (Vicryl Rapid; Ethicon).

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.
  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777270


Locations
Spain
Fundación Hospital Príncipe de Asturias
Alcalá de Henares, Madrid, Spain, 28805
Sponsors and Collaborators
Hospital Universitario Principe de Asturias
Investigators
Principal Investigator: Pedro Valenzuela, MD Hospital Prínicpe de Asturias
  More Information

Additional Information:
Publications:
Responsible Party: Pedro Valenzuela, Fundación Hospital Principe de Asturias
ClinicalTrials.gov Identifier: NCT00777270     History of Changes
Other Study ID Numbers: FIS-PI051023
First Submitted: October 21, 2008
First Posted: October 22, 2008
Last Update Posted: October 22, 2008
Last Verified: October 2008

Keywords provided by Hospital Universitario Principe de Asturias:
episiotomy
perineal lesion
vaginal trauma