Randomised controlled trial of restrictive versus routine use of episiotomy for instrumental delivery - a multicentre pilot study
| ISRCTN | ISRCTN69736659 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69736659 |
| Protocol serial number | T03/23 |
| Sponsor | University of Dundee (UK) |
| Funder | Tenovus Scotland T03/23 |
- Submission date
- 19/01/2006
- Registration date
- 20/04/2006
- Last edited
- 07/12/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Deirdre Murphy
Scientific
Scientific
Division of Maternal and Child Health Sciences
University of Dundee
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
| Phone | +44 (0)1382 496703 |
|---|---|
| d.j.murphy@dundee.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled, multicentre pilot study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Aim to assess the effects of restrictive use of episiotomy compared with routine use during instrumental vaginal delivery |
| Ethics approval(s) | Ethical approval granted on 12/08/2004, reference number 04/MRE10/29 |
| Health condition(s) or problem(s) studied | Instrumental vaginal delivery |
| Intervention | Restrictive versus routine use of episiotomy |
| Intervention type | Other |
| Primary outcome measure(s) |
Third or fourth degree perineal tears |
| Key secondary outcome measure(s) |
1. Mother's perception of pain |
| Completion date | 31/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Primgravidae 2. Singleton 3. Cephalic presentation 4. At term ( >37 weeks gestation) 5. No contraindications to vaginal delivery |
| Key exclusion criteria | 1. Poor English 2. Maternal age <16 years 3. Inability to provide informed consent |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 31/08/2006 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Division of Maternal and Child Health Sciences
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2008 | Yes | No |
