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Objective To determine whether basal insulin analogs reduce the rate of composite neonatal morbidity compared with neutral protamine Hagedorn (NPH) in women with type 2 diabetes mellitus (T2DM). Study Design This was a retrospective cohort study of women with T2DM and singleton pregnancy at a single tertiary center. Primary outcome was a composite neonatal morbidity of any of the following: shoulder dystocia, large for gestational age, neonatal intensive care unit admission, neonatal hypoglycemia, or respiratory distress syndrome. Secondary outcomes were rates of maternal hypoglycemic events, hypertensive disorders, preterm birth, and primary cesarean delivery. Adjusted relative risk (aRR) and 95% confidence intervals (CI) were calculated. Results Of 233 women with T2DM that met the inclusion criteria, 114 (49%) were treated with basal insulin analogs and 119 (51%) with NPH. The rate of composite neonatal morbidity was similar between groups (73 vs. 60%; aRR: 1.18; 95% CI: 0.92–1.51). There were no differences in the rates of maternal adverse outcomes between the groups. Basal insulin analog was associated with a lower rate of primary cesarean delivery as compared with NPH (21 vs. 36%; aRR: 0.44; 95% CI: 0.25–0.78). Conclusion Among pregnant women with T2DM managed with either basal or NPH insulin regimen, the rates of composite neonatal morbidity and maternal complications were similar.

OBJECTIVE Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus (T2DM). The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM. STUDY DESIGN A pilot randomized, controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy. The primary outcome was glycemic control measured with hemoglobin A1c

Objective To compare the effectiveness of intravenous acetaminophen with that of morphine in reducing pain in the first stage of labor. Methods An open-label, randomized controlled trial of women ≥ 34 weeks gestation in the first stage of labor, assigned to either intravenous acetaminophen or morphine. The primary outcome was improved analgesia measured by difference of visual analog scale (VAS) score at 120 minutes from baseline. Secondary outcomes were request for rescue analgesia, maternal side effects, and fetal heart rate changes. Statistical analyses performed were chi-square, Student's t-test, and Kaplan-Meier survival analysis. Results Of 40 women randomized, 18 received acetaminophen (2 did not receive study drug), and 20 received morphine. Because of difficulties in recruitment, the sample size of 88 was not achieved. The primary outcome was similar between groups (p = 0.53). Within 120 minutes of initial treatment, more women receiving intravenous acetaminophen required rescue analgesia (acetaminophen: 52.9% vs. morphine: 17.6%, p Conclusion There was no difference in VAS scores between groups. However, as half of women receiving intravenous acetaminophen required rescue analgesia within 120 minutes of treatment, intravenous acetaminophen may be less effective for analgesia in early labor compared with intravenous morphine.

To compare the timing, duration, and severity of corticosteroid-associated hyperglycemia in pregnant women with and without diabetes mellitus (DM). An observational study was conducted of pregnant women with DM and controls who received corticosteroids. Median glucose levels were calculated over 4-hour intervals after the first dose of corticosteroid with a continuous glucose monitor. A glucose level increase of at least 15% above baseline was considered significant. Nine pregnant women participated in this study (six with DM and three without DM). Elevations of glucose levels occurred at hour 20, 44, and 68 in both groups and lasted for up to 4 hours. In those with DM, glucose levels increased 33 to 48%, whereas in those without DM, glucose levels rose 16 to 33%. Several, relatively short episodes of glucose elevation occur in response to corticosteroids, and are more pronounced in diabetic women.

