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Timing of Delivery in Women with Pre-Pregnancy Diabetes Mellitus: A

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Timing of Delivery in Women with Pre-Pregnancy Diabetes Mellitus: A Epidemiology/Health Services Research BMJ Open Diab Res Care: first published as 10.1136/bmjdrc-2019-000758 on 30 December 2019. Downloaded from Open access Original research Timing of delivery in women with pre- pregnancy diabetes mellitus: a population- based study Meghan Brown,1 Nir Melamed,2 Beth Murray- Davis,3 Haroon Hassan,4 Karizma Mawjee,5 Jon Barrett,2 Sarah D McDonald,6 Joel G Ray,7 Michael Geary,8 Howard Berger 5 To cite: Brown M, Melamed N, ABSTRACT Murray- Davis B, et al. Timing of Objectives Controversy exists about the timing of delivery Significance of this study delivery in women with pre- of women with pre-pregnanc y type 1 and 2 diabetes pregnancy diabetes mellitus: mellitus (PDM). This study aims to compare maternal and What is already known about this subject? a population- based study. neonatal outcomes after induction of labor (IOL) at 38 ► Pregnancies complicated by pre-pregnanc y type 1 BMJ Open Diab Res Care weeks’ gestation versus expectant management from 39 and 2 diabetes mellitus (PDM) are at increased risk 2019;7:e000758. doi:10.1136/ of adverse perinatal outcomes. bmjdrc-2019-000758 weeks onward. Research design and methods This was a retrospective ► While induction of labor before 40 weeks’ gestation population- based cohort study using data from the can potentially reduce the rate of certain adverse ► Additional material is Better Outcomes Registry and Network in Ontario prenatal outcomes, early delivery is also associated published online only. To view Canada. Included were all women with PDM, who had a with an increase in neonatal complications. please visit the journal online 0/7 singleton hospital birth at ≥38 weeks’ gestation from What are the new findings? (http:// dx. doi. org/ 10. 1136/ 2012 to 2017. Maternal and perinatal outcomes were bmjdrc- 2019- 000758). ► In women with PDM, induction of labor between compared between 937 pregnancies that underwent 380/7 and 386/7 was not associated with an increased IOL at 380/7–386/7 weeks (‘38- IOL group’) versus 1276 cesarean section rate compared with expectant Received 17 July 2019 pregnancies expectantly managed resulting in a birth at 0/7 management beyond 39 weeks. Revised 31 October 2019 ≥39 weeks (‘39- Exp group’). The primary outcome was ► In women with PDM, induction of labor between Accepted 25 November 2019 all- cause cesarean delivery. Multivariable modified Poisson 380/7 and 386/7 was associated with an increased regression was performed to generate adjusted relative rate of neonatal intensive care admission, jaundice risks (aRR) and 95% CIs, adjusted for parity, maternal and hypoglycemia compared with expectant man- age, pre- pregnancy body mass index and PDM type. agement beyond 39 weeks. Other outcomes included instrumental delivery, neonatal intensive care unit (NICU) admission, and newborn How might these results change the focus of metabolic disturbances. research or clinical practice? Results Cesarean delivery occurred in 269 women http://drc.bmj.com/ ► This study provides additional evidence regarding (28.7%) in the 38- IOL group versus 333 women (26.1%) timing of delivery in women with PDM that can be in the 39- Exp group—aRR 1.07 (95% CI 0.94 to 1.22). The used in formulating clinical practice guidelines and respective rates of instrumental delivery were 11.2% and as the basis for future prospective randomized trials. 10.2% (aRR 1.25, 95% CI 0.98 to 1.61). NICU admission was more common in the 38- IOL group (27.6%) than in the 39- Exp group (16.8%) (aRR 1.61, 95% CI 1.36 to 1 2 and newborn. Despite improved glycemic on October 1, 2021 by guest. Protected copyright. 1.90), as were jaundice requiring phototherapy (12.4% control, and a declining rate of some vs 6.2%) (aRR 1.93, 95% CI 1.46 to 2.57) and newborn 2 3 hypoglycemia (27.3% vs 14.7%) (aRR 1.74, 95% CI 1.46 congenital anomalies, perinatal mortality, to 2.07). preterm birth, large for gestational age Conclusion In pregnant women with PDM, IOL at (LGA) birth weight, shoulder dystocia and 380/7–386/7 weeks was not associated with a higher risk of stillbirth remain high.4 Furthermore, women © Author(s) (or their cesarean delivery, compared with expectant management, with PDM experience higher rates of pre- employer(s)) 2019. Re- use but was associated with a higher risk of certain adverse eclampsia, and are more likely to deliver by permitted under CC BY-NC. No neonatal outcomes. commercial re- use. See rights cesarean section (CS), compared with women 3 5 6 and permissions. Published without PDM. by BMJ. Induction of labor (IOL) at 38–40 weeks’ For numbered affiliations see INTRODUCTION gestation has been endorsed as a part of end of article. Pre- pregnancy diabetes mellitus (PDM)— the management of a pregnancy affected Correspondence to type 1 or