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

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.
 
ClinicalTrials.gov Identifier: NCT00777270
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : October 22, 2008
Sponsor:
Information provided by:
Hospital Universitario Principe de Asturias

Tracking Information
First Submitted Date  ICMJE October 21, 2008
First Posted Date  ICMJE October 22, 2008
Last Update Posted Date October 22, 2008
Study Start Date  ICMJE September 2005
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
Pain at that moment ("pain now") [ Time Frame: the second and the tenth day and at the three months. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Versus Interrupted Sutures for Repair of Episiotomy or Second Degree Tears: a Randomised Controlled Trial
Official Title  ICMJE Continuous Versus Interrupted Sutures for Repair of Episiotomy or Second Degree Tears: a Randomised Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Experimental: 1 continuous
    continuous suture technique with continuous non-locking suture in the vagina, perineum and subcutaneous tissue.
    Interventions:
    • Procedure: repair of episiotomy or second degree tears
    • Procedure: repair of episiotomy or second degree tears
  • Experimental: 2 interrupted
    interrupted technique with continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture
    Intervention: Procedure: repair of episiotomy or second degree tears
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2008)
445
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777270
Other Study ID Numbers  ICMJE FIS-PI051023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pedro Valenzuela, Fundación Hospital Principe de Asturias
Study Sponsor  ICMJE Hospital Universitario Principe de Asturias
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pedro Valenzuela, MD Hospital Prínicpe de Asturias
PRS Account Hospital Universitario Principe de Asturias
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP