Background: We conducted a randomized clinical trial to determine whether treatment of women with gestational diabetes mellitus reduced the risk of perinatal complications. Methods: We randomly assigned women between 24 and 34 weeks' gestation who had gestational diabetes to receive dietary advice, blood glucose monitoring, and insulin therapy as needed the intervention group or routine care. Primary outcomes included serious perinatal complications defined as death, shoulder dystocia, bone fracture, and nerve palsy , admission to the neonatal nursery, jaundice requiring phototherapy, induction of labor, cesarean birth, and maternal anxiety, depression, and health status. Results: The rate of serious perinatal complications was significantly lower among the infants of the women in the intervention group than among the infants of the women in the routine-care group 1 percent vs. However, more infants of women in the intervention group were admitted to the neonatal nursery 71 percent vs.

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It is uncertain whether treatment of mild gestational diabetes mellitus improves pregnancy outcomes. Women who were in the 24th to 31st week of gestation and who met the criteria for mild gestational diabetes mellitus i.

The primary outcome was a composite of stillbirth or perinatal death and neonatal complications, including hyperbilirubinemia, hypoglycemia, hyperinsulinemia, and birth trauma.

A total of women were randomly assigned to a study group — to the treatment group and to the control group. We observed no significant difference between groups in the frequency of the composite outcome There were no perinatal deaths. However, there were significant reductions with treatment as compared with usual care in several prespecified secondary outcomes, including mean birth weight vs.

Treatment of gestational diabetes mellitus, as compared with usual care, was also associated with reduced rates of preeclampsia and gestational hypertension combined rates for the two conditions, 8. Although treatment of mild gestational diabetes mellitus did not significantly reduce the frequency of a composite outcome that included stillbirth or perinatal death and several neonatal complications, it did reduce the risks of fetal overgrowth, shoulder dystocia, cesarean delivery, and hypertensive disorders.

Gestational diabetes mellitus is defined as glucose intolerance that first occurs or is first identified during pregnancy. Although gestational diabetes mellitus is a recognized marker for an increased risk of subsequent diabetes, its clinical significance with respect to various adverse pregnancy outcomes has been uncertain.

The recent Hyperglycemia and Adverse Pregnancy Outcome HAPO study, however, described a strong continuous association between maternal glucose concentrations and increasing birth weight, cord-blood serum C-peptide levels, and other markers of perinatal complications, even at glucose concentrations below those that are usually diagnostic of gestational diabetes mellitus. Several professional organizations have recommended screening for gestational diabetes mellitus for most pregnant women despite little evidence that the identification and treatment of mild carbohydrate intolerance during pregnancy confer a benefit.

Preventive Services Task Force again concluded that current evidence is insufficient to assess the balance between benefit and harm with respect to the screening and treatment of gestational diabetes mellitus. Women were invited to participate in this study if, between 24 weeks 0 days and 30 weeks 6 days of gestation, they had a blood glucose concentration between and mg per deciliter between 7. Women were excluded if they had preexisting diabetes, an abnormal result on a glucose screening test before 24 weeks of gestation, prior gestational diabetes, a history of stillbirth, multifetal gestation, asthma, or chronic hypertension; if they were taking corticosteroids; if there was a known fetal anomaly; or if imminent or preterm delivery was likely because of maternal disease or fetal conditions.

All the women who pa rticipated in the study provided written informed consent. The study was approved by the human subjects committee at each participating center. After an overnight fast, eligible women completed a blinded 3-hour g oral glucose-tolerance test.

Samples were analyzed at a central laboratory, and results were forwarded to the data coordinating center. Mild gestational diabetes mellitus was defined as a fasting glucose level of less than 95 mg per deciliter 5. Women were assigned to receive either formal nutritional counseling and diet therapy, 12 along with insulin if required treatment group or usual prenatal care control group. In addition, a cohort of women who had a positive result on the g glucose loading test but a normal result on a subsequent oral glucose-tolerance test and who were matched with the study cohort according to race and body-mass index the weight in kilograms divided by the square of the height in meters , dichotomized as less than 27 or 27 or more, were enrolled by the data coordinating center in the group that received usual prenatal care.

By including this group of women who did not have gestational diabetes mellitus, the patients, their caregivers, and the study staff were unaware of whether women in the control group met the criteria for the diagnosis of mild gestational diabetes mellitus. Women with a fasting glucose level of 95 mg per deciliter or more on the diagnostic oral glucose-tolerance test were excluded from the study, and their condition was made known to their health care providers.

