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Technology and Pregnancy

2018; Mary Ann Liebert, Inc.; Volume: 20; Issue: S1 Linguagem: Inglês

10.1089/dia.2018.2508

1557-8593

Jennifer M. Yamamoto, Helen Murphy,

Pregnancy and preeclampsia studies

Diabetes Technology & TherapeuticsVol. 20, No. S1 Original ArticlesFree AccessTechnology and PregnancyJennifer M. Yamamoto and Helen R. MurphyJennifer M. YamamotoDepartment of Medicine, University of Calgary, Calgary, Alberta, CanadaSearch for more papers by this author and Helen R. MurphyCambridge University Hospitals National Health Service Foundation Trust, Cambridge, United Kingdom.Women’s Health Academic Centre, Division of Women’s and Children’s Health, King’s College London, London, United Kingdom.Norwich Medical School, University of East Anglia, Norwich, United Kingdom.Search for more papers by this authorPublished Online:1 Feb 2018https://doi.org/10.1089/dia.2018.2508AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail IntroductionThe 10 manuscripts chosen for this year's article reflect some key advances in the field of diabetes pregnancy, with large-scale national and international collaborations pulling together to establish an evidence base for improving the health outcomes of pregnant women with diabetes and their children. A major advance in the management of pregestational diabetes has been to collect and publish contemporary pregnancy outcome data in a timely fashion. The United Kingdom's National Pregnancy in Diabetes (NPID) audit has published maternal characteristics and obstetric and neonatal outcome data on over 3000 pregnancies (1). This large sample size allows for statistical comparison of serious adverse events and documents a sustained 2.5-fold reduction in the rate of stillbirth for pregnant women with both type 1 and type 2 diabetes. While there is a small decline in stillbirth in the general maternity population, the reduction in diabetes pregnancy is substantial and is most likely related to improvements in pregnancy preparation, fetal surveillance, and earlier delivery. Unfortunately, there are no changes in rates of congenital anomaly or neonatal death. The audit also highlights suboptimal glucose control in type 1 diabetes and unacceptable clinic to clinic variation in the care of pregnant women with type 1 and type 2 diabetes. The expectation is that by publishing these data there will be more collaborative work to ensure that services that are currently struggling are supported to improve. The audit highlights the need for new technologies to improve glucose control in late gestation type 1 diabetes pregnancy. The first automated insulin delivery, overnight closed-loop, in a pregnancy trial reported a 15% increase in overnight time in target compared with the best available comparator of sensor-augmented pump therapy (2). The lived experiences of women with diabetes who used closed-loop technology are reported separately and serve to remind us that as with all new treatments there are both benefits and burdens to be considered (3). Not surprisingly individuals weigh these up differently, as some women with biomedical improvements were quite ambivalent about closed-loop, while others with minimal objective improvement were far more positive about the impact of closed-loop on quality of life and reduced burden of diabetes self-management. Longer-duration randomized trials comparing closed-loop and usual care with detailed biomedical and psychosocial outcomes are now required. Law et al. urge us to look beyond traditional markers of glucose control like glycated hemoglobin (HbA1c) and estimated average glucose (eAG). A novel pregnancy-specific estimated average glucose (PeAG) is proposed, with the suggestion of aiming for a PeAG of 6.4–6.7 mmol/mol (4). Abell and colleagues remind us not to assume that increasing use of technology is necessarily associated with improved pregnancy outcomes and recommend larger-scale, high-quality trials of insulin pumps in pregnancy (5). The diabetes pregnancy community need to consider whether this is still feasible given the widespread use of pumps before and during pregnancy and/or whether trials of automated insulin delivery are more relevant.A landmark collaboration from the International Weight Management in Pregnancy (i-WIP) Collaborative Group provides the first individual patient data meta-analyses of diet and exercise interventions to reduce obstetric and neonatal risks in obese pregnant women (6). These data confirm that dietary and physical activity interventions are not harmful and work for women of all weights. Even modest weight loss, approximately 0.7 kg, is associated with reduced risk of caesarean delivery. Interventions based on increased physical activity may be particularly effective for reducing risk of gestational diabetes (GDM). Hodson et al. suggest that in women with GDM, greater weight loss (0.4 kg per week) can be safely achieved