scholarly journals Protocol for development and validation of a clinical prediction model for adverse pregnancy outcomes in women with gestational diabetes

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e038845
Author(s):  
Shamil D. Cooray ◽  
Jacqueline A. Boyle ◽  
Georgia Soldatos ◽  
Javier Zamora ◽  
Borja M. Fernández Félix ◽  
...  

IntroductionGestational diabetes (GDM) is a common yet highly heterogeneous condition. The ability to calculate the absolute risk of adverse pregnancy outcomes for an individual woman with GDM would allow preventative and therapeutic interventions to be delivered to women at high-risk, sparing women at low-risk from unnecessary care. The Prediction for Risk-Stratified care for women with GDM (PeRSonal GDM) study will develop, validate and evaluate the clinical utility of a prediction model for adverse pregnancy outcomes in women with GDM.Methods and analysisWe undertook formative research to conceptualise and design the prediction model. Informed by these findings, we will conduct a model development and validation study using a retrospective cohort design with participant data collected as part of routine clinical care across three hospitals. The study will include all pregnancies resulting in births from 1 July 2017 to 31 December 2018 coded for a diagnosis of GDM (estimated sample size 2430 pregnancies). We will use a temporal split-sample development and validation strategy. A multivariable logistic regression model will be fitted. The performance of this model will be assessed, and the validated model will also be evaluated using decision curve analysis. Finally, we will explore modes of model presentation suited to clinical use, including electronic risk calculators.Ethics and disseminationThis study was approved by the Human Research Ethics Committee of Monash Health (RES-19–0000713 L). We will disseminate results via presentations at scientific meetings and publication in peer-reviewed journals.Trial registration detailsSystematic review proceeding this work was registered on PROSPERO (CRD42019115223) and the study was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12620000915954); Pre-results.

Author(s):  
Shamil D. Cooray ◽  
Jacqueline A. Boyle ◽  
Georgia Soldatos ◽  
Shakila Thangaratinam ◽  
Helena J. Teede

AbstractGestational diabetes mellitus (GDM) is common and is associated with an increased risk of adverse pregnancy outcomes. However, the prevailing one-size-fits-all approach that treats all women with GDM as having equivalent risk needs revision, given the clinical heterogeneity of GDM, the limitations of a population-based approach to risk, and the need to move beyond a glucocentric focus to address other intersecting risk factors. To address these challenges, we propose using a clinical prediction model for adverse pregnancy outcomes to guide risk-stratified approaches to treatment tailored to the individual needs of women with GDM. This will allow preventative and therapeutic interventions to be delivered to those who will maximally benefit, sparing expense, and harm for those at a lower risk.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eman M Alfadhli

Abstract Background Maternal obesity and gestational diabetes (GDM) are commonly encountered during pregnancy. Both conditions are independently associated with unfavorable pregnancy consequences. The objective of this study was to compare the effects of obesity and GDM on birth weight, macrosomia, and other adverse pregnancy outcomes. Methods This cohort study involved 531 women with a singleton pregnancy attending the Maternity and Children’s Hospital, Medina, Saudi Arabia, between June 2014 and June 2015. Participants underwent a 75-g oral glucose tolerance test between 24 and 28 weeks. The International Association of Diabetes and Pregnancy Study Groups criteria were used for GDM diagnosis. BMI was assessed at the first antenatal visit, and obesity was defined as a BMI ≥30.0 kg/m2. All women were followed up until delivery. Women were divided into 4 groups: non-GDM nonobese (reference group), GDM nonobese, obese non-GDM, and obese GDM. Clinical characteristics and adverse pregnancy outcomes were compared. Results The mean age and BMI of the participants were 30.5 years and 29.3 kg/m2, respectively. GDM was diagnosed in 50.2% of the participants, and obesity was diagnosed in 47.8% of the participants. Obese women with GDM were the oldest and heaviest among all women. The mean birth weight increased in order among the four groups; it was highest in the infants in the obese GDM group, followed by those in the obese non-GDM, GDM nonobese and reference groups. Obesity and GDM alone or in combination were associated with higher rates of macrosomia and cesarean deliveries than the reference group. Neonatal intensive care unit (NICU) admission was higher in infants in the GDM nonobese and obese GDM groups. The frequency of low Apgar score was significantly higher in infants in the obese GDM group than in infants in the reference group. Conclusions Maternal obesity seems to influence birth weight more than GDM, while GDM is associated with a greater risk of admission to the NICU. The combination of both conditions is associated with the greatest risk of adverse pregnancy outcomes.


2020 ◽  
Vol 9 (9) ◽  
pp. 2732
Author(s):  
Ellen Deleus ◽  
Bart Van der Schueren ◽  
Roland Devlieger ◽  
Matthias Lannoo ◽  
Katrien Benhalima

Background: Pregnancies in women with a history of bariatric surgery are becoming increasingly prevalent. Surgically induced metabolic changes benefit mother and child, but can also lead to some adverse pregnancy outcomes. Knowledge about glucose homeostasis in these pregnancies could elucidate some of the mechanisms behind these outcomes. This review focusses on glucose homeostasis and birth weight. Methods: We considered papers dealing with glucose homeostasis, gestational diabetes mellitus (GDM) and/or small-for-gestational age infants (SGA) in pregnancies with a history of sleeve gastrectomy (SG) or Roux-en-y gastric bypass (RYGB). Results: Since an OGTT is unreliable to diagnose GDM in a pregnancy after bariatric surgery, the true incidence of GDM is unknown. Alternative screening strategies are needed. Furthermore, these pregnancies are marked by frequent hypoglycemic events as well as wide and rapid glycemic excursions, an issue that is very likely underreported. There is a lack of uniformity in reporting key outcomes and a large variation in study design and control population. Conclusion: Alteration of glucose homeostasis in a pregnancy after bariatric surgery should be further studied using unequivocal definition of key concepts. Glycemic control may prove to be a modifiable risk factor for adverse pregnancy outcomes such as the delivery of an SGA baby.


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