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
Protocol serial number	G106/919
Sponsor	University of Bristol (UK)
Funders	Medical Research Council (ref: G106/919) (UK), Wellbeing of Women (ref: NBTF/408) (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial.
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Local anaesthetic
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	16/05/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	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