Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

Abstract

SummaryBackground2·6 million pregnancies were estimated to have ended in stillbirth in 2015. The aim of the AFFIRM study was to test the hypothesis 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.MethodsThis stepped wedge, cluster-randomised trial was done in the UK and Ireland. Participating maternity hospitals were grouped and randomised, using a computer-generated allocation scheme, to one of nine intervention implementation dates (at 3 month intervals). This date was concealed from clusters and the trial team until 3 months before the implementation date. Each participating hospital had three 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; and the intervention period from the end of the washout period until Dec 31, 2016. Treatment allocation was not concealed from participating women and caregivers. Data were derived from observational maternity data. The primary outcome was incidence of stillbirth. 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, irrespective of whether the intervention had been implemented as planned. This study is registered with www.ClinicalTrials.gov, number NCT01777022.Findings37 hospitals were enrolled in the study. Four hospitals declined participation, and 33 hospitals were randomly assigned to an intervention implementation date. Between Jan 1, 2014, and Dec, 31, 2016, data were collected 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). The incidence of stillbirth was 4·40 per 1000 births during the control period and 4·06 per 1000 births in the intervention period (adjusted odds ratio [aOR] 0·90, 95% CI 0·75–1·07; p=0·23).InterpretationThe RFM care package did not reduce the risk of stillbirths. The benefits of a policy that promotes awareness of RFM remains unproven.FundingChief Scientist Office, Scottish Government (CZH/4/882), Tommy's Centre for Maternal and Fetal Health, Sands.

The outcomes of pregnancies with reduced fetal movements: A retrospective cohort study

“…The high rates of intervention, in the form of induction of labor and cesarean section, and of use of resources, in the form of admission and ultrasound, are clear. The AFFIRM study showed similar prelabor cesarean section rates and induction rates that were nearly as high . Less than 40% of women with recurrent RFM in our cohort have a spontaneous onset of labor, reflecting current advice in the UK in the Royal College of Obstetricians and Gynaecologists, Greentop Guideline 2011…”

“…It is accepted that SGA babies are over‐represented among pregnancies with RFM. The latter can be a presentation of fetal demise, for which SGA is a major risk factor . Without a control group, we cannot confirm this in our cohort of pregnancies.…”

“…It seems likely that the current concern over recurrent RFM, or perception of the risks in a baby who has normal CTG, particularly if the baby is once again moving normally, is exaggerated. This could contribute to the negative findings of the AFFIRM study, and lead to over‐intervention and infant morbidity or even mortality by iatrogenic preterm or early term birth …”

“…There is, however, the capacity to do harm, either by causing increased maternal anxiety or through obstetric intervention, by using resources, or by iatrogenic preterm or early term birth. A recent large trial with data from 409 175 pregnancies demonstrated no significant reduction in perinatal mortality, and an increase in cesarean section, with a package of maternal education and standardized, proactive clinical management …”

“…The evidence for this is limited, but the association has prompted advice for investigation and indeed intervention . “Recurrent” episodes constituted an indication for delivery from 37 weeks of gestation in the intervention package of the recent trial showing no benefit …”