Elly Marie-Jeanne Xenakis

A comparison of glyburide and insulin in women with gestational diabetes mellitus.

BACKGROUND Women with gestational diabetes mellitus are rarely treated with a sulfonylurea drug, because of concern about teratogenicity and neonatal hypoglycemia. There is little information about the efficacy of these drugs in this group of women. METHODS We studied 404 women with singleton pregnancies and gestational diabetes that required treatment. The women were randomly assigned between 11 and 33 weeks of gestation to receive glyburide or insulin according to an intensified treatment protocol. The primary end point was achievement of the desired level of glycemic control. Secondary end points included maternal and neonatal complications. RESULTS The mean (+/-SD) pretreatment blood glucose concentration as measured at home for one week was 114+/-19 mg per deciliter (6.4+/-1.1 mmol per liter) in the glyburide group and 116+/-22 mg per deciliter (6.5+/-1.2 mmol per liter) in the insulin group (P=0.33). The mean concentrations during treatment were 105+/-16 mg per deciliter (5.9+/-0.9 mmol per liter) in the glyburide group and 105+/-18 mg per deciliter (5.9+/-1.0 mmol per liter) in the insulin group (P=0.99). Eight women in the glyburide group (4 percent) required insulin therapy. There were no significant differences between the glyburide and insulin groups in the percentage of infants who were large for gestational age (12 percent and 13 percent, respectively); who had macrosomia, defined as a birth weight of 4000 g or more (7 percent and 4 percent); who had lung complications (8 percent and 6 percent); who had hypoglycemia (9 percent and 6 percent); who were admitted to a neonatal intensive care unit (6 percent and 7 percent); or who had fetal anomalies (2 percent and 2 percent). The cord-serum insulin concentrations were similar in the two groups, and glyburide was not detected in the cord serum of any infant in the glyburide group. CONCLUSIONS In women with gestational diabetes, glyburide is a clinically effective alternative to insulin therapy.

Intensified versus conventional management of gestational diabetes

OBJECTIVE We tested the hypothesis that intensified management of gestational diabetes mellitus on the basis of stringent glycemic control, verified glucose data, and adherence to an established criterion for insulin initiation results in near normoglycemia control and reduction of adverse outcomes. STUDY DESIGN A prospective, population-based study compared the effect on perinatal outcome of conventional (n = 1316) and intensified (n = 1145) management. Group assignment was based on availability of memory-based reflectance meters at entry to the program. A contemporaneous randomized control group (nondiabetic, n = 4922) was selected. RESULTS The diabetic groups were comparable in demographic characteristics and in factors associated with higher risk for adverse pregnancy outcome, such as previous macrosomia, previous gestational diabetes mellitus, and family history of diabetes. The control group was younger, less obese, and had a lower rate of previous macrosomia. The intensified management group had rates of macrosomia, cesarean section, metabolic complications, shoulder dystocia, stillbirth, neonatal intensive care unit days, and respiratory complications lower than those in the conventional management group and comparable to those of the nondiabetic controls. Other maternal complication rates, such as for preeclampsia, chronic hypertension, and infection, were similar for the three groups. Mean blood glucose levels were a good predictor of perinatal outcome. Gestational age at delivery, previous history of macrosomia, and overall mean blood glucose levels were the only significant predictors of birth weight percentile in both diabetic groups (logistic regression). CONCLUSION The intensified management approach is significantly associated with enhanced perinatal outcome. This management strategy clarifies the relationship between glycemic control and neonatal outcome.

Do tocolytic agents stop preterm labor? A critical and comprehensive review of efficacy and safety

OBJECTIVE Our aim was to determine the efficacy and safety of tocolytic agents currently used to treat premature labor. STUDY DESIGN We carried out a comprehensive review of tocolytic agents in the treatment of premature labor. Three hundred twenty-eight studies published between 1933 and 1992 were analyzed. RESULTS An analysis of randomized, placebo-controlled, clinical trials showed that magnesium sulfate is not better than placebo in the treatment of premature labor. beta-Adrenergic receptor agonists effectively stop premature labor for only 24 to 48 hours. Calcium channel blockers and oxytocin antagonists inhibit uterine contractions, but their role in stopping labor is undefined. Prostaglandin inhibitors appear to be effective in treating premature labor and have few adverse side effects. CONCLUSIONS The only tocolytic drugs that might be effective are the prostaglandin inhibitors. Tocolytic agents should be used only between 24 and 32 completed weeks of gestation. Magnesium sulfate should not be used to treat premature labor. Oxytocin antagonists should be used only in experimental clinical trials. Calcium channel blockers and beta-adrenergic receptor agonists inhibit uterine contractions but do not prolong gestation for longer than 48 hours.