type 2 DM preceding concep- by PDM to prevent stillbirth, and to Dr Howard Berger; tion—is increasing in prevalence, with decrease macrosomia- related complications howard. berger@ unityhealth. to important adverse outcomes for mother such as shoulder dystocia, anal sphincter BMJ Open Diab Res Care 2019;7:e000758. doi:10.1136/bmjdrc-2019-000758 1 BMJ Open Diab Res Care: first published as 10.1136/bmjdrc-2019-000758 on 30 December 2019. Downloaded from Epidemiology/Health Services Research injuries, birth trauma, and possibly, the need for cesarean regular data validation, quality checks, and training for delivery.7–10 Routine IOL may also avoid the development individuals entering and using the data to support a high of maternal complications, such as pre- eclampsia, which level of data quality (http://www. bornontario. ca/ en/ is more common in a pregnancy complicated by PDM.6 data/). However, routine IOL prior to 39 weeks’ gestation may The DAD contains a set of validated diagnostic codes place a neonate at higher risk of complications related from the International Statistical Classification of Diseases to early term delivery, and may also increase the rate of and Related Health Problems, 10th Revision, Canadian CS,11–13 although the latter notion has been recently chal- version, as well as intervention codes from the Canadian lenged by data from studies in non-PDM populations.14–16 Classifications of Health Intervention for all in- hospital Data to support the optimal timing for IOL for women deliveries. The linkage between the BIS and the DAD was with PDM are lacking. Expert guidelines supporting done to ensure the highest degree of capture of maternal routine IOL are based on small studies, and extrap- conditions preceding pregnancy, including PDM, and olated from outcome data in pregnancies compli- neonatal outcomes occurring in the NICU, which may cated by both gestational diabetes mellitus (GDM) and not be fully detailed within the BIS. All diagnostic and PDM.7 17 18 Recently published data suggest that, in procedural codes, along with definitions used to identify women with GDM, routine IOL at 38 or 39 weeks is asso- the cohort, characteristics, exposure and outcome vari- ciated with a lower risk of cesarean delivery compared ables are listed in online supplementary appendix S1. with expectant management but has a higher rate of neonatal intensive care unit (NICU) admission.19 Studies Study population that specifically address the timing of IOL for women The study population comprised all singleton pregnan- with diabetes focused on women with GDM,20–23 which cies with PDM who were undelivered at ≥380/7 weeks’ may not be generalizable to women with PDM, who have gestation between 1 April 2012 and 31 March 2017. a higher risk of complications.24 PDM was defined as a pre-pregnancy diagnosis of type The aim of the current study was to compare maternal 1 or type 2 diabetes.27 To create a low- risk obstetric and neonatal outcomes in women with PDM induced cohort of women with PDM, who would be eligible for at 380/7–386/7 weeks’ gestation versus women with PDM a vaginal birth, women with the following conditions expectantly managed, and who remained undelivered at were excluded: gestational age at birth ≥420/7 weeks, 390/7 weeks’ gestation. non- vertex presentation, placenta previa, previous CS, major fetal anomaly, chronic hypertension, chronic renal disease, complications of diabetes (eg, retinopathy, renal RESEARCH DESIGN AND METHODS dysfunction), congenital or acquired cardiac disease, Study setting pulmonary hypertension, cystic fibrosis, pulmonary This population- based cohort study included all women embolism, systemic lupus erythematosus, hemophilia or with PDM in the province of Ontario, Canada. Ontario sickle cell disease. Women with PDM who were diagnosed is the most populous province in Canada with a popu- with gestational hypertension or pre-eclampsia before lation of 14 million people25 and all residents receive 380/7 weeks were also excluded. A pragmatic decision universal health coverage under the government-funded was made to include only women who delivered after 38 http://drc.bmj.com/ provincial health insurance plan (OHIP: Ontario Health weeks of gestation since in our population, women would Insurance Plan). During the study period there were not be routinely induced prior to 38 weeks of gestation no national or provincial guidelines dictating timing of without an additional cause or comorbid state. delivery in women with PDM, only broad suggested IOL guidelines from international societies.8 9 26 Exposure The cohort was divided into two exposure groups, on October 1, 2021 by guest. Protected copyright. Data sources to mimic the real- life dilemma faced by a healthcare Data were obtained from the Better Outcomes Registry provider: whether to induce at 38 weeks’ gestation or and Network Information System (BIS) (http://www. expectantly manage until at least 390/7 weeks.
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