Randomised controlled trial of a decision aid for primiparous women making decisions about labour analgesia
| ISRCTN | ISRCTN52287533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52287533 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Building D02
University of Sydney
Sydney
2006
Australia
| Phone | +61 2 9351 7738 |
|---|---|
| christine.roberts@perinatal.usyd.edu.au |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| 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 | 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 study start date | 01/09/2004 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
2006
Australia
Sponsor information
Australian National Health and Medical Research Council (Australia)
Research council
Research council
Office of NHMRC (MDP 100)
GPO Box 9848
Canberra, ACT
2601
Australia
"ROR" |
https://ror.org/011kf5r70 |
|---|
Funders
Funder type
Research council
National Health and Medical Research Council of Australia (Australia) (#253635)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/12/2004 | Yes | No | |
| Results article | results | 08/04/2010 | Yes | No |
