Trial reportBMJ open2018
Prediabetes in pregnancy, can early intervention improve outcomes? A feasibility study for a parallel randomised clinical trial.
Trial report in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 24 citations in OpenAlex.
- Navigating Diabetes in Pregnancy: Critical Approaches to Mitigate Risks and Improve Outcomes for Mother and Child.Metabolites · 2025Review
- Time to Move Beyond a Binary Criterion for Gestational Diabetes?Reproductive sciences (Thousand Oaks, Calif.) · 2024Review
- Electronic Monitoring Of Mom's Schedule (eMOMSPreventive medicine reports · 2023Article
- Early screening for gestational diabetes mellitus: a meta-analysis of randomized controlled trials.American journal of obstetrics & gynecology MFM · 2022Review
- Article
- Early Gestational Diabetes Mellitus: Diagnostic Strategies and Clinical Implications.Medical sciences (Basel, Switzerland) · 2021Review
- Review of Prediabetes and Hypertensive Disorders of Pregnancy.American journal of perinatology · 2021Review
- Screening for Gestational Diabetes Mellitus in Early Pregnancy: What Is the Evidence?Journal of clinical medicine · 2021Review
- An Update on Screening Strategies for Gestational Diabetes Mellitus: A Narrative Review.Diabetes, metabolic syndrome and obesity : targets and therapy · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveMeasurement of glycated haemoglobin (HbA1c) in early pregnancy is routine in New Zealand to identify women with diabetes and prediabetes. However, the benefit of early intervention in women with prediabetes is inconclusive. Our aim was to test the feasibility of a two-arm parallel randomised controlled trial of standard care versus early intervention in pregnancies complicated by prediabetes.
settingTwo tertiary referral centres in New Zealand.
participantsWomen <14 weeks' gestation and HbA1c ≥5.9%-6.4% (41-46 mmol/mol) measured at booking, without pre-existing diabetes.
interventionsRandomisation was done by remote web-based allocation into one of two groups. Women in the early intervention group attended an antenatal diabetes clinic, commenced daily home blood glucose monitoring, and medication was prescribed if lifestyle measures failed to maintain target blood glucose levels. Controls received lifestyle education, continued standard care with their midwife and/or obstetrician, and were asked to perform a 75 g oral glucose tolerance test at 24 weeks' gestation with a referral to clinic if this test was positive. Both groups received lifestyle questionnaires at recruitment and in late pregnancy. OUTCOME MEASURES: Recruitment rate, adherence to protocol and validation of potential primary outcomes.
resultsRecruitment rates were lower than expected, especially in Māori and Pacific women. Non-adherence to allocated treatment protocol was significant, 42% (95% CI 24% to 61%) in the early intervention group and 30% (95% CI 16% to 51%) in controls. Caesarean section and pre-eclampsia were signalled as potential primary outcomes, due to both the high observed incidence in the control group and ease of measurement.
conclusionsFor a future definitive trial, extending the gestation of eligibility and stepped-wedge cluster randomisation may overcome the identified feasibility issues. Consistent with published observational data, pre-eclampsia and emergency caesarean section could be included as primary outcome measures, both of which have a significant impact on maternal and neonatal morbidity and healthcare costs. TRIAL REGISTRATION NUMBER: ACTRN12615000904572; Pre-results.
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