Desfechos materno-fetais de gestantes com diabetes mellitus tipo 1 em tratamento com sistema de infusão contínua versus múltiplas doses de insulina durante a gravidez: estudo de coorte retrospectiva
Date
2022
Authors
Ogassavara, Juliana [UNIFESP]
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Almeida-Pititto, Bianca de [UNIFESP]
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Dissertação de mestrado
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Abstract
Introdução: Gestantes com diabetes tipo 1 (DM1) apresentam maior risco de complicações materno-fetais. Em relação ao tratamento, o sistema de infusão contínua de insulina (SICI) apresenta vantagens em relação às múltiplas doses de insulina (MDI), mas dados sobre a melhor opção durante a gravidez são limitados. Objetivos: Comparar os desfechos materno-fetais de gestantes com DM1 em uso de SICI ou MDI durante a gravidez. Métodos: O estudo incluiu a avaliação de 174 gestações de mulheres com DM1 em acompanhamento de janeiro/2008 a dezembro/2021. Os dados foram coletados durante o acompanhamento das participantes e registrados em um banco de dados. As variáveis de interesse foram comparadas entre os grupos (SICI versus MDI) e foi realizada análise de regressão logística, p<0,05. Resultados: Das 174 gestações avaliadas, 21,3%(37) utilizaram SICI e 78,7%(137) MDI, com média de idade de 26,7(5,4) anos. Perfil lipídico, presença de hipertensão crônica, IMC pré-gestacional e ganho de peso foram semelhantes nos dois grupos, enquanto o hipotireoidismo foi mais prevalente nas usuárias de SICI [32,4 vs. 17,5%, p=0,047] do que nas usuárias de MDI. Houve melhora na HbA1c ao longo da gestação em ambos os grupos, mas não houve diferença nos valores de HbA1c no primeiro trimestre [8,3(1,7) vs. 8,8(1,8)%, p=0,122] e no 3º trimestre de gravidez [6,9 (0,8) vs. 7,1(1,0)%, p=0,611] comparando SICI vs. MDI, respectivamente. A frequência de parto cesáreo foi significativamente maior no grupo SICI [94,1 vs. 75,4%, p=0,017], mas não houve diferença estatística na frequência de outras complicações, como abortamento espontâneo, parto prematuro e pré-eclâmpsia, bem como na média de peso ao nascer e ocorrência de complicações neonatais, como óbito perinatal, hiperbilirrubinemia, desconforto respiratório, hipoglicemia e internação em UTIN, exceto pela proporção de malformações congênitas que foi significativamente menor no grupo SICI [2,9 vs. 15,6%, p=0,048]. Na análise de regressão, a associação de SICI com parto cesáreo e com malformações perdeu significância após ajustes para HbA1c no primeiro modelo ajustado e persistiu não significativa após ajustes para outras covariáveis de interesse. Conclusões: Neste estudo, o uso de SICI foi associado a uma maior frequência de parto cesáreo e a uma menor ocorrência de malformações congênitas. A associação do uso de SICI com estes desfechos perdeu a significância estatística após ajustes para potenciais confundidores. A maior taxa de parto cesáreo pode ter sido associada a casos mais graves de DM, uma vez que essas pacientes apresentavam maior duração do DM e o perfil de usuárias de bomba de insulina no Brasil costuma ser mais desafiador. As menores frequências de malformações no grupo SICI podem ter sido mediadas pelo controle glicêmico durante o início da gravidez, já que, embora não tenha havido diferença nos valores de HbA1c quando comparados ao grupo MDI, observamos uma tendência a um pior controle de HbA1c durante a gestação nas mulheres que tiveram malformação nos seus filhos em comparação àquelas que não tiveram. A avaliação de outros parâmetros de controle glicêmico, como a variabilidade glicêmica e tempo no alvo, pode auxiliar a esclarecer essa hipótese em pesquisas futuras sobre a comparação dos tratamentos com SICI e MDI durante a gravidez em pacientes com DM1. Não houve diferença nos demais desfechos materno-fetais entre os dois grupos.
