Abstract
BackgroundBiomarkers of placental function can potentially aid the diagnosis and prediction of pregnancy complications. This randomised controlled pilot trial assessed whether for women with reduced fetal movement (RFM), intervention directed by the measurement of a placental biomarker in addition to standard care was feasible and improved pregnancy outcome compared with standard care alone.MethodsWomen aged 16–50 years presenting at eight UK maternity units with RFM between 36+0 and 41+0 weeks’ gestation with a viable singleton pregnancy and no indication for immediate delivery were eligible. Participants were randomised 1:1 in an unblinded manner to standard care and a biomarker blood test result revealed and acted on (intervention arm) or standard care where the biomarker result was not available (control arm). The objectives were to determine the feasibility of a main trial by recruiting 175–225 participants over 9 months and to provide proof of concept that informing care by measurement of placental biomarkers may improve outcome. Feasibility was assessed via the number of potentially eligible women, number recruited, reasons for non-recruitment and compliance. Proof of concept outcomes included the rates of the induction of labour and caesarean birth, and a composite adverse pregnancy outcome.ResultsOverall, 2917 women presented with RFM ≥ 36 weeks, 352 were approached to participate and 216 (61%) were randomised (intervention n = 109, control n = 107). The main reason for not approaching women was resource/staff issues (n = 1510). Ninety-seven women declined the trial, mainly due to not liking blood tests (n = 24) or not wanting to be in a trial (n = 21). Compliance with the trial interventions was 100% in both arms. Labour was induced in 97 (45%) participants (intervention n = 49, control n = 48), while 17 (9%) had planned caesarean sections (intervention n = 9, control n = 8). Overall, 9 (8%) babies in the intervention arm had the composite adverse pregnancy outcome versus 4 (4%) in the control arm.ConclusionsA main trial using a placental biomarker in combination with delivery, as indicated by the biomarker, in women with RFM is feasible. The frequency of adverse outcomes in this population is low, hence, a large sample size would be required along with consideration of the most appropriate outcome measures.Trial registrationISRCTN, ISRCTN12067514; registered 8 September 2017.
Highlights
In 2015, the stillbirth rate in the UK ranked 24th out of 49 high-income countries [1] and while the rate has declined over recent years [2], further reduction is a national priority [3]
A main trial using a placental biomarker in combination with delivery, as indicated by the biomarker, in women with reduced fetal movement (RFM) is feasible
The Stillbirth Priority Setting Partnership [13] identified two priorities relevant to RFM and placental dysfunction: (i) “which investigations identify a fetus at risk of stillbirth after a mother has experienced RFM” and (ii) “how can the structure and function of the placenta be assessed during pregnancy to detect potential problems and reduce the risk of stillbirth?” Research into this area needs to balance the possibility of increasing perinatal morbidity and mortality by intervening to deliver babies too early versus the increased risk of stillbirth at later gestational ages [14]
Summary
In 2015, the stillbirth rate in the UK ranked 24th out of 49 high-income countries [1] and while the rate has declined over recent years [2], further reduction is a national priority [3]. A systematic review identified three studies including 3475 participants to assess the effectiveness of measuring placental biomarkers to improve pregnancy outcome and concluded there was insufficient evidence to draw any conclusions [15]. Studies to evaluate the potential benefit of assessing placental dysfunction via a novel biomarker in combination with delivery, as indicated by the biomarker, in women with RFM at or after 36 weeks’ gestation are warranted. Biomarkers of placental function can potentially aid the diagnosis and prediction of pregnancy complications This randomised controlled pilot trial assessed whether for women with reduced fetal movement (RFM), intervention directed by the measurement of a placental biomarker in addition to standard care was feasible and improved pregnancy outcome compared with standard care alone. Proof of concept outcomes included the rates of the induction of labour and caesarean birth, and a composite adverse pregnancy outcome
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