Non-efficacy of early intervention strategy for non-obese patients with early-onset gestational diabetes mellitus: solely based on the short-term outcomes.

INTRODUCTION: To verify the effectiveness of intervention in early pregnancy for women with early-onset gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS: This study included women with a singleton pregnancy who were diagnosed with early-onset GDM by 20 weeks of gestation according to the International Association of Diabetes and Pregnancy Study Group (IADPSG) threshold. We retrospectively evaluated the pregnancy outcomes in pregnant women with early-onset GDM. In the treatment from early pregnancy group (n=286), patients were diagnosed with early-onset GDM at the Yokohama City University Medical Center (YCU-MC) in 2015-2017 and were treated for GDM from early pregnancy. Concerning the treatment from mid-pregnancy group (n=248), participants were diagnosed with early-onset GDM at five sites, including the YCU-MC in 2018-2019, and were followed up without treatment until the second 75 g oral glucose tolerance test (OGTT) at 24-28 weeks of gestation. Treatment for GDM was given only if the GDM pattern was still present in the second OGTT. RESULTS: There were no significant differences in maternal backgrounds, including GDM risk factors and gestational weight gain, between the groups. Among the treatment from mid-pregnancy group, the false-positive early GDM was 124/248 (50%). Regarding pregnancy outcome, the rate of large for gestational age (LGA) was 8.8% in the treatment from early pregnancy group and 10% in the treatment from mid-pregnancy group, with no significant difference, whereas small for gestational age (SGA) was significantly higher in the treatment from early pregnancy group (9.4%) than in the treatment from mid-pregnancy group (4.8%) (p=0.046). There were no significant differences in maternal adverse events and neonatal outcomes between the groups. In a subanalysis limited to body mass index >25 kg/m2, LGA was significantly lower in the treatment from early pregnancy group than in the treatment from mid-pregnancy group. CONCLUSIONS: The strategy for diagnosing GDM by IADPSG thresholds in early pregnancy and providing treatment to all patients from early pregnancy did not improve the pregnancy outcomes, but rather increased the SGA rate.

Do pregnancy outcomes of women with false-positive early gestational diabetes mellitus differ from those of women with normal glucose tolerance?

BACKGROUND: To investigate whether false-positive early gestational diabetes mellitus (GDM) women can be managed similarly as normal glucose tolerance (NGT) women. METHODS: This retrospective study was conducted at a tertiary care center in Japan. Pregnancy and neonatal outcomes of 67 singleton pregnancies with false-positive early GDM and 1774 singleton pregnancies with NGT who delivered after 22 weeks of gestation were compared. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria (patients having one or more of the following: fasting plasma glucose ≥ 92 mg/dL and a 75 g oral glucose tolerance test (OGTT) value ≥ 180 mg/dL at 1 h, or ≥ 153 mg/dL at 2 h). Pregnant women diagnosed with GDM in early pregnancy who did not meet the diagnostic criteria on the second OGTT were defined as having false-positive early GDM. Women with false-positive early GDM did not receive any therapeutic intervention during gestation. RESULTS: Maternal age, pre-pregnancy body mass index, and gestational weight gain were significantly higher in the false-positive GDM group than in the NGT group. No significant differences were found in pregnancy outcomes, including gestational age, birth weight, large for gestational age rate, and cesarean delivery rate. Except for a higher neonatal hypoglycemia rate in the false-positive early GDM group, no significant differences were found in neonatal outcomes. CONCLUSIONS: There were no clinically significant differences between early GDM false-positive women exhibiting GDM patterns only during early pregnancy and NGT women. False-positive early GDM women can be managed similarly as NGT women, suggesting that World Health Organization diagnostic guidelines, applying the IADPSG criteria during early pregnancy, need revision.

Effect of interventions in pregnant women with mildly impaired glucose tolerance.

