Adherence to postpartum diabetes mellitus screening, do associated pregnancy complications make a difference?

diabetes research and clinical practice

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Diabetes Research and Clinical Practice journal homepage: www.elsevier.com/locat e/dia bre s

Adherence to postpartum diabetes mellitus screening, do associated pregnancy complications make a difference? Reut Rotem a,*,1, Simrit Salem-Yaniv b,1, Hadar Sandler-Rahat b, David Yohay b, Shanny Sade b, Lior Yahav b, Adi Y. Weintraub b a

Department of Obstetrics and Gynecology, Shaare Zedek Medical Center, Affiliated with the Hebrew University Medical School of Jerusalem, Jerusalem, Israel b Department of Obstetrics and Gynecology, Gynecology, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel

A R T I C L E I N F O

A B S T R A C T

Article history:

Aims: We aimed to investigate the impact of Gestational Diabetes Mellitus (GDM) compli-

Received 28 October 2019

cations on compliance with postpartum Diabetes screening.

Received in revised form

Methods: A retrospective cohort study was conducted comparing screening rates of women

16 November 2019

with and without GDM associated complications who delivered at the Soroka University

Accepted 29 November 2019

Medical Center, between 2016 and 2017. The screening test of choice was a 2-hour 75 g oral

Available online 2 December 2019

glucose tolerance test, taken 6–12 weeks after delivery. GDM associated complications included one or more of the following: polyhydramnios, macrosomia, shoulder dystocia

Keywords: Gestational diabetes mellitus Diabetes screening Post-partum follow up Macrosomia Polyhydramnios Shoulder dystocia Cesarean section

or cesarean section. Univariate analysis was used in order to examine if GDM associated complications were associated with postpartum diabetes screening. Results: During the study period a 164 women were included, of which, 82 women had suffered from GDM associated complications and comprised the study group and 82 women with GDM but without complications comprised the comparison group. Women in the study group were significantly older with a higher parity order. Induction rates were significantly higher among the comparison group, whereas, cesarean section rates were higher among the study group. No difference was noted with regard to neonatal outcomes. Women in the study group were not found to be more likely to be given screening recommendations at discharge (P = 0.50), at their postpartum visit (P = 0.36) or to perform DM screening postpartum (P = 0.17). Conclusion: Women with GDM associated complications had a higher rate of compliance to postpartum DM screening recommendations. However, in the current study this difference did not reach statistical significance. Ó 2019 Published by Elsevier B.V.

* Corresponding author. E-mail address: [email protected] (R. Rotem). 1 The first and second authors to be considered equal contributors to this manuscript. https://doi.org/10.1016/j.diabres.2019.107972 0168-8227/Ó 2019 Published by Elsevier B.V.

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1.

diabetes research and clinical practice

Introduction

An estimated 6–9% of pregnancies are complicated by diabetes mellitus, with approximately 90% attributed to Gestational Diabetes Mellitus (GDM) [1]. When implementing the International Association of the Diabetes and Pregnancy Study Group (IADPSG) guidelines prevalence of GDM may reach up to 25.5% [2]. For any given population the rate of GDM reflects the prevalence of Type 2 Diabetes Mellitus (T2DM) and varies according to obesity rates, age and race [3,4]. Current screening recommendations during pregnancy include a 50-g screening test (GCT) to all pregnant women between 24 and 28 weeks of gestation followed by a 100-g tolerance test when GCT results are 140 mg/dl [1]. Women diagnosed with GDM are at increased risk for pregnancy complications such as polyhydramnios, macrosomia, shoulder dystocia and cesarean delivery [5]. Rates of T2DM diagnosed post-partum range from 2 to 12.5% within one year and up to 30–60% after 10 years. Overall, women with GDM are seven times more likely to develop T2DM than women without GDM [6]. GDM is also associated with higher rates of hypertension, dyslipidemia, vascular dysfunction, atherosclerosis and major cardio-vascular events later in life [7]. Therefore, screening for T2DM is recommended for all women with GDM, 6–12 weeks post-partum [5]. The screening test of choice is a 2-hour 75 g oral glucose tolerance test (OGTT) [4,8]. Identifying women at risk is important for prevention and perhaps delaying the onset of T2DM and its associated morbidity by offering interventions such as lifestyle modifications or medications. Early diagnosis can decrease the harmful effects of a hyperglycemic state on future pregnancies and general health [9]. Despite recommendations for post-partum screening, only 23–54% of women diagnosed with GDM perform the recommended tests [5]. Previous studies have aimed to identify factors predicting likelihood of follow up OGTT testing and demonstrated that the following factors are associated with higher compliance rates: older age, obesity, nulliparity, higher income and education, prenatal care, insulin treatment during pregnancy and attending a post-partum follow up visit [10,11]. Our study aimed to investigate the impact of gestational diabetes associated pregnancy complications (polyhydramnios, macrosomia, shoulder dystocia and cesarean section) on compliance with postpartum diabetes mellitus screening.

