Trial reportThe journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians2014
Poor pregnancy outcome in women with type 1 diabetes is predicted by elevated HbA1c and spikes of high glucose values in the third trimester.
Trial report in The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00365170 (A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, Focusing on Maternal Hypoglycaemia and Pregnancy Outcomes
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 65 citations in OpenAlex.
- Preconception care for diabetic women for improving maternal and infant health.The Cochrane database of systematic reviews · 2017Pooled it
- Different insulin types and regimens for pregnant women with pre-existing diabetes.The Cochrane database of systematic reviews · 2017Pooled it
- Women's Experiences of Day-and-Night Closed-Loop Insulin Delivery During Type 1 Diabetes Pregnancy.Journal of diabetes science and technology · 2018Trial
- Pregnancy Outcomes in Women with Type 1 Diabetes by Socioeconomic and Mental Health Disadvantages.Clinical epidemiology · 2026Article
- Maternal and Perinatal Outcomes in Pregnancies With Type 1 Diabetes and Controls During a 15-Year Period (2006-2020).Mayo Clinic proceedings. Innovations, quality & outcomes · 2025Article
- Exposure to Low-Level Air Pollution and Hyperglycemia Markers during Pregnancy: A Repeated Measure Analysis.Environmental science & technology · 2024Article
- Glycemic Variability in Type 1 Diabetes Mellitus Pregnancies-Novel Parameters in Predicting Large-for-Gestational-Age Neonates: A Prospective Cohort Study.Biomedicines · 2022Article
- Programming of cardiometabolic health: the role of maternal and fetal hyperinsulinaemia.The Journal of endocrinology · 2022Review
- Offspring birthweight and placental weight-does the type of maternal diabetes matter? A population-based study of 319 076 pregnancies.Acta obstetricia et gynecologica Scandinavica · 2021Article
- Potentially modifiable risk factors of preterm delivery in women with type 1 and type 2 diabetes.Diabetologia · 2021Article
- Maternal-foetal complications in pregnancy: a retrospective comparison between type 1 and type 2 diabetes mellitus.BMC pregnancy and childbirth · 2021Article
- Novel Biochemical Markers of Glycemia to Predict Pregnancy Outcomes in Women With Type 1 Diabetes.Diabetes care · 2021Article
- Application of CEEMD noise reduction algorithm in ultrasound imaging in evaluating fetuses with abnormal glucose metabolism in late pregnancy.Pakistan journal of medical sciences · 2021Article
- Maternal overweight is not an independent risk factor for increased birth weight, leptin and insulin in newborns of gestational diabetic women: observations from the prospective 'EaCH' cohort study.BMC pregnancy and childbirth · 2018Observational
- Biomarkers for Macrosomia Prediction in Pregnancies Affected by Diabetes.Frontiers in endocrinology · 2018Review
- Article
- Review
- Is There a Role for HbA1c in Pregnancy?Current diabetes reports · 2016Review
- The Association Between Diabetes Mellitus Among American Indian/Alaska Native Populations with Preterm Birth in Eight US States from 2004-2011.Maternal and child health journal · 2015Article
- Application of glycated hemoglobin in the perinatal period.International journal of clinical and experimental medicine · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo analyse data from a randomised, controlled study of prandial insulin aspart versus human insulin, both with NPH insulin, in pregnant women with type 1 diabetes for potential factors predicting poor pregnancy outcomes. RESEARCH DESIGN/
methodPost hoc analysis including 91 subjects randomised prior to pregnancy with known outcome in early pregnancy and 259 subjects randomised prior to pregnancy/during pregnancy of <10 weeks' gestation with known late-pregnancy outcomes. Poor early-pregnancy outcomes included fetal loss <22 gestational weeks and/or congenital malformation (n=18). Poor late-pregnancy outcomes included: composite endpoint including pre-eclampsia, preterm delivery and perinatal death (n=78); preterm delivery (n=63); and excessive fetal growth (n=88).
results18 patients experienced a malformed/lost fetus in early pregnancy - none preceded by severe hypoglycaemia. Albuminuria in early pregnancy was a significant predictor of poor late-pregnancy outcome (composite endpoint; p=0.012). In the third trimester, elevated HbA1c, ≥ 1 plasma glucose (PG) measurement >11 mmol/L (198 mg/dL) and %PG values outside 3.9-7.0 mmol/L (70-126 mg/dL) were significant predictors of poor late-pregnancy outcomes (all p<0.05).
conclusionsElevated HbA1c, high glucose spikes and out-of-range %PG in the third trimester, and albuminuria in early pregnancy, are associated with poor late-pregnancy outcomes.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.