Clinical trial NCT00777270: Continuous Versus Interrupted Sutures for Repair of Episiotomy or Second Degree Tears: a Randomised Controlled Trial
Official title: Continuous Versus Interrupted Sutures for Repair of Episiotomy or Second Degree Tears: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: episiotomy
perineal lesion
vaginal trauma
Lead sponsor: Hospital Universitario Principe de Asturias
Sponsor class: OTHER
First posted: 2008-10-22
Enrollment: 445
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain at that moment ("pain now")
timeFrame: the second and the tenth day and at the three months.
Secondary outcomes:
measure: If sexual intercourse had been re initiated, how long after childbirth, if pain had been experienced the first time and if this continued.
timeFrame: at the three months.
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Fundación Hospital Príncipe de Asturias
state: Madrid
Study officials:
affiliation: Hospital Prínicpe de Asturias
name: Pedro Valenzuela, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/S0140-6736(02)09312-1.
citation: 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.