Contact information
Type
Scientific
Primary contact
Mrs Debbie Sen
ORCID ID
Contact details
19 Tankerville Terrace
Jesmond
Newcastle upon Tyne
NE2 3AJ
United Kingdom
+44 (0)191 281 6160
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRCC/01F/31
Study information
Scientific title
Newcastle Twin Antenatal Programme (TAP): a randomised controlled trial (RCT) study
Acronym
Study hypothesis
The primary hypothesis of the study is that the incidence of postnatal depression is reduced in women participating in a twin antenatal programme compared to women with twins in a control group receiving standard care and relative to women expecting one baby receiving standard care.
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
Prevention
Patient information sheet
Condition
Postnatal depression
Intervention
1. Twin antenatal programme
2. Women with twins receiving standard care
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Post-natal depression
Secondary outcome measures
1. Maternal anxiety
2. Emotional well-being
3. Maternal satisfaction
4. Parental stress.
Overall trial start date
10/01/2001
Overall trial end date
10/01/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Women who have given birth to healthy babies
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
10/01/2001
Recruitment end date
10/01/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
19 Tankerville Terrace
Newcastle upon Tyne
NE2 3AJ
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24835579