We sought to quantify how often women with late preterm birth (LPTB) receive antenatal corticosteroid (ACS) therapy prior to 34 weeks and to determine its effects on neonatal respiratory morbidity. LPTBs (34 (0)/ (7) to 36 (6)/ (7) weeks) over a 1-year period at a single tertiary care hospital were studied. A composite neonatal respiratory outcome was defined as mechanical ventilation, continuous positive airway pressure with fraction of inspired oxygen (F IO(2))40% for2 hours or F IO(2)40% for4 hours within the first 72 hours of life. Multivariate logistic regression analysis was used to evaluate the association between ACS therapy and neonatal respiratory morbidity. Over the study period, 503 LPTBs met the study criteria and 6.8% ( N = 34) had ACS therapy34 weeks. Most had exposure7 days prior to delivery (64.7%). Almost one-half of those receiving prior ACS therapy delivered between 34 and 35 weeks. There was no difference in the rate of prior ACS therapy based on LPTB indication for delivery. After adjusting for confounding factors, prior ACS therapy was not associated with lower respiratory morbidity (odds ratio [OR] 2.0, 95% confidence interval [CI] 0.2 to 16.3, P = 0.53). Advancing gestational age was the only variable associated with respiratory morbidity (OR 0.50, 95% CI 0.26 to .94, P = 0.03). In our population, prior ACS therapy was infrequent and was not associated with improvements in neonatal respiratory morbidity following LPTB.

White's classification system (WCS) was created 60 years ago to identify diabetic (DM) pregnancies at increased risk for perinatal morbidity and mortality. Our objective was to assess the association between WCS and adverse pregnancy outcome (APO) in contemporary DM pregnancies. We studied diabetic women with singleton pregnancies who delivered at >20 weeks at a single institution over a 1-year period (2007 to 2008). Perinatal outcomes were compared between WCS groups. APO was defined as any of the following: preterm birth

We sought to determine the rate and timing of full publication of clinical trials initially presented as abstracts at a national maternal-fetal medicine (MFM) research meeting and identify factors associated with publication status. All abstracts presented over a 3-year period (2000 to 2002) at the Society of MFM Annual Meeting were reviewed. Abstracts reporting outcomes for prospective, interventional research studies with human subjects were included. Multiple electronic databases were searched for evidence of full publication with a minimum of 5-year follow-up. The reporting characteristics of abstracts that were published as full research reports were compared with those not published. During the study period, 2012 abstracts were presented and 90 met all study criteria (4.5%). Of these, 55.6% ( N = 50) were subsequently published as full research reports. There were no differences in the use of placebo, randomization, or blinding. Studies reaching full publication had larger sample size (median 174 [12 to 4165] versus 96 [22 to 1039]; P = 0.02) and were more likely to report treatment differences (60% versus 32.5% P = 0.009). After adjusting for confounding factors, the reporting of treatment differences remained associated with full publication (odds ratio 3.3 [95% confidence interval 1.3 to 8.0]; P = 0.01). Full publication of clinical trials occurred more often if treatment differences were present. Positive publication bias exists in MFM research.

The purpose of this study was to determine the frequency of prescription and over-the-counter (OTC) medications, and herbal remedies used by pregnant women. A prospective observational study was performed at a single tertiary-care hospital. Postpartum women completed a questionnaire that included a list of more than 120 medications, herbal remedies, and alternative therapies listed by both brand and common name. Patients were asked to identify any and all medications or treatments used during pregnancy. Of 418 patients who completed questionnaires, 96.9% took at least one medication during their pregnancy. After excluding prenatal vitamins and iron supplements, 76.5% took at least one other medication; 62.8% used OTC medications, and 4.1% used herbal and/or alternative remedies. Multiple drug use occurred in 33.5% of patients, with up to 13.6% consuming four or more medications. The use of prescribed and OTC, medications, and herbal/alternative therapy, is common in pregnancy, with many patients consuming more than one agent at a time.

