Study of Different Suturing Techniques for Perineal Repair After Delivery

University of Aarhus400 enrolled

Overview

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.

A randomised controlled trial with 400 participants was initiated in August 2004. The two suture techniques compared were both 2-layered and either continuous sutures or interrupted, inverted stitches to perineal muscles and the subcuticular layer. A polyglactin 910 multifilament thread on an atraumatic needle was used and the perineal skin was left unsutured. Healthy primiparas \>36+0 weeks gestation could participate if they had a either a 2nd degree perineal laceration or an episiotomy. The trial was a double-blind and analysis was done on an intention-to-treat basis. Main outcomes were pain, wound healing and patient satisfaction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Perineal Lacerations Episiotomy

Interventions

Suture technique for perineal repair after deliveryPROCEDURE

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 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. Exclusion Criteria: 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.

Locations (1)

Dept. of Obstetrics and Gynaecology, Skejby Sygehus

Aarhus, Denmark

Outcomes

Primary Outcomes

Pain in perineal area day 1 and 10 after delivery.

Healing of wound day 1 and 10 after delivery.

Secondary Outcomes

Patient satisfaction with perineal sutures performed at birth.

Incontinence.

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

Data from ClinicalTrials.gov

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