Randomised controlled trial of a decision aid for primiparous women making decisions about labour analgesia

ISRCTN	ISRCTN52287533
DOI	https://doi.org/10.1186/ISRCTN52287533
Protocol serial number	N/A
Sponsor	Australian National Health and Medical Research Council (Australia)
Funder	National Health and Medical Research Council of Australia (Australia) (#253635)

Submission date: 10/08/2004
Registration date: 21/09/2004
Last edited: 19/07/2010

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 Christine Louise Roberts
Scientific

Building D02
University of Sydney
Sydney
2006
Australia

Phone	+61 2 9351 7738
Email	christine.roberts@perinatal.usyd.edu.au

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	600
Key inclusion criteria	Primiparous women who are ≥36 weeks gestation
Key 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)
Date of first enrolment	01/09/2004
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

Australia

Study participating centre

Building D02

Sydney
2006
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/04/2010		Yes	No
Protocol article	protocol	09/12/2004		Yes	No