MedDataX Logo

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

NCT ID: NCT00777270

Last Updated: 2008-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

445 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

episiotomy perineal lesion vaginal trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 continuous

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

Group Type EXPERIMENTAL

repair of episiotomy or second degree tears

Intervention Type PROCEDURE

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

repair of episiotomy or second degree tears

Intervention Type PROCEDURE

interrupted technique with continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture

2 interrupted

interrupted technique with continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture

Group Type EXPERIMENTAL

repair of episiotomy or second degree tears

Intervention Type PROCEDURE

interrupted technique with continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

repair of episiotomy or second degree tears

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

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

(Vicryl Rapid; Ethicon) (Vicryl Rapid; Ethicon).

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Universitario Principe de Asturias

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fundación Hospital Principe de Asturias

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pedro Valenzuela, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Prínicpe de Asturias

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fundación Hospital Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 12103284 (View on PubMed)

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.

Reference Type RESULT
PMID: 2406391 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FIS-PI051023

Identifier Type: -

Identifier Source: org_study_id