Impact of prior gestational age at preterm delivery on effectiveness of 17-alpha-hydroxyprogesterone caproate in practice.

OBJECTIVE: We sought to examine if 17-alpha-hydroxyprogesterone caproate (17OHPC) effectiveness is dependent on the earliest gestational age (GA) at prior spontaneous preterm birth (SPTB) when administered in the clinical setting. STUDY DESIGN: Women enrolled for outpatient services with current singleton gestation and > or =1 prior SPTB between 20-36.9 weeks were identified. Data were divided into 3 groups according to earliest GA of prior SPTB (20-27.9, 28-33.9, and 34-36.9 weeks). We compared GA at delivery of current pregnancy and incidence of recurrent SPTB between women enrolled in outpatient 17OHPC administration program (n = 2978) and women receiving other outpatient services without 17OHPC (n = 1260). RESULTS: Rates of recurrent SPTB for those with and without 17OHPC prophylaxis, respectively, according to GA at earliest SPTB were: 20-27.9 weeks at earliest SPTB, 32.2% vs 40.7%, P = .025; 28-33.9 weeks at earliest SPTB, 34.1% vs 45.5%, P < .001; and 34-36.9 weeks at earliest SPTB, 29.3% vs 38.8%, P < .001. CONCLUSION: 17OHPC given to prevent recurrent SPTB is effective regardless of GA at earliest SPTB.

Glyburide in Women With Mild Gestational Diabetes: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether the addition of glyburide to diet therapy modifies pregnancy outcomes in women with mild gestational diabetes. METHODS: Women with at least two abnormal values on a 3-hour, 100-g oral glucose tolerance test according to National Diabetes Data Group criteria and fasting values less than 105 mg/dL between 24 and 30 weeks of gestation were randomized to blinded glyburide or placebo study drug. All women were placed on a 35-kcal/kg diet and recorded four times daily capillary glucose measurements. The study drug was titrated based on weekly maternal capillary glucose values with targets of less than 95 mg/dL (5.3 mmol/L) and 120 mg/dL (6.7 mmol/L) for fasting and 2-hour postprandial glucose measurements, respectively. The primary study outcome was a 200-g birth weight decrement in neonates of women treated with glyburide. The sample size estimate for this outcome was 334 total randomized women with a one-to-one allocation. RESULTS: A total of 395 women were enrolled at a single center between September 2008 and October 2012. Women treated with glyburide had a significantly greater decline in fasting glucose values over the course of therapy. However, there was no difference in the primary study outcome. Specifically, the mean birth weight was 33 g lower in the group treated with glyburide (P=.52). Although not powered to examine all outcomes associated with gestational diabetes, treatment with glyburide did not affect need for operative delivery, shoulder dystocia, clavicular fracture, Erb's palsy, or neonatal hypoglycemia. Four women in each group required insulin. CONCLUSION: The addition of glyburide to diet therapy significantly improved maternal glycemic control over time when compared with placebo. However, adding glyburide to diet did not decrease birth weight or improve maternal or neonatal outcomes in women with mild gestational diabetes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00744965. LEVEL OF EVIDENCE: I.

Effect of maternal body mass index on serum magnesium levels given for seizure prophylaxis.