Do growth-retarded premature infants have different rates of perinatal morbidity and mortality than appropriately grown premature infants?

Objective To determine if perinatal morbidity and mortality differ in growth-retarded, small for gestational age (SGA), premature infants and appropriate for gestational age (AGA) infants. Methods All consecutive, singleton, nondiabetic, preterm pregnancies delivered over a 15-year period were analyzed. Infants were categorized as SGA (at or below the tenth percentile) or AGA (11th to the 89th percentiles), then stratified by birth weight and gestational age categories. Perinatal morbidity and mortality were examined. Results We studied 4183 preterm deliveries, 1012 of them SGA and 3171 of them AGA. Overall, we found significantly higher rates of fetal and neonatal death in the SGA group. Stratification by gestational age revealed significantly higher rates of neonatal death for the SGA group compared with the AGA group in each gestational age category. Overall, comparison also revealed significantly higher rates of fetal heart rate abnormality in the SGA group but no difference in neonatal sepsis, birth trauma, cesarean delivery, hyaline membrance disease, or congenital anomalies. Conclusion Growth-retarded premature infants have a significantly higher risk of morbidity and mortality, both before and after delivery, than do appropriately grown infants.

Induction of labor in the nineties : Conquering the unfavorable cervix

Objective To determine the efficacy, safety, and duration of induced labor using an integrative approach (prostaglandin, amniotomy, oxytocin) and to depict these findings graphically. Methods Five hundred ninety-seven pregnancies requiring induction of labor between October 1993 and May 1995 were analyzed prospectively. Patients were categorized by Bishop score at entry and by parity for comparison of success of induction, maternal and fetal complications, and duration of labor. Results The women who had a Bishop score at entry of 3 or less had significantly higher rates of failed induction (9.4 versus 0.7%, P < .01) and of cesarean delivery (29 versus 15.4%, P < .01) than those with a Bishop score above 3. Compared with spontaneous labor, the rates of cesarean delivery in induced labor remained significantly elevated. Complications of induction were infrequent, regardless of Bishop score. The time from initiation of induction to achievement of active phase was significantly longer in women with lower Bishop scores. Conclusion Regardless of cervical status and parity, vaginal delivery can be anticipated in the majority of patients undergoing labor induction. The induction characteristics described may assist in the management of induced labor.

Are labor abnormalities more common in shoulder dystocia

OBJECTIVE Our objective was to determine the association between labor abnormalities and shoulder dystocia. STUDY DESIGN All consecutive cases of shoulder dystocia from January 1986 to August 1994 were reviewed (n = 276). For purposes of comparison a control group of vaginally delivered patients was randomly selected in a 2:1 ratio (n = 600). Charts were reviewed for demographic information, labor and delivery events, and neonatal outcome. RESULTS Labor abnormalities were comparable in the shoulder dystocia and control groups, both in the active phase and in the second stage. When patients with diabetes and those with macrosomic infants were analyzed separately, no significant differences in labor abnormalities were identified. The rate of operative vaginal delivery was significantly higher in the shoulder group, and one third of the operative deliveries were midpelvic. In addition, the induction rate was higher in the shoulder group. CONCLUSIONS Our data suggest that labor abnormalities may not serve as clinical predictors for subsequent development of shoulder dystocia, thus emphasizing the unpredictability of this condition.

