A randomised controlled trial of two decision aids for mode of delivery among women with a previous caesarean section
| ISRCTN | ISRCTN84367722 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84367722 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/07/2004
- Registration date
- 07/09/2004
- Last edited
- 10/02/2010
- 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 Alan Montgomery
Scientific
Scientific
Division of Primary Health Care
University of Bristol
Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom
| Phone | +44 (0)1179546642 |
|---|---|
| alan.a.montgomery@bristol.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | The DiAMOND trial (Decision Aids for Mode Of Next Delivery) |
| Study objectives | Women who have experienced a previous caesarean section are faced with a difficult decision between repeat elective caesarean section and trial of vaginal delivery in subsequent pregnancies. The aim of this study is to investigate two different methods of assisting pregnant women reach a decision about mode of delivery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy, with one previous caesarean section |
| Intervention | 1. Decision analysis This firstly requires elicitation of utilities (preference values) from women regarding the possible outcomes of both planned vaginal delivery and repeat elective caesarean section. Utilities will be measured via a computerised interview. These utilities will then be combined with probabilities of each outcome in a decision analysis tree. Each woman will be given a computer printout of the outcome of the decision analysis, a recommended 'preferred option' based on maximised expected utility. 2. Interactive information programme This is an innovative way of providing information about the outcomes and associated risks and benefits involved in the decision. Unlike a videotape or written information, the programme will allow women to more easily tailor the information they view, and sections can be interrupted or repeated as required. The sections viewed are recorded. In addition, women in this group will be given a password that will allow them to access the information programme via the internet as often as they wish. An important difference from the decision analysis intervention is that women¿s preferences are not explicitly sought and there is no recommendation of a 'preferred option' for the individual. 3. Usual care This will comprise standard care given by the obstetric and midwifery team. Women allocated to decision analysis or information programme will receive these interventions in addition to usual care. |
| Intervention type | Other |
| Primary outcome measure | 1. Actual mode of delivery 2. Decisional Conflict at 37 weeks gestation |
| Secondary outcome measures | 1. Anxiety 2. Knowledge 3. Perception of shared decision making 4. Satisfaction with decision making process 5. Proportion of women attempting vaginal delivery |
| Overall study start date | 01/05/2004 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 660 |
| Key inclusion criteria | Pregnant women with one previous lower segment caesarean section, no current obstetric problems and delivery expected at ≥37 weeks. Recruitment will take place during the initial booking visit at approximately 12-14 weeks' gestation. Participating centres are maternity units at St Michaels and Southmead Hospitals in Bristol, and Ninewells Hospital in Dundee. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Division of Primary Health Care
Bristol
BS6 6JL
United Kingdom
BS6 6JL
United Kingdom
Sponsor information
University of Bristol (UK)
University/education
University/education
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
| Website | http://www.bristol.ac.uk |
|---|---|
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Charity
The BUPA Foundation (UK) (ref 657/G10)
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 | protcol | 10/12/2004 | Yes | No | |
| Results article | results | 23/06/2007 | Yes | No | |
| Other publications | economic evaluation | 01/07/2010 | Yes | No |
