Condition category
Pregnancy and Childbirth
Date applied
21/07/2004
Date assigned
07/09/2004
Last edited
10/02/2010
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 Alan Montgomery

ORCID ID

Contact details

Division of Primary Health Care
University of Bristol
Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom
+44 (0)1179546642
alan.a.montgomery@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

The DiAMOND trial (Decision Aids for Mode Of Next Delivery)

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/05/2004

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

660

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2004

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Primary Health Care
Bristol
BS6 6JL
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

http://www.bristol.ac.uk

Funders

Funder type

Charity

Funder name

The BUPA Foundation (UK) (ref 657/G10)

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 protcol in http://www.ncbi.nlm.nih.gov/pubmed/15588324
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17540908
3. 2010 economic evaluation in http://www.ncbi.nlm.nih.gov/pubmed/20133502

Publication citations

  1. Protcol

    Montgomery AA, , The DiAMOND trial protocol: a randomised controlled trial of two decision aids for mode of delivery among women with a previous caesarean section [ISRCTN84367722]., BMC Pregnancy Childbirth, 2004, 4, 1, 25, doi: 10.1186/1471-2393-4-25.

  2. Results

    Montgomery AA, Emmett CL, Fahey T, Jones C, Ricketts I, Patel RR, Peters TJ, Murphy DJ, , Two decision aids for mode of delivery among women with previous caesarean section: randomised controlled trial., BMJ, 2007, 334, 7607, 1305, doi: 10.1136/bmj.39217.671019.55.

  3. Economic evaluation

    Hollinghurst S, Emmett C, Peters TJ, Watson H, Fahey T, Murphy DJ, Montgomery A, Economic evaluation of the DiAMOND randomized trial: cost and outcomes of 2 decision aids for mode of delivery among women with a previous cesarean section., Med Decis Making, 30, 4, 453-463, doi: 10.1177/0272989X09353195.

Additional files

Editorial Notes