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
A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes.
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 NCT00474045 (A Randomised, Parallel-group, Open-labelled, Multinational Trial Comparing the Efficacy and Safety of Insulin Detemir), which is not on this map. Cited by 35 papers, 4 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-labelled, Multinational Trial Comparing the Efficacy and Safety of Insulin Detemir (Levemir®) Versus Human Insulin (NPH Insulin), Used in Combination With Insulin Aspart as Bolus Insulin, in the Treatment of Pregnant Women With Type 1 Diabetes
Who cites it
35 citing papers in PubMed, 4 syntheses or guidelines pooled it, 98 citations in OpenAlex.
- A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study.BJOG : an international journal of obstetrics and gynaecology · 2021Pooled it
- Effectiveness of Insulin Analogs Compared with Human Insulins in Pregnant Women with Diabetes Mellitus: Systematic Review and Meta-analysis.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2019Pooled it
- Treatments for women with gestational diabetes mellitus: an overview of Cochrane systematic reviews.The Cochrane database of systematic reviews · 2018Pooled it
- Different insulin types and regimens for pregnant women with pre-existing diabetes.The Cochrane database of systematic reviews · 2017Pooled it
- Comparing the efficacy and safety of insulin detemir versus neutral protamine hagedorn insulin in treatment of diabetes during pregnancy: a randomized, controlled study.BMJ open diabetes research & care · 2020Trial
- Insulin glargine 300 U/mL safety data in pregnancy.Diabetes, obesity & metabolism · 2025Article
- Insulin Use During Gestational and Pre-existing Diabetes in Pregnancy: A Systematic Review of Study Design.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024Review
- 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes-2024.Diabetes care · 2024Review
- Comparison of treatment with insulin detemir and NPH in women with gestational diabetes mellitus: glycemic control and pregnancy outcomes. A retrospective study.Hormones (Athens, Greece) · 2023Article
- 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes-2023.Diabetes care · 2023Review
- [Clinical practice recommendations for diabetes in pregnancy (Update 2023)].Wiener klinische Wochenschrift · 2023Article
- Maternal and neonatal outcomes with the use of long acting, compared to intermediate acting basal insulin (NPH) for managing diabetes during pregnancy: a systematic review and meta-analysis.Diabetology & metabolic syndrome · 2022Review
- Gestational Diabetes Mellitus-Recent Literature Review.Journal of clinical medicine · 2022Review
- Proteomic Changes to the Updated Discovery of Engineered Insulin and Its Analogs: Pros and Cons.Current issues in molecular biology · 2022Review
- Article
- Is Glycated Hemoglobin A1c Level Associated with Adverse Pregnancy Outcomes of Women Affected by Pre-Gestational Diabetes?Medicina (Kaunas, Lithuania) · 2021Observational
- Different Gestational Diabetes Phenotypes: Which Insulin Regimen Fits Better?Frontiers in endocrinology · 2021Article
- Developing a core outcome set for the treatment of pregnant women with pregestational diabetes-a study protocol.Trials · 2020Article
- Effect of Different Insulin Therapies on Obstetric-Fetal Outcomes.Scientific reports · 2019Article
- Improving pregnancy outcomes in women with diabetes mellitus: modern management.Nature reviews. Endocrinology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented.
methodsSubjects were randomized to IDet (n = 152) or NPH (n = 158) ≤12 months before pregnancy or at 8-12 gestational weeks.
resultsFor IDet and NPH, there were 128 and 136 live births, 11 and 9 early fetal losses, and two and one perinatal deaths, respectively. Gestational age at delivery was greater for children from the IDet arm than the NPH arm (treatment difference: 0.49 weeks [95% CI 0.11;0.88], p = 0.012, linear regression). Sixteen children had a malformation (IDet: n = 8/142, 5.6%; NPH: n = 8/145, 5.5%). The incidence of adverse events was similar between treatments.
conclusionIDet is as well tolerated as NPH as regards perinatal outcomes in pregnant women with type 1 diabetes and no safety issues were identified.
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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.