Edinburgh Clinical Trials

AFFIRM

Does promoting increased awareness of decreased foetal movements reduce stillbirth, a stepped wedge cluster randomised trial.

The aim of this study is to test the hypothesis that a package of interventions consisting of strategies for increasing pregnant women’s awareness of the need to report early when they perceive a reduction in fetal movements, followed with a management plan for identification and delivery of the “at risk” fetus in such women, will reduce rates of stillbirth.

 

AFFIRM logo

Chief Investigator: Professor Jane Norman

Number and location of participating sites (by region/ country): UK 32 sites; Republic of Ireland 4 sites

 

ISRCTN number: NCTT01777022

 

Funder: Chief Scientist Office, Scottish Government

Start and End date of grant award: 01/07/2013 - 31/12/2016

 

Current Status: Published

 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31543-5/fulltext

 

Sponsor: NHS Lothian and University of Edinburgh - ACCORD

Chief Investigator: Professor Jane E Norman, University of Edinburgh MRC Centre for Reproductive Health, Queen's Medical Research Centre, 47 Little France Crescent, Edinburgh, EH16 4TY.

Trial manager: Sonia Whyte

 

ECTU Involvement: Statistics and randomisation service