Contact information
Type
Scientific
Primary contact
Dr Christine Louise Roberts
ORCID ID
Contact details
Building D02
University of Sydney
Sydney
2006
Australia
+61 2 9351 7738
christine.roberts@perinatal.usyd.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Added 19/07/10:
Most women use some method of pain relief during labour. There is extensive research evidence available of pharmacological pain relief during labour; however this evidence is not readily available to pregnant women. Decision aids are tools that present evidence based information and allow preference elicitation.
We developed a decision aid for labour analgesia for primiparous women planning a vaginal delivery. The aim of the decision aid was to reduce decisional conflict (uncertainty regarding which option to use), increase labour analgesia knowledge, without increasing anxiety and increase satisfaction with decision making in regards to labour analgesia. We tested the effectiveness of the decision aid in a randomised controlled trial.
Ethics approval
Added 19/07/10:
1. Central Sydney Area Health Service Ethics Review Committee (ref: X02-0247)
2. University of Sydney Human Ethics Committee (ref: 3419)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Pregnancy
Intervention
Two interventions: decision aid (evidenced based booklet of labour analgesia) and audio decision aid (evidenced based booklet, and accompanying audio CD).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Decisional conflict (uncertainty about which preference to choose) will be assessed by the Decisional Conflict Scale which has established reliability, good psychometric properties and is short (16 items). It has been used to evaluate a range of decision aids .
2. Measures of knowledge and realistic expectations about labour analgesia options and the benefits and risks of these options will be specific to this project. Thus we will need to develop, and test these measures as part of the project.
3. Anxiety will be measured by the state component of the short Spielberger anxiety scale which has been extensively used and validated [30,32]. We do not anticipate the decision aid will increase women's anxiety but it is important to document any changes in anxiety associated with the decision aid.
4. Satisfaction with analgesia decisions will be assessed using the Satisfaction with Decision Scale - a very brief six item scale with high reliability was developed specifically to assess satisfaction with health care decisions
Satisfaction with the decision and anxiety will be measured again at 1216 weeks postpartum. This interval was chosen to avoid the potential bias arising from questioning women still in the hospital who may feel a disloyalty to their caregivers by a critical appraisal and whose opinions have been shown to be more positive and short-lived than those obtained further out from the birth itself [34]. At that time we will also ask about exposure to the decision aid (to assess contamination), support during labour and use of pain relief methods prior to hospital admission. These issues will be further explored in the sample selected for in-depth interview.
Secondary outcome measures
Service utilisation outcomes:
The aim of the decision aid is to assist preference elicitation, and not to influence the direction of the decisions taken. Nevertheless, it is important to collect service utilisation and pregnancy outcome data so we will record and compare the pain relief methods used by women in all arms of the study, as well as recording and comparing rates of pregnancy complications and perinatal outcomes. The latter will be obtained (with informed consent) from the existing computerised obstetric database and include:
1. Medical or obstetric complications
2. Induction or augmentation of labour
3. Mode of delivery (vaginal, emergency or planned CS)
4. Enrolment to delivery interval
5. Gestational age
6. Birthweight
7. Apgar scores
8. Perinatal deaths
9. Neonatal Intensive Care Unit admission
10. Length of stay
Overall trial start date
01/09/2004
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Primiparous women who are ≥36 weeks gestation
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600
Participant exclusion criteria
1. Women who will not have any choice about analgesia, for example planned caesarean section (eg breech, placenta praevia, HIV)
2. Planned epidural (eg symptomatic heart disease)
3. Contraindications to analgesia (e.g drug sensitivities, anticoagulants, thrombocytopaenia)
Recruitment start date
01/09/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Australia
Trial participating centre
Building D02
Sydney
2006
Australia
Funders
Funder type
Research council
Funder name
National Health and Medical Research Council of Australia (Australia) (#253635)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
1. 2004 protocol on http://www.ncbi.nlm.nih.gov/pubmed/15588303
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20377844
Publication citations
-
Protocol
Roberts CL, Raynes-Greenow CH, Nassar N, Trevena L, McCaffery K, Protocol for a randomised controlled trial of a decision aid for the management of pain in labour and childbirth [ISRCTN52287533]., BMC Pregnancy Childbirth, 2004, 4, 1, 24, doi: 10.1186/1471-2393-4-24.
-
Results
Raynes-Greenow CH, Nassar N, Torvaldsen S, Trevena L, Roberts CL, Assisting informed decision making for labour analgesia: a randomised controlled trial of a decision aid for labour analgesia versus a pamphlet., BMC Pregnancy Childbirth, 2010, 10, 15, doi: 10.1186/1471-2393-10-15.