AIM: In 2010, the Japan Society of Obstetrics and Gynecology (JSOG) changed the diagnostic criteria for gestational diabetes mellitus (GDM) to follow the International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria. As a result, many pregnant women with mildly impaired glucose tolerance (IGT) were newly diagnosed with GDM. This study aimed to verify the effects of interventions in pregnant women with mild IGT who were newly diagnosed with GDM based on the present JSOG criteria. METHODS: We defined mild IGT as a degree of IGT that would be diagnosed as GDM according to the present but not the previous JSOG criteria. We compared pregnancy and delivery outcomes in women with mild IGT who delivered a singleton at 22 weeks of gestation or later, between 2000 and 2009 (untreated group, n = 503) versus between 2011 and 2017 (treated group, n = 781). RESULTS: The incidence of GDM-related composite complications such as macrosomia, shoulder dystocia, neonatal hypoglycemia, neonatal hyperbilirubinemia, and neonatal respiratory distress syndrome was comparable in the untreated and treated groups (10.1% vs. 11.9%, p = 0.11). The pregnancy outcomes were also comparable, except for infant birth weights, which were lower in the treated group than in the untreated group (3014 g vs. 3094 g; p = 0.02). CONCLUSIONS: Pregnancy outcomes were not affected by the interventions in pregnant women with mild IGT.

High probability of false-positive gestational diabetes mellitus diagnosis during early pregnancy.

INTRODUCTION: This study aimed to assess the validity of applying the International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria for the diagnosis of gestational diabetes mellitus (GDM) at any time during pregnancy. RESEARCH DESIGN AND METHODS: This multicenter cohort study was conducted at five Japanese facilities from January 2018 to April 2019. The study cohort included women at a high risk of GDM who met one or more of the following IADPSG criteria during early pregnancy: fasting plasma glucose (FPG) ≥92 mg/dL and 75 g oral glucose tolerance test (OGTT) value of ≥180 mg/dL at 1 hour, or ≥153 mg/dL at 2 hour (hereafter early-onset GDM). Women diagnosed with early-onset GDM were followed up without therapeutic intervention and underwent the 75 g OGTT again during 24-28 weeks of gestation. Those exhibiting the GDM patterns on the second 75 g OGTT were diagnosed with true GDM and treated, whereas those exhibiting the normal patterns were diagnosed with false positive early GDM and received no therapeutic intervention. RESULTS: Of the 146 women diagnosed with early-onset GDM, 69 (47%) had normal 75 g OGTT values at 24-28 weeks of gestation, indicating a false-positive result. FPG levels were significantly higher in the first 75 g-OGTT test than in the second 75 g-OGTT test (93 mg/dL and 87.5 mg/dL, respectively; p<0.001). FPG levels were high in 86 (59%) women with early-onset GDM during early pregnancy but in only 39 (27%) women during mid-pregnancy. Compared with false positive early GDM, true GDM was more frequently associated with adverse pregnancy outcomes. CONCLUSIONS: Although women with early-onset GDM were followed up without treatment, the results of repeated 75 g OGTT during mid-pregnancy were normal in about 50%. Our data did not support the adoption of IADPSG thresholds for the diagnosis of GDM prior to 20 weeks of gestation.

Have pregnancy outcomes improved with the introduction of the International Association of Diabetes and Pregnancy Study Groups criteria in Japan?

AIMS/INTRODUCTION: This study aimed to investigate the effects of the introduction of the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria for diagnosing gestational diabetes mellitus (GDM) on maternal and neonatal outcomes in Japan. MATERIALS AND METHODS: This was a retrospective study carried out at a tertiary center in Japan. Previously in Japan, GDM was diagnosed if two or more of the following Japan Society of Obstetrics and Gynecology (JSOG) criteria were met: fasting plasma glucose ≥100 mg/dL, 1-h value ≥180 mg/dL or 2-h value ≥150 mg/dL on the 75-g oral glucose tolerance. Since 2010, GDM has been diagnosed if one or more of the following IADPSG criteria are met: fasting plasma glucose ≥92 mg/dL, 1-h value ≥180 mg/dL or 2-h value ≥153 mg/dL on the 75-g oral glucose tolerance. We compared the pregnancy outcomes of all pregnant women with singleton pregnancies after 22 weeks' gestation at our hospital before (JSOG period) and after (IADPSG period) the IADPSG criteria were adopted. RESULTS: There were 3,912 women in the JSOG period and 4,772 in the IADPSG period. GDM prevalence increased from 2.9% in the JSOG period to 13% in the IADPSG period (P < 0.001). No significant differences between the groups were found in rates of macrosomia, or large for gestational age, and no significant differences were found in birthweight. The neonatal hypoglycemia rate and neonatal intensive care unit admission rate were significantly lower in the IADPSG period (adjusted odds ratio 0.51 and 0.78, respectively). CONCLUSIONS: Introduction of the IADPSG criteria for diagnosing GDM increased GDM diagnosis frequency fourfold, but reduced neonatal intensive care unit admission and neonatal hypoglycemia rates significantly.

Impact of introducing the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria on pregnancy outcomes in Japan.

To estimate pregnancy complications in women newly diagnosed with gestational diabetes mellitus (GDM) according to the new International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria and verify the validity of introducing the IADPSG criteria in Japan. This retrospective study included data from women with singleton delivery at 22 weeks or later at a tertiary hospital during 2000-2009. We compared pregnancy outcomes between women who would now be diagnosed with GDM according to the IADPSG criteria but not by the old JSOG criteria (IGT group, n = 503) and women with normal glucose tolerance according to both the criteria (NGT group, n = 2,789). Multivariate analysis was performed and adjusted for background factors. Maternal age at delivery and pre-pregnancy BMI were significantly higher in the IGT group than in the NGT group, while gestational weeks at delivery did not differ between the groups. No difference was observed in the rates of GDM-related composite complications (defined as cases with at least one of the following: macrosomia, shoulder dystocia, neonatal hypoglycemia, neonatal hyperbilirubinemia, or neonatal respiratory distress syndrome) at 11.9% and 8.8% (adjusted odds ratio (OR) 1.30, 95% confidence interval (CI) 0.90-1.87, p = 0.16). Pregnancy outcomes did not differ significantly between the IGT and NGT groups, except for frequencies of total neonatal admissions at 10.5% and 7.1%, respectively (adjusted OR 1.55, 95% CI 1.12-2.13, p < 0.01).

Should the IADPSG criteria be applied when diagnosing early-onset gestational diabetes?

AIMS: To investigate whether the broad interpretation of the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria with application to the early pregnancy, which is adopted as the standard in Japan, is appropriate. METHODS: We conducted this investigation by comparing diabetes-related adverse pregnancy outcomes among women treated for gestational diabetes mellitus (GDM) following an early-pregnancy diagnosis (early-onset GDM, n = 528) and those treated for GDM following a mid-pregnancy diagnosis, which is the international standard (Mid-term-onset GDM, n = 147). RESULTS: Gestational weight gain was significantly lower in the early-onset GDM group (7.5 kg) than in the mid-term-onset GDM group (8.4 kg). The frequency of hypertensive disorders of pregnancy tended to be lower in the early-onset GDM group (5.6% vs. 8.8%, p = 0.085), but infant birth weight did not differ significantly between the groups. No between-group difference was observed in macrosomia, large-for-gestational-age (LGA), small-for-gestational age (SGA), low Apgar score, shoulder dystocia, cesarean delivery, NICU admission, hyperbilirubinemia, neonatal hypoglycemia, or respiratory distress syndrome. The frequency of LGA showed a significant association with pre-pregnancy body mass index, but did not differ according to the timing of therapy initiation. CONCLUSIONS: We could not find the effectiveness of therapeutic interventions initiated after GDM diagnosis in the early pregnancy based on the IADPSG criteria, compared with therapeutic interventions after a mid-pregnancy GDM diagnosis. It was suggested that the IADPSG criteria for diagnosing GDM at 24-28 weeks' gestation should not be applied to Japanese women in the early pregnancy by a broader interpretation.

Hygroscopic dilators vs balloon catheter ripening of the cervix for induction of labor in nulliparous women at term: Retrospective study.

OBJECTIVE: To compare the efficacy and safety of hygroscopic dilators and balloon catheters for ripening of the cervix in induction of labor. STUDY DESIGN: This retrospective, observational study used data from the Successive Pregnancy Birth Registry System of the Japan Society of Obstetrics and Gynecology from 2012 to 2014. Nulliparous women in whom labor was induced by mechanical methods of cervical ripening at term were enrolled. The eligible women were divided into dilator, balloon <40 mL, balloon ≧40 mL, and overlapping groups. RESULTS: The groups included 4645, 4100, 6615, and 1992 women, respectively. In the overlapping group, which included the women in whom delivery was most difficult, the vaginal delivery rate was lower and the intrauterine infection and neonatal mortality rates were higher than those in the dilator group. No difference in the vaginal delivery rate was observed among the dilator, balloon <40 mL, and balloon ≧40 mL groups (74.6%, 72.3%, and 73.8%, respectively; p>0.05). The vaginal instrumental delivery rate was higher in the two-balloon groups than in the dilator group. The volume of intrapartum hemorrhage was lowest in the dilator group. No significant difference in the frequencies of uterine rupture and intrauterine infection were observed among the dilator and two-balloon groups. With regard to neonatal outcomes, the frequency of a low Apgar score was statistically significantly lower in the dilator group than in the two-balloon groups. Moreover, the frequency of neonatal death tended to be lower in the dilator group than in the two-balloon groups. CONCLUSION: With regard to cervical ripening for labor induction in nulliparous women at term, the vaginal delivery rate on using a dilator and on using a balloon seems to be equivalent. Concerning maternal complications and neonatal outcomes, cervical ripening with hygroscopic dilators in labor induction might be safer.

Emergent Uterine Arterial Embolization Using N-Butyl Cyanoacrylate in Postpartum Hemorrhage with Disseminated Intravascular Coagulation.

Although it is widely accepted that uterine artery embolization (UAE) is an effective therapeutic strategy for postpartum hemorrhage (PPH), no consensus has been reached regarding the efficacy of UAE in patients with PPH with disseminated intravascular coagulation (DIC). This single-center retrospective cohort study included patients treated with UAE using NBCA for PPH between 2010 and 2015. The patients were divided into DIC and non-DIC groups, according to the obstetrical DIC score and the overt DIC diagnostic criteria issued by the International Society of Thrombosis and Haemostasis (ISTH), and their clinical outcomes were compared. There were 28 patients treated with UAE using NBCA. Complete hemostasis was achieved by UAE in 19 of 28 patients. In eight of nine patients with unsuccessful hemostasis, surgical hemostatic interventions were performed after UAE, and hemostasis was achieved in seven patients. UAE using NBCA showed no significant intergroup differences in complete hemostasis according to the presence or absence of DIC based on obstetrical DIC score (70% versus 62.5%, P = 1.000) or ISTH DIC score (54.5% versus 76.5%, P = 0.409). UAE using NBCA may be a useful first-choice treatment for PPH with DIC.

Clinical features of gestational thrombocytopenia difficult to differentiate from immune thrombocytopenia diagnosed during pregnancy.

AIM: To investigate the clinical features of gestational thrombocytopenia (GT) difficult to differentiate from immune thrombocytopenia (ITP) during pregnancy. METHODS: The January 2000-December 2012 hospital database was analyzed to identify women with ITP or GT (after excluding other possible causes of thrombocytopenia) among those first noted to have platelet counts of less than 100 000/µL during pregnancy. The maternal characteristics, platelet count fluctuations and pregnancy outcomes were compared between women with ITP and GT. RESULTS: There were 23 pregnancies (22 women) with thrombocytopenia (GT, 13; ITP, 10). The GT group included five twin pregnancies (38.5%), whereas all pregnancies of the ITP group were singleton pregnancies, with significantly more twin pregnancies in the GT group (P = 0.046). Thrombocytopenia in the first trimester occurred in 70% (7/10) of ITP cases and 23.1% (3/13) of even GT cases. The nadir platelet count was less than 70 000/µL in 100% (10/10) of ITP cases and 30.8% (4/13) of GT cases (P < 0.001). Maternal treatment was required in 80% (8/10) of ITP cases, but in none of the GT cases. The pregnancy outcomes were favorable in both groups, and no case required fetal treatment. CONCLUSION: Gestational thrombocytopenia with platelet counts of less than 10 0000/µL occurred more frequently in twin pregnancies. Although onset of thrombocytopenia in the first trimester and a platelet count of less than 70 000/µL is more common in ITP, these findings were not uncommon in GT. Differentiation between ITP and GT may be feasible only with post-partum changes in the platelet count.