Skip to main content
OpenTrials
Completed

NCT Number: NCT00777270

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fundación Hospital Príncipe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

repair of episiotomy or second degree tears

Procedure

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

Other names: (Vicryl Rapid; Ethicon)

Primary outcomes

  1. Pain at that moment ("pain now")

    Time frame: 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.

    Time frame: at the three months.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Principe de Asturias

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 22, 2008
Registry last updated
Oct 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.