Low-dose versus high-dose oxytocin augmentation of labor — A randomized trial

OBJECTIVE Our purpose was to compare the efficacy and safety of low-dose versus high-dose oxytocin regimens in the augmentation of labor. STUDY DESIGN Three hundred ten term pregnancies requiring augmentation of labor underwent randomization to receive either a low-dose or high-dose oxytocin augmentation regimen. Maternal demographics, labor-delivery data, and neonatal outcome were compared. RESULTS The high-dose oxytocin group had a significantly lower cesarean section rate, regardless of parity (10.4% vs 25.7%, p < 0.001), with no differences in maternal complications and neonatal outcomes. The time needed to correct the labor abnormality was also significantly decreased (1.24 +/- 1.4 hours vs 3.12 +/- 1.6 hours, p < 0.001) in the high-dose group. CONCLUSIONS The use of high-dose oxytocin regimen benefits both nulliparous and multiparous women requiring labor augmentation by significantly lowering both the time necessary to correct the labor abnormality and the need for cesarean section.

The use of laparoscopic surgery in pregnancy: evaluation of safety and efficacy

BACKGROUND Laparoscopic surgery in pregnant women has become increasingly more common since the 1990s; however, the safety of laparoscopy in this population has been widely debated, particularly in emergent and urgent situations. METHODS A retrospective chart review of all pregnant women following a nonobstetric abdominal operation at a University hospital between 1993 and 2007. Perioperative morbidity and mortality for the mother and fetus were evaluated. RESULTS Ninety-four subjects were identified; 53 underwent laparoscopic procedures and 41 underwent open procedures. Cholecystectomy and appendectomy were performed in both groups with salpingectomy/ovarian cystectomy only in the laparoscopic group. No maternal deaths occurred, while fetal loss occurred in 3 cases within 7 days of the operation and in 1 case 7 weeks postoperatively. This and other perinatal complications occurred in 36.7% of the laparoscopic group and 41.7% of the open group. CONCLUSION Laparoscopic appendectomy and cholecystectomy appear to be as safe as the respective open procedures in pregnant patients; however, this population in particular remains at risk for perinatal complications regardless of the method of abdominal access.

Glucose screening in Mexican-American women.

OBJECTIVE: We sought to describe the predictive value for gestational diabetes mellitus (GDM) using different glucose challenge test thresholds in Mexican-American women. METHODS: A prospective population-based study of 6,857 gravid women, who were tested with a 50-g glucose challenge test at 24–28 weeks of gestation, was performed. A screening value of 130 mg/dL or greater was followed by a 3-hour, 100-g oral glucose tolerance test. Gestational diabetes mellitus was diagnosed by 2 or more abnormal values using the Carpenter and Coustan criteria. For purpose of analysis, GDM diagnosis was categorized with glucose challenge test values in 10-mg/dL increments. A comparison between Carpenter-Coustan and the National Diabetic Data Group criteria for GDM diagnosis was performed for each glucose challenge test threshold category. Sensitivity and specificity for GDM diagnosis were further calculated for different glucose challenge test thresholds (130, 135, and 140 mg/dL). RESULTS: Overall, GDM was diagnosed in 469 of 6,857 (6.8%) women, and one abnormal oral glucose tolerance test value was tested in 351 of 6,857 women (5.1%). Normal glucose challenge test results (threshold less than 130 mg/dL) were obtained in 4,316 of 6,857 women. An elevated glucose challenge test value increases the risk of GDM, but even in high glucose challenge test thresholds (more than 180 mg/dL), the predictive value for GDM was only 50%. The sensitivity and specificity for GDM diagnosis using 3 different glucose challenge test thresholds were as follows: threshold 130 mg/dL or more: 97% and 63%; threshold 135 mg/dL or more: 91% and 73%; and threshold 140 mg/dL or more: 85% and 78%, respectively. CONCLUSION: Data suggests that an elevated glucose challenge test level cannot be used as a single diagnostic tool for GDM even in high test thresholds. A threshold of 130 mg/dL may be recommended as a screening threshold for GDM in Mexican-American women. LEVEL OF EVIDENCE: II-3

Is fetal heart rate variability a good predictor of fetal outcome

Objective. The purpose of this study was to investigate, in a prospective manner, whether fetal heart rate (FHR) variability serves as a reliable single predictor of fetal outcome.