Ultrasonography was performed in all subjects before the oral glucose-tolerance test to confirm the gestational age. Women who were receiving treatment performed daily self-monitoring of their blood glucose fasting and 2-hour postprandial measurements with the use of a portable memory-based reflectance meter.

If, during a prenatal visit, there was a clinical suspicion of hyperglycemia in a patient who was in the control group, the blood glucose level could be measured at the discretion of the provider. If a random blood glucose level of mg per deciliter 8. Nonstress testing, biophysical profile testing, and ultrasonography to assess fetal growth were not performed routinely in the treatment group but were reserved for standard obstetrical indications.

However, all the women who were enrolled in the study were instructed regarding the daily assessment of fetal activity. The primary study out come was a composite outcome that included perinatal mortality stillbirth or neonatal death and complications that have been associated with maternal hyperglycemia: hypoglycemia, hyperbilirubinemia, neonatal hyperinsulinemia, and birth trauma.

Cord blood was collected and forwarded to a central laboratory for determination of the C-peptide level. Hyperinsulinemia was defined as a cord-blood C-peptide level greater than the 95th percentile i. Neonatal blood for the determination of glucose level was collected with in 2 hours after birth and before feeding; hypoglycemia was defined as a glucose value of less than 35 mg per deciliter 1.

A value greater than the 95th percentile for any given point after birth was considered to be an elevated level. Secondary prespecified neonatal outcome measures included birth weight greater than g, large size for gestational age defined as birth weight above the 90th percentile , small size for gestational age birth weight below the 10th percentile , 16 admission to the neonatal intensive care unit, and the respiratory distress syndrome. Neonatal fat mass was calculated according to the technique of Catalano et al.

Secondary maternal outcomes included weight gain from the time of enrollment to delivery, gestational hypertension, preeclampsia, cesarean delivery, labor induction, and shoulder dystocia. Gestational hypertension was defined as a systolic pressure of mm Hg or more or a diastolic pressure of 90 mm Hg or more on two occasions at least 4 hours apart, or one elevated blood-pressure value subsequently treated with medication.

Shoulder dystocia was defined clinically, and the providers were required to document the maneuvers that were specifically used to release the fetal shoulders.

Trained study personnel collected data on all the women in the treatment group at the time of the study visits. The records of all enrolled women and their infants were reviewed at the time of their discharge from the hospital, and information regarding antepartum, intrapartum, and post-delivery complications was recorded.

All cases of hypertensive disorders and shoulder dystocia underwent masked central review by two of the authors to ensure that the diagnoses were accurate.

We reviewed the literature to determine the frequency of each component of the composite outcome among women with gestational diabetes mellitus who were not treated for the condition and among those who were treated. The primary analysis of the clinical trial was conducted according to the intention-to-treat principle.

During the course of the trial, an external data and safety monitoring committee periodically reviewed the trial results. From October through mid-November , we identified 19, women who had an abnormal result on a glucose loading test, of whom 10, met the inclusion criteria; consented to undergo a blinded 3-hour oral glucose-tolerance test and to consider enrollment in the randomized trial.

A total of of these women were enrolled; women with mild gestational diabetes mellitus were assigned to the study treatment, and women with mild gestational diabetes mellitus were assigned to receive usual prenatal care. The average time from the performance of the oral glucose-tolerance test to randomization was 4. An additional women with normal results on the oral glucose-tolerance test were included in the group that received usual prenatal care, to mask the status of the control group Fig.

To convert the values for glucose to millimoles per liter, multiply by 0. OGTT denotes oral glucose-tolerance test. The baseline characteristics of the women who were randomly assigned to a study group are shown in Table 1.

There were no significant differences in demographic variables or results of the oral glucose-tolerance test between the women in the treatment group and those in the control group. We observed no significant difference between the treatment group and the control group in the frequency of the composite primary perinatal outcome There were no perinatal deaths in either group.

The individual rates of neonatal hypoglycemia, hyperbilirubinemia, birth trauma, and elevated cord-blood C-peptide level did not differ significantly between the two groups. Adjustment for the baseline reported consumption of any alcohol did not materially affect the relative risk for the primary outcome relative risk with treatment, 0. The frequency of intravenous glucose administration in the newborn did not differ significantly between groups. The mean birth weight and neonatal fat mass, as well as the frequency of large-for-gestational age infants and of infants with a birth weight of g or greater, were significantly reduced in the treatment group as compared with the control group.

