Condition category
Pregnancy and Childbirth
Date applied
15/08/2005
Date assigned
02/09/2005
Last edited
13/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (ref: G106/919) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. Sanders J, Campbell R, Peters TJ, Effectiveness of pain relief during perineal suturing., BJOG, 2002, 109, 9, 1066-1068.

  2. 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.

  3. 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.

Additional files

Editorial Notes