title: A randomised controlled trial comparing standard or intensive management of reduced fetal movements after 36 weeks gestation--a feasibility study.
abstract: BACKGROUND
  Women 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.
  
  
  METHODS
  Women 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.
  
  
  RESULTS
  137 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.
  
  
  CONCLUSIONS
  An 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.
  
  
  BACKGROUND
  ISRCTN07944306.
authors.affiliation: Maternal and Fetal Health Research Centre, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. alexander.heazell@manchester.ac.uk
authors.forename: Alexander E P
authors.initials: AE
authors.lastname: Heazell
authors.forename: Giovanna
authors.initials: G
authors.lastname: Bernatavicius
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Roberts
authors.forename: Ainslie
authors.initials: A
authors.lastname: Garrod
authors.forename: Melissa K
authors.initials: MK
authors.lastname: Whitworth
authors.forename: Edward D
authors.initials: ED
authors.lastname: Johnstone
authors.forename: Joanna C
authors.initials: JC
authors.lastname: Gillham
authors.forename: Tina
authors.initials: T
authors.lastname: Lavender
mesh_terms: D000293:Adolescent; D000328:Adult; D001007:Anxiety / Q000209:etiology; D005240:Feasibility Studies; D005260:Female; D005316:Fetal Distress / Q000097:blood / Q000000981:diagnostic imaging / Q000628:therapy*; D005324:Fetal Movement; D005865:Gestational Age; D006801:Humans; D007751:Labor, Induced; D010349:Patient Compliance; D018579:Patient Selection; D010928:Placental Lactogen / Q000097:blood; D011247:Pregnancy; D011263:Pregnancy Trimester, Third; D050497:Stillbirth; D014463:Ultrasonography; D014469:Umbilical Arteries / Q000000981:diagnostic imaging; D055815:Young Adult
chemical_list: D010928:Placental Lactogen