Contact information
Type
Scientific
Primary contact
Dr Julia Sanders
ORCID ID
Contact details
Midwifery led Unit
University Hospital of Wales
Heath Park
Cardiff
CF14 4XN
United Kingdom
+44 (0)29 2074 5030/3017
julia.sanders@cardiffandvale.wales.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G106/919
Study information
Scientific title
Acronym
The Crowning Study
Study hypothesis
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
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.
Study design
Randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Local anaesthetic
Primary outcome measures
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 trial start date
10/03/2003
Overall trial end date
16/05/2004
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
170
Participant 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.
Recruitment start date
10/03/2003
Recruitment end date
16/05/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Midwifery led Unit
Cardiff
CF14 4XN
United Kingdom
Funders
Funder type
Research council
Funder name
Medical Research Council (ref: G106/919) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
Wellbeing of Women (ref: NBTF/408) (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12269684
2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15878430
3. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16807257
Publication citations
-
Sanders J, Campbell R, Peters TJ, Effectiveness of pain relief during perineal suturing., BJOG, 2002, 109, 9, 1066-1068.
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Sanders J, Peters TJ, Campbell R, Techniques to reduce perineal pain during spontaneous vaginal delivery and perineal suturing: a UK survey of midwifery practice., Midwifery, 2005, 21, 2, 154-160, doi: 10.1016/j.midw.2004.12.003.
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Sanders J, Campbell R, Peters TJ, Effectiveness and acceptability of lidocaine spray in reducing perineal pain during spontaneous vaginal delivery: randomised controlled trial., BMJ, 2006, 333, 7559, 117, doi: 10.1136/bmj.38878.833241.7C.