In contrast, the frequency of small-for-gestational age infants and the frequency of admission to the neonatal intensive care unit did not differ significantly between the groups Table 3. The rates of labor induction were similar between the treatment and control groups; however, cesarean delivery was significantly less common among women in the treatment group than among women in the control group After excluding cases of abnormal presentation, placenta previa, oligohydramnios, and previous cesarean delivery, the cesarean delivery rate remained lower in the treatment group than in the control group Both the body-mass index at delivery and weight gain from enrollment to delivery were lower among women in the treatment group than among those in the control group Table 4.

A total of 37 women in the treatment group required insulin therapy, as compared with 2 in the control group. Data on maternal glucose levels from women in the treatment group indicated that target glycemic thresholds were achieved Table 5. This randomized trial showed that although treatment of mild gestational diabetes mellitus did not reduce the frequency of the composite primary perinatal outcome, it did lower the risks of fetal overgrowth, shoulder dystocia, cesarean delivery, and preeclampsia.

Overall, consistent with findings from the ACHOIS trial, the findings from our trial confirm a modest benefit from the identification and treatment of women with mild carbohydrate intolerance during pregnancy.

In addition, we used a g diagnostic oral glucose-tolerance test, whereas a g oral glucose-tolerance test was used in the ACHOIS trial. The ACHOIS trial included a health status survey that showed that there were lower rates of postpartum depression in the intervention group, whereas we did not assess quality-of-life measures. Our composite primary outcome included perinatal mortality stillbirth or neonatal death and complications that have been linked to maternal carbohydrate intolerance: neonatal hypoglycemia, hyperbilirubinemia, and birth trauma.

The results of the ACHOIS trial showed that treatment did not reduce the rates of symptomatic neonatal hypoglycemia or jaundice requiring phototherapy. The results from the HAPO study suggested that a threshold for an increased risk of clinical neonatal hypoglycemia may not be apparent until fasting maternal glucose levels exceed mg per deciliter 5.

Associations among macrosomia, shoulder dystocia, and the increased risk of brachial plexus injury in the offspring of women with diabetes are well documented. Increased birth weight and neonatal fat mass may have long-term health implications for the offspring of mothers with gestational diabetes mellitus, including an increased risk of impaired glucose tolerance and childhood obesity.

The diagnosis of gestational diabetes mellitus, or the knowledge that it is present, has been reported to be associated with an increase in several adverse maternal outcomes. The extent to which a reduction in fetal size and in the frequency of large-for-gestational-age infants as a result of treatment may have contributed to the lower rate of cesarean deliveries is unknown. Labor induction and cesarean delivery may be less commonly performed in academic medical centers, including the centers that participated in this study.

Insulin resistance, a characteristic of gestational diabetes mellitus, has been associated with the development of preeclampsia. The overall rate of preeclampsia in our study was substantially lower than that in the ACHOIS study, which is probably explained by our use of more stringent diagnostic criteria.

In contrast with previous randomized trials involving women with gestational diabetes mellitus, we verified compliance with glycemic monitoring and documented whether target glucose thresholds were achieved. We did not disclose the results of oral glucose-tolerance tests to caregivers or subjects in the control group in order to minimize the likelihood of self-treatment, which has been a limitation in pilot studies of treatment of gestational diabetes mellitus.

The majority of outcomes included in the composite outcome of the ACHOIS trial were cases of shoulder dystocia, which is considered by many to be an intermediate health outcome. These findings complement the ongoing analysis of the HAPO study data, which is focused on developing an international consensus for the diagnosis and treatment of carbohydrate intolerance during pregnancy. We thank Lisa Mele, Sc.

Gabbe, M. Iams, F. Johnson, C. Latimer, E. Weinandy, B. Leveno, L. Moseley, J. Gold, D. Bradford, L. Fay, M. Garcia; Columbia University — M. Miodovnik, F. Malone, S.


A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes

Metrics details. It is still uncertain whether there are benefits of similar treatment for women with borderline gestational diabetes. This trial aims to assess whether dietary and lifestyle advice and treatment given to pregnant women who screen for borderline gestational diabetes reduces neonatal complications and maternal morbidities. A conclusive trial outcome will provide reliable evidence of relevance for the care of women with borderline glucose intolerance in pregnancy and their infants. Peer Review reports.


Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes




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