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

Armstrong-Buisseret, Lindsay; Godolphin, Peter J.; Bradshaw, Lucy; Mitchell, Eleanor; Ratcliffe, Sam; Storey, Claire; Heazell, Alexander E. P.

Abstract

Background

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.

Methods

Women 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.

Results

Overall, 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.

Conclusions

A 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.

Citation

Armstrong-Buisseret, L., Godolphin, P. J., Bradshaw, L., Mitchell, E., Ratcliffe, S., Storey, C., & Heazell, A. E. P. (2020). 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. Pilot and Feasibility Studies, 6, Article 23. https://doi.org/10.1186/s40814-020-0561-z

• Journal Article Type: Article
• Acceptance Date: Jan 29, 2020
• Online Publication Date: Feb 13, 2020
• Publication Date: 2020-12
• Deposit Date: Nov 27, 2020
• Publicly Available Date: Dec 1, 2020
• Journal: Pilot and Feasibility Studies
• Electronic ISSN: 2055-5784
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 6
• Article Number: 23
• DOI: https://doi.org/10.1186/s40814-020-0561-z
• Public URL: https://nottingham-repository.worktribe.com/output/5071642
• Publisher URL: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-0561-z
• Additional Information: Received: 28 October 2019; Accepted: 29 January 2020; First Online: 13 February 2020; : Ethics approval for this trial was granted by the North West - Greater Manchester West Research Ethics Committee (Ref 17/NW/0014). All participants provided a full written informed consent before enrolment.; : Not applicable; : The authors declare that they have no competing interests.