Norman JE, et al. - In this AFFIRM study, researchers tested the premise that introduction of a reduced fetal movement (RFM), care package for pregnant women and clinicians that increased women's awareness of the need for prompt reporting of RFM and that standardised management, including timely delivery, would alter the incidence of stillbirth. The risk of stillbirths was not decreased by the RFM care package. Findings revealed that the benefits of a policy that promotes awareness of RFM stay doubtful.

Methods

• It was a stepped wedge, cluster-randomised trial.
• This trial was conducted in the UK and Ireland.
• Using a computer-generated allocation scheme, taking part maternity hospitals were grouped and randomised to one of nine intervention implementation dates (at 3 month intervals).
• Before the implementation date, this date was concealed from clusters and the trial team until 3 months.
• Each participating hospital had 3 observation periods:
  • A control period from Jan 1, 2014, until randomised date of intervention initiation;
  • A washout period from the implementation date and for 2 months;
  • The intervention period from the end of the washout period until Dec 31, 2016.
• Treatment allocation was not concealed from taking an interest women and caregivers.
• Researchers derived data from observational maternity data.
• Incidence of stillbirth was the primary outcome.
• The primary analysis was done according to the intention-to-treat principle, with births analysed according to whether they took place during the control or intervention periods, regardless of whether the intervention had been executed as planned.

Results

• As per data, 37 hospitals were enrolled.
• Researchers reported that 4 hospitals declined participation, and 33 hospitals were randomly assigned to an intervention implementation date.
• Data were gathered from 409,175 pregnancies (157,692 deliveries during the control period, 23,623 deliveries in the washout period, and 227,860 deliveries in the intervention period) between Jan 1, 2014, and Dec, 31, 2016.
• During the control period, the incidence of stillbirth was 4·40 per 1000 births.
• In the intervention period (adjusted odds ratio [aOR] 0·90, 95% CI 0·75–1·07; p=0·23), the incidence of stillbirth was 4·06 per 1000 births.