Clinical outcome reporting in randomised controlled trials of remote obstetric antenatal monitoring: a systematic review

BACKGROUND: Over the last decade, remote technological initiatives for obstetric antenatal care have rapidly developed. However, variation in outcome reporting can preclude effective data synthesis. A remedy for this is to develop of a core outcome set (COS). However, prior to this, it is necessary to examine the heterogeneity of outcome reporting.

METHODS: MEDLINE, Embase, Cochrane Database of Clinical Trials (CENTRAL), Web of Science, and PubMed databases from January 2015 to November 2025. Randomised controlled trials (RCTs), RCT protocols or pilot RCTs which assessed any outcome for any type of remote monitoring device during the obstetric antenatal period were included. Study characteristics, outcomes definitions and timings were extracted and descriptively analysed.

RESULTS: Of the 4904 papers screen, 40 studies were included (24 full RCTs, 10 protocols and six pilot RCTs) The most common remote monitoring devices used, either in isolation or in combination, were blood pressure (n = 17, 42.5%) and blood glucose (n = 16, 40.0%). In total, 1004 verbatim outcomes were noted, categorised into 361 unique outcomes, across 72 domains. Outcome definition was heterogenous, with glycaemic monitoring demonstrating the largest variation, with 29 different definitions. Longer-term outcomes were infrequently reported, with fewer than 6% of all outcomes evaluating more than 3 months postpartum. Maternal remote monitoring devices were most commonly assessed, with 29 studies solely evaluating these devices. No single outcome was reported in all studies.

CONCLUSION: This review demonstrates a lack of consistent outcome reporting for trials examining remote antenatal monitoring devices. Consequently, the development of a COS is recommended.