|
ISRCTN
|
ISRCTN38691965
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Newcastle Twin Antenatal Programme (TAP) a randomised controlled trial (RCT) Study
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
RRCC/01F/31
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Postnatal depression
|
|
Participants - inclusion criteria
|
Women who have given birth to healthy babies
|
|
Participants - exclusion criteria
|
Does not match inclusion criteria
|
|
Anticipated start date
|
10/01/2001
|
|
Anticipated end date
|
10/01/2003
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
1. Twin antenatal programme
2. Women with twins receiving standard care
|
|
Primary outcome measure(s)
|
Post-natal depression
|
|
Secondary outcome measure(s)
|
1. Maternal anxiety
2. Emotional well-being
3. Maternal satisfaction
4. Parental stress.
|
|
Sources of funding
|
NHS Executive Northern and Yorkshire (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mrs
Debbie
Sen
|
|
Address
|
19 Tankerville Terrace
Jesmond
|
|
City/town
|
Newcastle upon Tyne
|
|
Zip/Postcode
|
NE2 3AJ
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)191 281 6160
|
|
Email
|
|
|
Sponsor
|
NHS R&D Regional Programme Register - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.doh.gov.uk
|
|
Date applied
|
23/01/2004
|
|
Last edited
|
11/01/2010
|
|
Date ISRCTN assigned
|
23/01/2004
|
