Condition category
Pregnancy and Childbirth
Date applied
10/08/2004
Date assigned
21/09/2004
Last edited
19/07/2010
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 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 12–16 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

Sponsor information

Organisation

Australian National Health and Medical Research Council (Australia)

Sponsor details

Office of NHMRC (MDP 100)
GPO Box 9848
Canberra
ACT
2601
Australia

Sponsor type

Research council

Website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes