The effectiveness and acceptability of using a topically applied local anaesthetic to reduce perineal pain during the second stage of labour
| ISRCTN | ISRCTN99732966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99732966 |
| Secondary identifying numbers | G106/919 |
- Submission date
- 15/08/2005
- Registration date
- 02/09/2005
- Last edited
- 05/07/2018
- 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
Dr Julia Sanders
Scientific
Scientific
Midwifery led Unit
University Hospital of Wales
Heath Park
Cardiff
CF14 4XN
United Kingdom
| Phone | +44 (0)29 2074 5030/3017 |
|---|---|
| julia.sanders@cardiffandvale.wales.nhs.uk |
Study information
| Study design | Randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The effectiveness and acceptability of using a topically applied local anaesthetic to reduce perineal pain during the second stage of labour |
| Study acronym | The Crowning Study |
| Study objectives | The aim of this study was to rigorously assess the extent to which topically applying a local anaesthetic to the perineum during the second stage of labour reduced the pain experienced by women as their baby is born. The specific objectives were: 1. To investigate the effectiveness of topically applied local anaesthetic in reducing perineal pain during the second stage of labour 2. To evaluate the impact of this anaesthetic preparation on rates and severity of genital trauma 3. To assess the acceptability of this anaesthetic to women and to the midwives who applied it 4. To identify any risk to the baby of applying an anaesthetic to the perineum immediately before delivery |
| Ethics approval(s) | Added as of 13/08/2007: This trial was approved by the Medicines Control Agency, the local research ethics committee and the participating NHS trust research and development directorate. |
| Health condition(s) or problem(s) studied | Childbirth |
| Intervention | Application of a local anaesthetic spray or placebo spray, applied to the perineum shortly prior to spontaneous vaginal delivery. Each 0.1 ml of active trial solution was formulated to contain: Lidocaine 10 mg, Ethanol 95% 24.1 mg, Poly Ethylene Glycol (PEG 400) 30 mg, H2O to 0.1 ml |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Local anaesthetic |
| Primary outcome measure | The primary outcome was pain immediately prior to delivery as recorded on the 0-100 Numerical Rating Scale component of the Adapted McGill Pain Questionnaire (Short-Form) and the co-primary outcome the incidence and extent of perineal and other genital tract trauma. |
| Secondary outcome measures | Delivery: 1. Delivery pain as measured on the remaining components of the AMPQ-SF 2. Maternal satisfaction with delivery analgesia 3. Maternal control and satisfaction with delivery Neonatal: 1. Levels of lidocaine in cord blood 2. Condition at birth 3. Infant feeding practices Postnatal: 1. Perineal pain at one week and two months following delivery 2. Perineal problems two months following delivery 3. Maternal feelings two months post delivery as measured on the Edinburgh Postnatal Depression Scale 159 and Maternal Adjustment to Motherhood Scale |
| Overall study start date | 10/03/2003 |
| Completion date | 16/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 170 |
| Key inclusion criteria | The participants comprised nulliparous and parous women who had a live singleton fetus with cephalic presentation at term (more than or equal to 37 weeks gestation) and for whom a spontaneous vaginal delivery was considered imminent. |
| Key exclusion criteria | During the antenatal period, women falling into certain broad categories were excluded from the trial. These were: 1. Women with a multiple pregnancy 2. Women booked to have a caesarean section, instrumental delivery or episiotomy 3. Women who had previously experienced an adverse reaction to a local anaesthetic 4. Women with insufficient spoken or written English either to provide valid consent or to complete the study questionnaires Once in labour the following women were also excluded: a. Women whose pregnancy was less than 37 weeks gestation b. Women with epidural analgesia c. Women whose baby had a non-cephalic presentation d. Women for whom sensitivity dictated that they should not approached to participate in the trial (for example, women whose baby was expected to require immediate intensive neonatal care following delivery) were also not invited to participate. The decision whether or not to recruit an individual woman into the trial was made by the midwife providing care. |
| Date of first enrolment | 10/03/2003 |
| Date of final enrolment | 16/05/2004 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Midwifery led Unit
Cardiff
CF14 4XN
United Kingdom
CF14 4XN
United Kingdom
Sponsor information
University of Bristol (UK)
University/education
University/education
Department of Social Medicine
University of Bristol
Whiteladies Road
Bristol
BS8 2PR
England
United Kingdom
"ROR" |
https://ror.org/0524sp257 |
|---|
Funders
Funder type
Research council
Medical Research Council (ref: G106/919) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Wellbeing of Women (ref: NBTF/408) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/09/2002 | Yes | No | |
| Results article | results | 01/06/2005 | Yes | No | |
| Results article | results | 15/07/2006 | Yes | No |
Editorial Notes
05/07/2018: Internal review
