Pregnancy Pregnancy and Childbirth
Conditions
Interventions
Two interventions: decision aid (evidenced based booklet of labour analgesia) and audio decision aid (evidenced based booklet, and accompanying audio CD).
Sponsors
Australian National Health and Medical Research Council (Australia)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Primiparous women who are =36 weeks gestation
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia
Outcome results
None listed