with a hypo-energetic diet of 1200 kcal/day, with 50% reduced liver triacylglycerol and reduced need for additional insulin and/or metformin (7). As uncertainty remains about the use of glyburide and to a lesser extent metformin (8), a stronger evidence base for more rigorous, well-described dietary interventions in GDM is required and likewise for antenatal breastmilk expressing, which seems intuitively sensible for management of neonatal hypoglycemia (9). While this does not seem to cause harm, larger trials of higher-risk women are needed before this can be routinely recommended for all women with diabetes. Finally, a French group have reported the potential for good pregnancy outcomes in women with cystic fibrosis (CF). Furthermore, with improved treatment protocols, cystic fibrosis–related diabetes (CFRD) was not associated with decline in lung function or maternal nutritional status after pregnancy (10).Key Articles Reviewed for the ArticleImproved pregnancy outcomes in women with type 1 and type 2 diabetes but substantial clinic-to-clinic variations: a prospective nationwide studyMurphy HR, Bell R, Cartwright C, Curnow P, Maresh M, Morgan M, Sylvester C, Young B, Lewis-Barned NDiabetologia 2017;60: 1668–1677Closed-loop insulin delivery during pregnancy in women with type 1 diabetesStewart ZA, Wilinska ME, Hartnell S, Temple RC, Rayman G, Stanley KP, Simmons D, Law GR, Scott EM, Hovorka R, Murphy HRN Engl J Med 2016;375: 644–654Experiences of closed-loop insulin delivery among pregnant women with type 1 diabetesFarrington C, Stewart ZA, Barnard K, Hovorka R, Murphy HRDiabet Med 2017;34: 1461–1469Translating HbA1c measurements into estimated average glucose values in pregnant women with diabetesLaw GR, Gilthorpe MS, Secher AL, Temple R, Bilous R, Mathiesen ER, Murphy HR, Scott EMDiabetologia 2017;60: 618–624Pregnancy outcomes and insulin requirements in women with type 1 diabetes treated with continuous subcutaneous insulin infusion and multiple daily injections: cohort studyAbell SK, Suen M, Pease A, Boyle JA, Soldatos G, Regan J, Wallace EM, Teede HJDiabetes Technol Ther 2017;19: 280–287Effect of diet and physical activity based interventions in pregnancy on gestational weight gain and pregnancy outcomes: meta-analysis of individual participant data from randomised trialsInternational Weight Management in Pregnancy (i-WIP) Collaborative GroupBMJ 2017;358: j3119Liver triacylglycerol content and gestational diabetes: effects ofmoderate energy restrictionHodson K, Dalla Man C, Smith FE, Barnes A, McParlin C, Cobelli C, Robson SC, Araújo-Soares V, Taylor RDiabetologia 2017;60: 306–313Glyburide versus metformin and their combination for the treatment of gestational diabetes mellitus: a randomized controlled studyNachum Z, Zafran N, Salim R, Hissin N, Hasanein J, Gam Ze Letova Y, Suleiman A, Yefet EDiabetes Care 2017;40: 332–337Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trialForster DA, Moorhead AM, Jacobs SE, Davis PG, Walker SP, McEgan KM, Opie GF, Donath SM, Gold L, McNamara C, Aylward A, East C, Ford R, Amir LHLancet 2017;389: 2204–2213Pregnancy outcome in women with cystic fibrosis-related diabetesReynaud Q, Poupon-Bourdy S, Rabilloud M, Al Mufti L, Rousset Jablonski C, Lemonnier L, Nove-Josserand R, Touzet S, Durieu I; and participating centers of the French Cystic Fibrosis RegistryActa Obstet Gynecol Scand 2017;96: 1223–1227Improved pregnancy outcomes in women with type 1 and type 2 diabetes but substantial clinic-to-clinic variations: a prospective nationwide studyMurphy HR1,2, Bell R3, Cartwright C4, Curnow P4, Maresh M5, Morgan M6, Sylvester C4, Young B4, Lewis-Barned N71Norwich Medical School, University of East Anglia, Norwich, UK2Division of Women's Health, North Wing, St. Thomas' Campus, Kings College London, London, UK3Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK4Clinical Audits & Registries Management Service, NHS Digital, Leeds, UK5Department of Obstetrics, St. Mary's Hospital, Central Manchester University Hospital NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK6Department of Obstetrics, Singleton Hospital, Abertawe Bro Morgannwg, Swansea, UK7Department of Diabetes and Endocrinology, Northumbria Healthcare NHS Foundation Trust, Northumberland, UKDiabetologia 2017;60: 1668–1677ObjectivesThis prospective nationwide study examined outcomes of pregnant women with pregestational diabetes in England and Wales and compared changes over the decade since the 2002–2003 Confidential Enquiry in Maternal and Child Health.MethodsData were collected as part of a national audit whereby maternity clinics are required to complete web-based data entry forms for all pregnant women with diabetes who had a pregnancy that ended in 2015. Outcomes of interest such as pregnancy preparation (5 mg folic acid, first trimester HbA1c); perinatal morbidity (delivery prior to 37 weeks, large-for-gestational-age infants); congenital anomaly; stillbirth; and