The purpose of this study was to determine whether nucleated red blood cell (NRBC) counts are elevated in term neonates who have severe fetal acidemia at birth. The neonatal NRBC counts of term (gestational ageor = 37 weeks) neonates with pathological acidemia were compared with those from control neonates who met the following criteria: gestational ageor = 37 weeks, birth weightor = 2800 g, umbilical artery pHor = 7.25, and a 5-minute APGAR7. Pathological acidemia was defined as an umbilical artery pHor = 7.0 and a base excess-12 mEq/L. Twenty-six neonates met all inclusion criteria and were compared to 78 controls. The mean NRBC/100 WBC was 11.9 +/- 13.5 (range 0 to 45) for acidemic neonates compared to 3.9 +/- 2.9 NRBC/100 WBC (range 0 to 11) for control neonates [p0.001]. Our findings suggest that the onset of hypoxia-ischemia in pregnancies complicated by severe fetal acidemia often begins prior to the intrapartum period.

We sought to determine whether computerized physician order entry (CPOE) improves the induction agent turnaround time on the labor and delivery unit (L&D) compared with paper-based order entry (PBOE). We conducted a retrospective study of singleton, term pregnancies admitted to L&D for induction of labor. Outcomes of women who delivered 3 months before or 3 months after universal CPOE implementation were compared including induction agent turnaround time. The induction agent turnaround time was significantly shorter in the CPOE group ( N = 83) compared with PBOE group ( N = 71) [71 (range 8 to 411) versus 100 (2 to 442) minutes, P = 0.004]. There were no differences in cesarean section rate or length of hospital stay. After controlling for time of day of induction, induction agent, and type of order entry, CPOE continued to significantly decrease the induction agent turnaround time by 25 minutes ( P = 0.042). CPOE improved the process of induction of labor and efficiency of care of pregnant women.

Up to a third of preterm births follow preterm premature rupture of membranes (PPROM), but the question of whether conservative management or immediate delivery is most appropriate remains open. Frequently pulmonary maturity is estimated biochemically at 32 to 34 weeks' gestation to identify those fetuses at low risk of respiratory distress syndrome and other major disorders. Generally the absence of lung maturity is taken to warrant expectant management, but the predictive value of this assessment is not good. This study, a retrospective chart review, focused on the clinical utility of biochemical lung maturity assessment in managing PPROM at 32 to 34 weeks' gestation. Women with diabetes, hypertension, preeclampsia, or multiple gestations were excluded, as were cases of fetal growth restriction, anomalies, and clinical chorioamnionitis or positive amniotic fluid cultures. Amniotic fluid was sampled by either transabdominal amniocentesis or vaginal pool collection. Criteria for fetal lung maturity included fluorescence polarization of 55 mg/g of albumin or more, a lecithin/sphingomyelin (L:S) ratio of 3.5 or higher, and the presence of phosphatidylglycerol. Seventy-eight of 144 pregnancies complicated by PPROM during the study period (1995-2000) were eligible for the study. Amniocentesis was done in 31% of cases. There was no difference between rates of maturity indices as demonstrated in amniocentesis and vaginal pool specimens. Lung maturity was evident in 41 of 78 cases. Twenty-nine of these women were induced, all but one of them on the basis of fetal lung maturity testing. The other 12 delivered after spontaneous labor. Among cases with immature lungs, 12 of 37 were induced because of nonreassuring fetal status and 6 for other reasons. The remaining 25 patients were managed expectantly and spontaneously went into labor. Cesarean delivery was more common in patients with immature fetal lungs (27% vs. 7.3%). These infants more often were admitted to neonatal intensive care and had twice as long a hospital stay than those with mature indices (8 vs. 4 days). Major neonatal morbidity (necrotizing enterocolitis, intraventricular hemorrhage, seizures, death) was comparably frequent in the two groups. Immature fetal lungs independently predicted admission to neonatal intensive care. Lung maturity testing was 54% sensitive and 60% specific in predicting the lack of a need for mechanical ventilation. The positive and negative predictive values were 90% and 16%, respectively. Fetal lung maturity testing at 32 to 34 weeks' gestation did not predict major neonatal morbidity in this study. The investigators remain skeptical about the clinical value of such testing in patients with PPROM at this stage of gestation.