| Trial name or title | Randomised controlled trial of restrictive versus routine use of episiotomy for instrumental vaginal delivery: a multi-centre pilot study |
| Methods | Randomised controlled trial. Random allocation to: [A] Restrictive use of episiotomy for instrumental vaginal delivery. [B] Routine use of episiotomy for instrumental vaginal delivery |
| Participants | The study aims to recruit 200 women. Inclusion criteria: primigravid women in the third trimester of pregnancy (>36 weeks) with a singleton cephalic pregnancy who are English speakers and have no contra-indication to vaginal birth. Exclusion criteria: Women who are: non-English speakers; who have contra-indication to vaginal birth; multiple pregnancy; malpresentation; multiparous women as the rate ofinstrumental delivery is significantly lower in these women making the effort of recruitment unjustified; women who have not given written informed consent prior to the onset of labour |
| Interventions | Random allocation to: [A] Restrictive use of episiotomy for instrumental vaginal delivery. [B] Routine use of episiotomy for instrumental vaginal delivery |
| Outcomes | Damage to the anal sphincter (third or fourth degree tears). |
| Starting date | 01/09/2005 |
| Contact information | Miss B Strachan Department of Obstetrics and Gynaecology St Michael’s Hospital Bristol BS2 8EG Telephone: 0117 928 5594 Fax: 0117 928 5180 E-mail: bryony.strachan@ubht.swest.nhs.uk |
| Notes |