2.

Materials and methods

2.1.

Study design

A retrospective cohort study of women with GDM who gave birth in a single tertiary center, Soroka University Medical Center, between 2016 and 2017. Women with GDM associated complications were compared to women without GDM associated complications. Women with a multiple gestation, GDM in past pregnancies or pre-gestational DM were excluded from the study.

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The study protocol was approved by the Soroka University medical center research ethics Board. (#0333-17-SOR). GDM associated complications were defined as a composite with at least one of the following: macrosomia (birth weight >4000 g) [1], polyhydramnios (AFI > 25 cm or more than 8 cm in one pocket) [12], shoulder dystocia or cesarean delivery (elective due to suspected macrosomia or urgent due to none-progressive labor (NPL) or suspected fetal distress). Diagnosis of macrosomia and polyhydramnios on medical records was determined by obstetricians, according to the International Classification of Diseases 9th revision (ICD-9). The data was revised by the researchers. GDMA1 was defined as GDM controlled by diet and lifestyle modification while GDMA2 was defined as GDM controlled by medications. In order to avoid bias where women with GDMA2 will demonstrate higher adherence rates we electively distributed GDMA1 and GDMA2 equally within the study groups. Women diagnosed with GDM related complications comprised the study group. The comparison group consisted of women diagnosed with GDM with no complications who have delivered during the same time period.

2.2.

Data collection

Cases were identified using the using the institutional birth registry of the Soroka University Medical Center. Maternal and neonatal charts were then reviewed for the following information: patients demographic and clinical characteristics, type of GDM, the existence of any GDM complication (macrosomia, shoulder dystocia, CS or polyhydramnios), antepartum Maternal Fetal Medicine (MFM) clinic follow up, postpartum screening recommendations at discharge, attending a postpartum visit, time to postpartum visit, recommendation for screening at postpartum visit, DM screening execution, type of DM screening and time to DM screening. Postpartum visit and DM screening were considered to be carried out if they had been preformed within 60 days of discharge from the hospital.

2.3.

Statistical analysis

The initial analysis was performed by using descriptive statistics (mean, SD, graphs), followed by advanced analytical statistics using various parametric tests. Continuous variables with normal distribution were presented as mean ± SD and compared between the study groups using t-test (maternal age). Continuous variables which weren’t normally distributed were presented as median with inter-quartile range and their statistical analysis was performed by using the MannWhitney test (gestational age). Categorical variables were presented in counts and percentages and their statistical analysis was performed by using Chi-Square or Fisher Exact test when appropriate (mode of delivery). All analysis with two-sided pvalue of <0.05 were considered significant. Sample size calculation was done based on the reported rate of postpartum screening of 23–54% [5]. Screening rates for women with diabetes related complications were esti-

diabetes research and clinical practice

mated to be 40% whereas among diabetic women without complications to be 20%. Given an alpha of 0.05 and beta of 0.8, the sample size required is 164 (82 in each group). Calculation was done using the WinPepi program. It should by emphasized that any effect size smaller than double screening rates would be considered not significant in this given sample size.

3.

