A randomised controlled trial comparing standard or intensive management of reduced fetal movements after 36 weeks gestation-a feasibility study

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

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

“…We performed this study to address whether an RCT of the management of RFM in individual patients was an appropriate trial design, and was feasible with regard to i) maternal recruitment and retention ii) patient acceptability, iii) adherence to protocol. In addition, we wished to confirm the prevalence of poor perinatal outcomes in the study population [37]. ”…”

Standard care informed by the result of a placental growth factor blood test versus standard care alone in women with reduced fetal movement at or after 36+0 weeks’ gestation: a pilot randomised controlled trial

“…1) and in a main trial, options for increasing this could be included such as providing the opportunity to complete questionnaires online or text alerts sent before and after the questionnaire. These results have built on the initial findings from the ReMIT trial [16] and further demonstrate that a main trial to assess placental function via a biomarker in maternal blood in combination with delivery, as indicated by the biomarker, is feasible in women with RFM.…”

“…There was no difference in IOL and planned caesarean section rates between the two allocated trial arms, and the frequency of IOL for RFM was very similar. Interestingly, the proportion of IOL recommended by the sFlt-1/PlGF ratio was comparable with the proportion having IOL based on the hPL result in the ReMIT trial (27% versus 30% [16];) although the numbers are too small to draw any conclusions and it is plausible that a similar proportion of cases had evidence of placental dysfunction.…”

“…The multicentre randomised controlled Reduced Fetal Movement Intervention-2 (ReMIT-2) pilot trial reported here was based on the design of a single-centre randomised controlled feasibility trial (ReMIT) which investigated the intensive management of RFM via ultrasound scan and measurement of human placental lactogen (hPL) as a biomarker of placental dysfunction versus standard care [16]. The results showed that this type of trial was feasible with good compliance to the trial intervention (100% in both arms) and a potential improvement in proof of concept outcomes [16]. However, during the design stage of ReMIT-2, we evaluated whether prospective sites throughout the UK could test for hPL and determined this would not be viable in a multicentre trial due to the resource-intensive nature of the assay and the need for results to be available within 24 h.…”

Use of the Myocardial Performance Index in Decreased Fetal Movement Assessment: A Case-Control Study

“…DFM is a common obstetric presentation associated with stillbirth, and current routine ultrasound measures are inadequate predictors of DFM-associated adverse perinatal outcomes [2,3,8,9,26,27]. To our knowledge, this is the first study to evaluate MPI use in DFM.…”