neonatal death were collected and analyzed.ResultsA total of 3036 women from 155 maternity clinics were included. Most women had type 1 diabetes (51%) or type 2 diabetes (46%), with other types of diabetes comprising 3% of women. The level of glycemic control (HbA1c <6.5% or 48 mmol/mol) achieved by women differed by clinic attended (median for women with type 1 diabetes 14.3% [interquartile range 7.7–22.2], type 2 diabetes 37.0% [27.3–46.2]). In comparison with women with type 2 diabetes, women with type 1 diabetes had more preterm births (39.7% vs. 21.7%, P<0.001) and more large-for-gestational-age infants (46.4% vs. 23.9%, P 12,500 women in 16 countries. This included 22 studies from Europe; 4 each from the United States, Australia, and Brazil; and 1 each from Egypt and Iran. In 23 studies women of any weight were included, while 6 studies included overweight and obese women and 7 included only obese women. The interventions were mainly based on diet (n=4), PA (n=16), or a combination of diet and lifestyle (n=15). Women with gestational diabetes (GDM) and known hypertensive disorders were excluded. The primary outcome was gestational weight gain (GWG), defined as the difference between maternal weight at booking and the last weight before delivery. Key secondary outcomes were GDM, hypertensive disorders, preterm and caesarean delivery (mothers) and stillbirth, large or small for gestational age, and neonatal intensive care unit (NICU) admission (infants). The overall effects of interventions were examined for composite and for individual maternal and infant outcomes.ResultsThe women were mostly (>80%) white, 45% primiparous, 40% obese, and 40% sedentary. Approximately 50% were classified as having high socioeconomic status. Data for approximately 50% of eligible women was not available. The largest data sets were available for gestational age (34 studies, >12,000 women), with similarly high numbers (<11,000) for preterm delivery, and small numbers for gestational age (SGA) and caesarean section. For GWG, hypertensive disorders of pregnancy, and GDM there were data from approximately 9500 women. Slightly smaller data sets were available for the maternal and infant composite outcomes (8800 and 7900 respectively). Both diet and PA interventions were effective in reducing GWG by approximately 0.7 kg, which did not differ according to maternal normal weight, overweight, or obesity. Likewise, there was no evidence of differential effects for maternal baseline demographic characteristics such as age, parity, ethnicity, and preexisting medical conditions. There was also a significant reduction in caesarean section, with summary estimates that favored the interventions for both the maternal and infant composite outcomes, but these did not reach statistical significance. The reduction in other individual outcomes such as GDM and preterm delivery were also not statistically significant. When study-level data from non-IPD studies were meta-analyzed with IPD, there was stronger evidence for GDM reduction (59 studies in 16,885 women). Interventions based on PA showed a reduction in GDM in both IPD and combined IPD and non-IPD meta-analysis (OR 0.67 and 0.66 respectively). Likewise, for the impact of PA on reduction in caesarean section and hypertensive disorders, the combined IPD and non-IPD meta-analysis suggested stronger evidence of benefit with reductions by 17% for caesarean section and 32% for hypertensive disorders. For diet-only interventions there was a strong effect for reduction in preterm delivery in both the IPD alone and the combined IPD and non-IPD meta-analysis, but these analyses were limited to 4 and 7 studies with approximately 1300 and 1700 women respectively.ConclusionsThis large collaborative IPD meta-analysis confirms that diet and PA interventions are effective for reducing GWG in all women and did not vary according to maternal weight. However, the effect is clinically modest (0.7 kg), and impact on postpartum weight retention and longer-term health outcomes is unknown. The only individual outcome impacted was reduced odds of delivery by caesarean section. The addition of study level data from non-IPD studies showed benefit for reduction in GDM, in particular for PA-based interventions. The lack of harm (for example, no increase in preterm delivery or small for gestational age) should provide reassurance to mothers and clinicians that diet and PA are safe during pregnancy.CommentsThis large collaborative undertaking is the first to evaluate the differential effects of diet and PA on a range of clinically important outcomes. This provided statistical power for estimating covariate interactions and adjusting for maternal age, weight, and important baseline characteristics. Because of the speed of new publications in this area, it was not possible to perform IPD meta-analysis for all published trials. They therefore also reported on outcomes from combined IPD and non-IPD