OBJECTIVE: To estimate the effect of body mass index (BMI) on magnesium levels for eclampsia prophylaxis. METHODS: This is a retrospective study from 2004 to 2011, examining magnesium levels in women receiving seizure prophylaxis. Women received 6 g and then 2 g/h. Women had 4-hour and 12-hour levels drawn. Levels were considered subtherapeutic at less than 4.9 mg/dL, therapeutic from 4.9 to 8.4 mg/dL, and supratherapeutic at 8.5 mg/dL or more. If the 4-hour value was not therapeutic, the dose was adjusted and a 12-hour level was drawn. Levels at 4 and 12 hours were compared among the women with different BMI classifications and clinical characteristics. RESULTS: During the study period,106,265 women delivered, and 7,799 (7.4%) had preeclampsia diagnosed and received magnesium sulfate for seizure prophylaxis. A total of 5,304 (68%) of these women had a recorded BMI. At 4 hours, 2,698 (51%) were subtherapeutic. These women were more likely to be older, parous, undergo cesarean delivery, have a higher systolic blood pressure, and have central nervous system manifestations. At 12 hours, 2,342 (90%) of therapeutic women remained therapeutic, and 5% became subtherapeutic (n=118) or supratherapeutic (n=140). Using logistic regression, we were able to predict being subtherapeutic in women with greater BMI and to predict being supratherapeutic if women had labor longer than 12 hours and worsening severity of preeclampsia. CONCLUSION: Women receiving seizure prophylaxis with a BMI of more than 30 may benefit from routine serum magnesium evaluation 4 hours after the loading dose. LEVEL OF EVIDENCE: III.

Relationship of subclinical thyroid disease to the incidence of gestational diabetes.

OBJECTIVE: To estimate if there is a relationship between subclinical thyroid disease and gestational diabetes. METHODS: Between November 2000 and April 2003, serum thyrotropin screening was performed on all women who presented for prenatal care. Women identified with abnormal thyrotropin had a serum free thyroxine reflexively determined. Those women with abnormal serum free thyroxine values were referred for further evaluation and excluded from further analysis. For this analysis, normal thyrotropin values were those between the 2.5th and 97.5th percentiles (0.03-4.13 milliunits/L) not corrected for gestational age and serum free thyroxine were considered normal if they ranged from 0.9 to 2.0 mg/dL. Women with an elevated serum thyrotropin but a normal serum free thyroxine were designated to have subclinical hypothyroidism and those with a low thyrotropin and a normal serum free thyroxine level were designated to have subclinical hyperthyroidism. Euthyroid women had both normal thyrotropin and normal serum free thyroxine values. The incidence of gestational diabetes was compared among these three groups. RESULTS: Of the 24,883 women included in the study, 23,771 (95.5%) were euthyroid, 584 (2.3%) had subclinical hyperthyroidism, and 528 (2%) had subclinical hypothyroidism. The likelihood of gestational diabetes increased with thyrotropin level (P=.002). For example, when a pregnant Hispanic woman of average age and weight was used, the predicted percent of gestational diabetes increased from 1.9% to 4.9% as thyrotropin increased from 0.001 to 10 milliunits/L (P=.001). CONCLUSION: The risk of developing gestational diabetes increases with thyrotropin level. This supports a relationship between subclinical hypothyroidism and diabetes diagnosed during pregnancy. LEVEL OF EVIDENCE: III.

Intrapartum evidence of early-onset group B streptococcus.

OBJECTIVE: To estimate if neonates with early-onset group B streptococcus (GBS) sepsis have clinical evidence of fetal infection during labor or at delivery. METHODS: Retrospective cohort study of all neonates diagnosed with GBS sepsis by culture and clinical findings within the first 72 hours of life from January 1, 2000, through December 31, 2008, at Parkland Health and Hospital System. Medical records were reviewed and maternal, neonatal, and delivery data were ascertained. These neonates then were compared with all neonates delivered during the same time period. RESULTS: During the study period, 143,384 live-born neonates were delivered at our institution; 94 were diagnosed with early-onset GBS sepsis. The majority of these neonates (n=93) were diagnosed with early-onset GBS within the first hour of life. Neonates with early-onset GBS sepsis had a significant increase in preterm delivery, cesarean delivery (total and for fetal distress), 1- and 5-minute Apgar scores of 3 or lower, umbilical cord pH less than 7.0, and a base deficit of 12 mmol/L or higher. In addition, nulliparity differed between those with early-onset GBS and those without (74% compared with 33%, P<.001) as did chorioamnionitis rates (62% compared with 8%, P<.001). CONCLUSION: We believe that these findings are compelling evidence that fetuses with early-onset GBS may have signs of sepsis peripartum. We hypothesize that these data support the concept that early-onset GBS represents a spectrum of infection that often precedes birth.