Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
24/02/2015
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

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes