NCT00265421

Brief Summary

We wish to determine wich of two standardized suturing techniques is the best for perineal repair if a perineal laceration or an episiotomy is present after vaginal birth. The participants are healthy primi para and deliver at term.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

September 30, 2009

Status Verified

September 1, 2009

First QC Date

December 13, 2005

Last Update Submit

September 29, 2009

Conditions

Perineal LacerationsEpisiotomy

Keywords

Suture Techniques

Outcome Measures

Primary Outcomes (2)

  • Pain in perineal area day 1 and 10 after delivery.

  • Healing of wound day 1 and 10 after delivery.

Secondary Outcomes (3)

  • Patient satisfaction with perineal sutures performed at birth.

  • Incontinence.

  • Need for resuturing of perineal area within 1 year after delivery.

Interventions

Suture technique for perineal repair after deliveryPROCEDURE

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primipara, 2nd degree perineal laceration or episiotomy. Vaginal birth of one child in occipital position terminating a pregnancy at 36 weeks or later. A soft cup used to deliver the baby was accepted. Participants must be able to understand and speak Danish.

You may not qualify if:

  • Perineal 3rd or 4th degree injuries, post partum haemorrhage extending 1000 ml. or manual removal of placenta, former perineal wounds, foetus mortuus or delivery of a child immediately transferred to the neonatal ward, Diabetes Mellitus, instrumental delivery, Caesarean Section or gemelli.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Obstetrics and Gynaecology, Skejby Sygehus

Aarhus, 8200, Denmark

Location

MeSH Terms

Interventions

Suture Techniques

Intervention Hierarchy (Ancestors)

Wound Closure TechniquesSurgical Procedures, Operative

Study Officials

  • Niels Uldbjerg, Professor

    Aarhus University Hopspital, dept. of Obst. & Gyn.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2005

First Posted

December 14, 2005

Study Start

August 1, 2004

Study Completion

April 1, 2006

Last Updated

September 30, 2009

Record last verified: 2009-09

Locations

DK(1)