Newcastle Twin Antenatal Programme (TAP): a randomised controlled trial (RCT) study

ISRCTN ISRCTN38691965
DOI https://doi.org/10.1186/ISRCTN38691965
Protocol serial number RRCC/01F/31
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
Funder NHS Executive Northern and Yorkshire (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
24/02/2015
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

Mrs Debbie Sen
Scientific

19 Tankerville Terrace
Jesmond
Newcastle upon Tyne
NE2 3AJ
United Kingdom

Phone +44 (0)191 281 6160
Email abc@email.com

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleNewcastle Twin Antenatal Programme (TAP): a randomised controlled trial (RCT) study
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPostnatal depression
Intervention1. Twin antenatal programme
2. Women with twins receiving standard care
Intervention typeBehavioural
Primary outcome measure(s)

Post-natal depression

Key secondary outcome measure(s)

1. Maternal anxiety
2. Emotional well-being
3. Maternal satisfaction
4. Parental stress.

Completion date10/01/2003

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexFemale
Key inclusion criteriaWomen who have given birth to healthy babies
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment10/01/2001
Date of final enrolment10/01/2003

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

19 Tankerville Terrace
Newcastle upon Tyne
NE2 3AJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2014 Yes No