Abstract
BackgroundWomen presenting with reduced fetal movements (RFM) in the third trimester are at increased risk of stillbirth or fetal growth restriction. These outcomes after RFM are related to smaller fetal size on ultrasound scan, oligohydramnios and lower human placental lactogen (hPL) in maternal serum. We performed this study to address whether a randomised controlled trial (RCT) of the management of RFM was feasible with regard to: i) maternal recruitment and retention ii) patient acceptability, iii) adherence to protocol. Additionally, we aimed to confirm the prevalence of poor perinatal outcomes defined as: stillbirth, birthweight <10th centile, umbilical arterial pH <7.1 or unexpected admission to the neonatal intensive care unit.MethodsWomen with RFM ≥36 weeks gestation were invited to participate in a RCT comparing standard management (ultrasound scan if indicated, induction of labour (IOL) based on consultant decision) with intensive management (ultrasound scan, maternal serum hPL, IOL if either result was abnormal). Anxiety was assessed by state-trait anxiety index (STAI) before and after investigations for RFM. Rates of protocol compliance and IOL for RFM were calculated. Participant views were assessed by questionnaires.Results137 women were approached, 120 (88%) participated, 60 in each group, 2 women in the standard group did not complete the study. 20% of participants had a poor perinatal outcome. All women in the intensive group had ultrasound assessment of fetal size and liquor volume vs. 97% in the standard group. 50% of the intensive group had IOL for abnormal scan or low hPL after RFM vs. 26% of controls (p < 0.01). STAI reduced for all women after investigations, but this reduction was greater in the standard group (p = 0.02). Participants had positive views about their involvement in the study.ConclusionAn RCT of management of RFM is feasible with a low rate of attrition. Investigations decrease maternal anxiety. Participants in the intensive group were more likely to have IOL for RFM. Further work is required to determine the likely level of intervention in the standard care arm in multiple centres, to develop additional placental biomarkers and to confirm that the composite outcome is valid.Trial registrationISRCTN07944306
Highlights
Women presenting with reduced fetal movements (RFM) in the third trimester are at increased risk of stillbirth or fetal growth restriction
Cohort studies carried out on different populations have found that the investigations that best predicted poor perinatal outcome (including stillbirth, fetal growth restriction (FGR) and admission to the neonatal intensive care unit (NICU)) after Reduced fetal movements (RFM) were electronic fetal monitoring, ultrasound assessment of fetal weight and liquor volume and measurement of human placental lactogen in maternal serum [6,10]
This feasibility study suggests that a randomised controlled trial of the individualised management of RFM would be acceptable to women perceiving RFM after 36 weeks gestation and to professionals, given a participation rate of 87% and a dropout rate of
Summary
Women presenting with reduced fetal movements (RFM) in the third trimester are at increased risk of stillbirth or fetal growth restriction. RFM, defined by maternal perception of significantly reduced or absent fetal activity, is associated with increased risk of stillbirth and fetal growth restriction (FGR) due to placental dysfunction [3,4]. Despite this association there is a paucity of evidence to direct clinical management of women presenting with RFM. Cohort studies carried out on different populations have found that the investigations that best predicted poor perinatal outcome (including stillbirth, FGR and admission to the neonatal intensive care unit (NICU)) after RFM were electronic fetal monitoring, ultrasound assessment of fetal weight and liquor volume and measurement of human placental lactogen (hPL) in maternal serum [6,10]. Studies have adopted an approach of changing practice at the unit level in quality-improvement projects [6] or stepwise cluster RCT (AFFIRM, NCT01777022 [13])
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