The effectiveness and acceptability of using a topically applied local anaesthetic to reduce perineal pain during the second stage of labour

Not Applicable

Completed

• Conditions: Pregnancy and Childbirth; Childbirth

• Registration Number: ISRCTN99732966
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

1. 2002 results in https://www.ncbi.nlm.nih.gov/pubmed/12269684?dopt=Abstract 2. 2005 results in https://www.ncbi.nlm.nih.gov/pubmed/15878430?dopt=Abstract 3. 2006 results in https://www.ncbi.nlm.nih.gov/pubmed/16807257?dopt=Abstract

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2004-05-16
• Study Start: 2005-09-02
• Last Update Posted: 30 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 170

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Delivery:<br>1. Delivery pain as measured on the remaining components of the AMPQ-SF<br>2. Maternal satisfaction with delivery analgesia<br>3. Maternal control and satisfaction with delivery <br><br>Neonatal:<br>1. Levels of lidocaine in cord blood<br>2. Condition at birth<br>3. Infant feeding practices <br><br>Postnatal:<br>1. Perineal pain at one week and two months following delivery<br>2. Perineal problems two months following delivery<br>3. Maternal feelings two months post delivery as measured on the Edinburgh Postnatal Depression Scale 159 and Maternal Adjustment to Motherhood Scale