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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: repair of episiotomy or second degree tears; Procedure: repair of episiotomy or second degree tears

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: Interventional
• Enrollment (Actual): 445
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcalá de Henares, Madrid, Spain, 28805
      • Fundación Hospital Príncipe de Asturias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: (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 Names: (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; continuous suture technique with continuous non-locking suture in the vagina, perineum and subcutaneous tissue.; Other Names: (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 Names: (Vicryl Rapid; Ethicon).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain at that moment ("pain now")	the second and the tenth day and at the three months.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Hospital Universitario Principe de Asturias
• Investigators: Principal Investigator: Pedro Valenzuela, MD, Hospital Prínicpe de Asturias

Publications and helpful links

General Publications

• Kettle C, Hills RK, Jones P, Darby L, Gray R, Johanson R. Continuous versus interrupted perineal repair with standard or rapidly absorbed sutures after spontaneous vaginal birth: a randomised controlled trial. Lancet. 2002 Jun 29;359(9325):2217-23. doi: 10.1016/S0140-6736(02)09312-1.
• Fleming N. Can the suturing method make a difference in postpartum perineal pain? J Nurse Midwifery. 1990 Jan-Feb;35(1):19-25. doi: 10.1016/0091-2182(90)90053-8.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (ACTUAL): July 1, 2007
• Study Completion (ACTUAL): October 1, 2007

Study Registration Dates

• First Submitted: October 21, 2008
• First Submitted That Met QC Criteria: October 21, 2008
• First Posted (ESTIMATE): October 22, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 22, 2008
• Last Update Submitted That Met QC Criteria: October 21, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: episiotomy; perineal lesion; vaginal trauma
• Other Study ID Numbers: FIS-PI051023