Introduction: Pregnant women with type 1 diabetes (T1D) have an increased risk of maternal-fetal complications. Regarding treatment, continuous subcutaneous insulin infusion (CSII) has advantages compared to multiple daily injections (MDI), but data about the best option during pregnancy is limited. Objectives: To compare maternal-fetal outcomes of pregnant women with T1D using CSII or MDI during pregnancy. Methods: The study included the evaluation of 174 pregnancies of women with T1D in follow-up from January/2008 to December/2021. Data were collected from the participants during follow-up and recorded in a database. Variables of interest were compared between groups (CSII versus MDI) and logistic regression analysis were performed, p<0.05. Results: From 174 pregnancies evaluated, 21.3%(37) used CSII and 78.7%(137) MDI, with a mean age of 26.7(5.4) years old. Mean levels of lipid profile variables, presence of chronic hypertension, pre-gestational BMI and weight gain were similar in both groups, while hypothyroidism was more prevalent in CSII users [32.4 vs. 17.5%, p=0.047] than MDI users. There was an improvement in HbA1c throughout gestation in both groups, but there was no difference in HbA1c values at the first trimester of pregnancy [8.3(1.7) vs. 8.8(1.8)%, p=0.122] and at the 3rd trimester [6.9(0.8) vs. 7.1(1.0)%, p=0.611] comparing CSII vs. MDI, respectively. The frequency of cesarean section was significantly higher in the CSII group [94.1 vs. 75.4%, p=0.017], but there was no statistical difference in the frequency of other complications, such as miscarriage, premature delivery and preeclampsia, as well as in mean of birth weight and occurrence of neonatal complications, such as perinatal death, hyperbilirubinemia, respiratory distress, hypoglycemia and NICU admission, except for the proportion of congenital malformations that was significantly lower in the CSII group [2.9 vs. 15.6%, p=0.048]. In regression analysis, association of CSII with cesarean section and with malformations lost significance after adjustments for HbA1c in the first adjusted model and persisted non-significant after adjustments for other covariates of interest. Conclusions: In this study, the use of CSII was associated with a higher frequency of cesarean section and a lower occurrence of congenital malformations, that lost statistical significance after xii adjustments for possible confounders. The higher cesarean section rate might be representing more severe cases of DM, since these patients had a longer duration of DM and the profile of insulin pump users in Brazil is usually more challenging. Although there was no difference in HbA1c values when compared to the MDI group, the lower frequencies of malformations in CSII group might be mediated by glucose control during early pregnancy, as we observed a trend towards worse HbA1c trajectories values during pregnancy in those women with than those without malformation outcome. The evaluation of other parameters of glycemic control, such as glycemic variability and time in range, might clarify this hypothesis in future researches regarding comparison of CSII and MDI treatments for T1D in pregnancy. There was no difference in other maternal-fetal outcomes between the two groups.
Introduction: Pregnant women with type 1 diabetes (T1D) have an increased risk of maternal-fetal complications. Regarding treatment, continuous subcutaneous insulin infusion (CSII) has advantages compared to multiple daily injections (MDI), but data about the best option during pregnancy is limited. Objectives: To compare maternal-fetal outcomes of pregnant women with T1D using CSII or MDI during pregnancy. Methods: The study included the evaluation of 174 pregnancies of women with T1D in follow-up from January/2008 to December/2021. Data were collected from the participants during follow-up and recorded in a database. Variables of interest were compared between groups (CSII versus MDI) and logistic regression analysis were performed, p<0.05. Results: From 174 pregnancies evaluated, 21.3%(37) used CSII and 78.7%(137) MDI, with a mean age of 26.7(5.4) years old. Mean levels of lipid profile variables, presence of chronic hypertension, pre-gestational BMI and weight gain were similar in both groups, while hypothyroidism was more prevalent in CSII users [32.4 vs. 17.5%, p=0.047] than MDI users. There was an improvement in HbA1c throughout gestation in both groups, but there was no difference in HbA1c values at the first trimester of pregnancy [8.3(1.7) vs. 8.8(1.8)%, p=0.122] and at the 3rd trimester [6.9(0.8) vs. 7.1(1.0)%, p=0.611] comparing CSII vs. MDI, respectively. The frequency of cesarean section was significantly higher in the CSII group [94.1 vs. 75.4%, p=0.017], but there was no statistical difference in the frequency of other complications, such as miscarriage, premature delivery and preeclampsia, as well as in mean of birth weight and occurrence of neonatal complications, such as perinatal death, hyperbilirubinemia, respiratory distress, hypoglycemia and NICU admission, except for the proportion of congenital malformations that was significantly lower in the CSII group [2.9 vs. 15.6%, p=0.048]. In regression analysis, association of CSII with cesarean section and with malformations lost significance after adjustments for HbA1c in the first adjusted model and persisted non-significant after adjustments for other covariates of interest. Conclusions: In this study, the use of CSII was associated with a higher frequency of cesarean section and a lower occurrence of congenital malformations, that lost statistical significance after xii adjustments for possible confounders. The higher cesarean section rate might be representing more severe cases of DM, since these patients had a longer duration of DM and the profile of insulin pump users in Brazil is usually more challenging. Although there was no difference in HbA1c values when compared to the MDI group, the lower frequencies of malformations in CSII group might be mediated by glucose control during early pregnancy, as we observed a trend towards worse HbA1c trajectories values during pregnancy in those women with than those without malformation outcome. The evaluation of other parameters of glycemic control, such as glycemic variability and time in range, might clarify this hypothesis in future researches regarding comparison of CSII and MDI treatments for T1D in pregnancy. There was no difference in other maternal-fetal outcomes between the two groups.