Is surgical incision of the perineum of the mother routinely required for the delivery of her first baby?

• Register: SLCTR
• Last refreshed on: 27 May 2013
• Main ID: SLCTR/2008/007
• Date of registration: 16/05/2008
• Primary sponsor: Faculty of Medicine
• Public title: Is surgical incision of the perineum of the mother routinely required for the delivery of her first baby?
• Scientific title: Comparative study of restricted episiotomy vs routine episiotomy
• Date of first enrolment: 24/3/2008
• Target sample size: 288
• Recruitment status: Completed
• URL: http://www.slctr.lk/trial_details.asp?reg_id={6AB92473-E902-4D5E-8276-D7D670D191A8}
• Study type: Interventional
• Study design: Randomized controlled trial without binding

Countries of recruitment

Sri Lanka

Contacts

• Name: Prof. Malik Goonewardene
• Affiliation: Professor and Head of Department

• Name: Prof. Malik Goonewardene
• Affiliation: Professor and Head

Key inclusion & exclusion criteria

Inclusion criteria: Primi gravide with singleton pregnancy at 37-42 weeks of gestation and cephalic presentation
Exclusion criteria: Primi gravidae with any medical or obstetric complications

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Vaginal delivery in primi gravidae

Intervention(s)

In the study group an episiotomy will be given only if it is considered to be needed in order to prevent vaginal and perineal tears. In the  control group all will be given an episiotomy

Primary Outcome(s)

In the study group the reduction in the propotion of primi gravidae who will have an episiotomy

Secondary Outcome(s)

Posterior perineal trauma and its severity, anterior vaginal wall tears, perineal pain, haematoma formation, infection, stress urinary incontinence and dysparaeunea

Secondary ID(s)

Nil

Source(s) of Monetary Support

Nil