Results

Eighty-two women who met the inclusion criteria and had suffered from GDM associated complications were included and had comprised the study group. Of those, 25 (=30.5%) delivered a child with macrosomia, 15 (=18.3%) had polyhydramnios during pregnancy, 67 (=81.7%) of the pregnancies were delivered by CS. There were no cases of shoulder dystocia. Twenty-one women in the study group had more than one GDM complication. A second group of 82 women with GDM and no complications who have delivered during the same period formed the comparison group. Table 1 displays the demographic and clinical characteristics of both groups. Women with GDM complications were older (P = 0.031), had higher gravidity and parity (P < 0.01) and were more likely to have had a previous CS (P < 0.001). Pregnancy characteristics of both groups are presented in Table 2. No significant differences were demonstrated with regard to preeclampsia, placental abruption and intrauterine growth restriction between the groups. Delivery and Neonatal characteristics of both groups are displayed in Table 3. Women with GDM associated complica-

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tions gave birth earlier (38.47 weeks vs. 38.99 P = 0.017) and were less likely to have undergone an induction of labor (P < 0.001) with higher rates of caesarean section. No differences were noted in neonatal outcomes between the groups. Of 164 women who participated in the study, 96 women had a documented recommendation to perform DM screening at any stage (discharge or postpartum visit) while the remaining 68 no such recommendation was documented. Of those who received a recommendation, only 21 (21/96, 21.6%) have carried out a screening test. Eleven (11/68, 16.2%) of the women with no documented recommendation have performed DM screening postpartum. We followed all 96 women who eventually received a screening recommendation in order to track at which point the recommendation was given: 1. Eighty-three (83/96, 86.5%) women were advised to perform a DM screening test at discharge and of these 20 (24%) have performed a screening test. 2. Two (2/96 2.1%) women were given a recommendation for screening during their postpartum visit and only one has preformed it. 3. Eleven women (11/96, 11.4%) were advised to perform a screening test both at discharge and during their postpartum visit, of these only two (2/1118.2%) have followed through. We have found no significant difference in the screening rate with regard to the timing of the recommendation whether it was given during discharge, at a postpartum visit or during both (P = 0.67). Table 4 presents data on postpartum diabetes mellitus screening recommendations and rates. We have found no difference in the rates of screening recommendations given to

Table 1 – Demographic and clinical characteristics of women with and without GDM associated complications. Variable

GDM associated complications N = 82

GDM without complications N = 82

P-Value

Maternal age, y (Mean ± SD) Ethnicity, N (%) Jewish Bedouins Other Smoking, N (%) Gravidity, (median, mode) Parity, (median, mode) Bad obstetric history, N (%) s/p CS, N (%)

43.60 ± 5.70 40 (48.8%) 40 (48.8%) 2 (2.4%) 7 (8.5%) 3,1 3,1 9 (11%) 30 (36.6%)

30.61 ± 6.05 40 (58.5%) 33 (40.2) 1 (1.2%) 7 (8.5%) 2,1 2,1 8 (9.8%) 4 (4.9%)

<0.05 0.42

1 <0.05 <0.05 0.80 <0.001

GDM – gestational diabetes mellitus, SD – standard deviation, s/p CS – status post cesarean section.

Table 2 – Pregnancy characteristics of women with and without GDM associated complications. Variable

GDM associated complications N = 82

GDM without complications N = 82

P-Value

Gestational HTN N (%) Preeclampsia (N%) PPROM (N%) Diabetes typeN (%) GDM1 GDM2 IUGR (N%) Placental abruption (N%) Preterm delivery (N%)

4 (4.9%) 4 (4.9%) 1 (1.2%) 60 (73.2%) 22 (26.8%) 1 (1.2%) 0 (0.0%) 4 (4.9%)

2 (2.4%) 4 (4.9%) 1 (1.2%) 60 (73.2%) 22 (26.8%) 2 (2.4%) 0 (0.0%) 2 (2.4%)

0.43 1.00 1.00 1.00 0.53 – 0.34

GDM – gestational diabetes mellitus, HTN – hypertension; PPROM – preterm pre-labor rupture of membranes; IUGR – intra uterine growth restriction.

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Table 3 – Delivery and neonatal characteristics of women with and without GDM associated complications. Variable

GDM associated complications N = 82 GDM without complications N = 82 P-Value

Induction of labor (N%) CS (N%) Vacuum assisted delivery (N%) PPH (N%) Gestational age at delivery (Mean ± SD) Gender of offspring- N (%) Female Male Birth weight, gr (Mean ± SD) Apgar score 1 min (Median, mode) Apgar score 5 min (Median, mode)

22 (26.8%) 67 (81.7%) 0 (0.0%) 1 (1.2%) 38.47 ± 1.39 48 (58.5%) 40 (48.8%) 3488.02 ± 660.34 (9,9) (10,10)

44 (53.7%) 0 (0.0%) 4 (4.9%) 3 (3.7%) 38.99 ± 1.36 34 (41.5%) 42 (51.2%) 3410.11 ± 385.05 (9,9) (10,10)

<0.05 <0.05 0.06 0.39 <0.05 0.26 <0.05 0.33 0.44

GDM – gestational diabetes mellitus, SD – standard deviation, PPH- postpartum hemorrhage.

Table 4 – Postpartum diabetes mellitus screening among women with and without GDM associated complications. Variable

GDM associated complications N = 82

GDM without complications N = 82

P-Value

Antepartum MFM clinic follow up N (%) Postpartum screening recommendation at dischargeN (%) Postpartum visit N (%) Time to postpartum visit in days (Mean ± SD) Recommendation for screening at postpartum visit N (%) Diabetes mellitus screening N (%) Type of screening N (%) 75 gr OGTT Fasting glucose HbA1C Time to screening in days (Mean ± SD)

33 (40.2%) 45 (54.9%) 45 (54.9%) 41.42 ± 13.19 5 (11.4%) 20 (24.4%) 5 (25.0%) 7 (35.0%) 8 (40.0%) 35.10 ± 16.83

37 (45.1%) 49 (59.8%) 43 (52.4%) 41.93 ± 9.50 8 (18.2%) 12 (14.6%) 4 (33.3%) 2 (16.7%) 6 (50%) 44.00 ± 11.21

0.51 0.55 0.75 0.84 0.36 0.17 0.56

0.14

GDM – gestational diabetes mellitus, SD – standard deviation, MFM – maternal Fetal Medicine; DM – diabetes mellitus, OGTT – oral glucose tolerance test, HbA1C – hemoglobin A1C.

patients at discharge (P = 0.5) or during the postpartum visit (P = 0.36) whether they had GDM complications or not. No differences were noted in the rates of postpartum visits (P = 0.75) or in the rate of screening (P = 0.17) between women with and without GDM associated complications. Three different methods of post-partum screening were applied (75 OGTT, fasting glucose and HBA1C). Overall, only 9 women had taken 75 gr OGTT, 9 underwent a fasting glucose test and HBA1C was measured in the remaining 14 patients. We have found a significant difference in the rate of postpartum DM screening between women who attended an MFM clinic follow up during pregnancy as opposed to those managed by obstetricians in the community setting, (58% vs. 42% P = 0.05). All of the nine women who had performed the advised 75 g OGTT attended an MFM clinic follow up antepartum (P < 0.05). Two of these nine women, were diagnosed as diabetic.

4.

Discussion

In the present study we aimed to investigate a possible association between GDM complications and compliance with postpartum DM screening. We found higher rates of screening amongst women with GDM complications (24.4%) than

in the comparison group (14.6%). However, although the screening rate was almost doubled this difference did not reach statistical significance (P = 0.17). Overall in both groups combined, 19.5% of women with GDM preformed a screening test, which is a lower rate than previously reported [4]. A post hoc power analysis was performed. The power of the test assuming a population effect size exactly equal to the effect size observed in our study, given an alpha of 0.05, was calculated to be 35.6%. Hence, our given sample is underpowered to detect a significant difference in the current sample. Rates of previous CS were significantly higher among the study group. This may explain in part recurrent operations done due to NPL which could be attributed to intrinsic pelvic factors and not necessarily diabetic related. Therefore, we performed a subgroup analysis of a new composite outcome without CS. No significant differences were noted in the postpartum screening recommendation given, nor in actual screening rates. Capula et al. [12] demonstrated that 32% of women diagnosed with GDM are pre-diabetic at 6–12 weeks postpartum and 4% are diagnosed with T2DM during this time frame [12]. These women can benefit greatly from early treatment and lifestyle modifications in order to reduce the harmful

diabetes research and clinical practice

effects of hyperglycemia. In our study 2/9 women (22.2%) who performed the advised 75 g OGTT were diagnosed as diabetic. Although this represents a higher rate of diabetes than described in the literature [12], it may be attributed to the fact that only a small number of women had performed this test. Our findings suggest that the timing of screening recommendations, as well as repeated recommendations did not affect the rate of postpartum screening, this is in accordance with previous studies [13,14]. However, women who attended an MFM specialist clinic were found more likely to perform a postpartum screening test (p = 0.05). These findings are in accordance with the findings of Rosenbloom et al. [15], who conducted a study aimed at understanding the relationship between the role and level of training of the primary care giver and the rate of postpartum DM screening. In their study, patients seen by resident physicians or midwifes, as opposed to attending physicians, were more likely to perform a postpartum screening test [15]. Increasing women’s compliance with postpartum screening is an important issue that has been previously addressed [13–16]. The low rate of screening in our study can be attributed to several factors. From the patients’ perspective, our region has a high prevalence of patients with poor prenatal care which may be in association with poor patients’ compliance and adherence with postpartum care [17,18]. In fact, only half of the women in our study have attended a postpartum visit. Additionally, the fact that less than 60% of patients with GDM had a documented recommendation for screening can also explain the low screening rate. By making sure to provide the appropriate recommendations and encouraging physicians to emphasize postpartum screening this number could potentially increase. An emphasis should be put on patient education and awareness. Health educational sessions with an nurse or physician may be beneficial in increasing awareness to the importance of postpartum DM screening and might increase the screening rates. Our study’s strength is that our medical center is the only tertiary medical center in the south of Israel and serves the entire population therefor represents unselected data. Another strength lies in the fact that medical information about hospitalization, outpatient visits, visits in the community clinics (primary clinics) and tests results are available through the computerized medical records of our patients. This allowed us to evaluate the rate of patients who have attended a postpartum visit and screening. Finally, we believe that this study has the advantage of novelty since to the best of our knowledge this is the first study to address the issue of the impact of GDM associated pregnancy complications on postpartum DM screening. However, our study is not without limitations. First, in our population there is a high rate of women with poor prenatal care who are less likely to attend a postpartum visit or carry out the recommended screening tests. Secondly, there was no uniformity in terms of the screening recommendations given to women. Some women were given recommendations at discharge, some during their postpartum visit, and some did not receive any such recommendations. This makes it difficult to assess whether GDM complications influence postpartum DM screening. Finally, given the effect size in the

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current sample our study was underpowered to detect statistically significant differences in compliance to postpartum GDM screening, however we believe this difference to be clinically significant. In conclusion, rates of DM screening in women with GDM are generally low. This may be attributed not only to lack of patients’ compliance but also and perhaps most importantly to the relatively low rates of postpartum screening recommendation given by physicians. Women with GDM complications were found to be more likely to perform DM screening.

Declaration of Competing Interest None.

Acknowledgments Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Contribution of authorship: RR: conception, planning, carrying out, analyzing and writing up the work. SSY: conception, planning, carrying out, analyzing and writing up the work. HSR: carrying out and writing up the work. DY: conception, planning, writing up the work. SS: conception, planning, writing up the work. LY: conception, planning, carrying out, analyzing and writing up the work. AYW: conception, planning, carrying out, analyzing and writing up the work. Details of ethics approval: The study was approved by the local institutional ethics committee in accordance with the principles of the Declaration of Helsinki (IRB approval number: #0333-17-SOR Soroka University Medical Center Research Ethics Board, July 2018). Data were obtained anonymously from medical records, with no direct participation of patients and hence written informed consent was waived.

Appendix A. Supplementary material Supplementary data to this article can be found online at https://doi.org/10.1016/j.diabres.2019.107972.

R E F E R E N C E S

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