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

Midwifery led Unit
University Hospital of Wales
Heath Park
Cardiff
CF14 4XN
United Kingdom

Phone +44 (0)29 2074 5030/3017
Email julia.sanders@cardiffandvale.wales.nhs.uk

Study information

Study designRandomised controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe effectiveness and acceptability of using a topically applied local anaesthetic to reduce perineal pain during the second stage of labour
Study acronymThe Crowning Study
Study objectivesThe 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) studiedChildbirth
InterventionApplication 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Local anaesthetic
Primary outcome measureThe 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 measuresDelivery:
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 date10/03/2003
Completion date16/05/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants170
Key inclusion criteriaThe 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 criteriaDuring 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 enrolment10/03/2003
Date of final enrolment16/05/2004

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Midwifery led Unit
Cardiff
CF14 4XN
United Kingdom

Sponsor information

University of Bristol (UK)
University/education

Department of Social Medicine
University of Bristol
Whiteladies Road
Bristol
BS8 2PR
England
United Kingdom

ROR logo "ROR" https://ror.org/0524sp257

Funders

Funder type

Research council

Medical Research Council (ref: G106/919) (UK)
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
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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