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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777270
• Other study ID #: FIS-PI051023
• Status: Completed
• Phase: N/A
• First received: October 21, 2008
• Last updated: October 21, 2008
• Start date: September 2005
• Est. completion date: October 2007

Study information

• Verified date: October 2008
• Source: Hospital Universitario Principe de Asturias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: October 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• repair of episiotomy or second degree tears
continuous suture technique with continuous non-locking suture in the vagina, perineum and subcutaneous tissue.
• 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

Locations

Country	Name	City	State
Spain	Fundación Hospital Príncipe de Asturias	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Principe de Asturias

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Fleming N. Can the suturing method make a difference in postpartum perineal pain? J Nurse Midwifery. 1990 Jan-Feb;35(1):19-25. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain at that moment ("pain now")		the second and the tenth day and at the three months.	No
Secondary	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.	No

External Links

•   . World Health Organization. Managing Complications in Pregnancy and Childbirth. Section 3-Procedures