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

NCT00777270 | Completed DMC

• 1 other identifier: FIS-PI051023
• Study Type: interventional
• Target: 445
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

episiotomy; perineal lesion; vaginal trauma

Outcome Measures

Primary Outcomes (1)

• Pain at that moment ("pain now")

  the second and the tenth day and at the three months.

Secondary Outcomes (1)

• 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 Arms (2)

1 continuous

EXPERIMENTAL

continuous suture technique with continuous non-locking suture in the vagina, perineum and subcutaneous tissue.

Procedure: repair of episiotomy or second degree tears

2 interrupted

EXPERIMENTAL

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

Interventions

repair of episiotomy or second degree tears PROCEDURE

continuous suture technique with continuous non-locking suture in the vagina, perineum and subcutaneous tissue.

Also known as: (Vicryl Rapid; Ethicon)

1 continuous

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• instrumentation
• produce injury in the anal sphincter or in the rectum.
• serious congenital malformations.

Sponsors & Collaborators

• Hospital Universitario Principe de Asturias: lead

Study Sites (1)

Fundación Hospital Príncipe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

Location

Related Publications (2)

• 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.

  PMID: 12103284 RESULT

• 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.

  PMID: 2406391 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pedro Valenzuela, MD

  Hospital Prínicpe de Asturias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: September 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: October 1, 2007
• Last Updated: October 22, 2008

Record last verified: 2008-10

Locations

ES (1)