John M Thorp

University of North Carolina at Chapel Hill, North Carolina, United States

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Publications (289)1611.76 Total impact

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    ABSTRACT: Objective The aim of the study is to evaluate the association of steroid metabolism and respiratory gene polymorphisms in neonates exposed to antenatal corticosteroids (ACS) with respiratory outcomes, small for gestational age (SGA), and response to repeat ACS. Study Design This candidate gene study is a secondary analysis of women enrolled in a randomized controlled trial of single versus weekly courses of ACS. Nineteen single nucleotide polymorphisms (SNPs) in 13 steroid metabolism and respiratory function genes were evaluated. DNA was extracted from placenta or fetal cord serum and analyzed with TaqMan genotyping. Each SNP was evaluated for association via logistic regression with respiratory distress syndrome (RDS), continuous positive airway pressure (CPAP)/ventilator use (CPV), and SGA. Results CRHBP, CRH, and CRHR1 minor alleles were associated with an increased risk of SGA. HSD11B1 and SCNN1B minor alleles were associated with an increased likelihood of RDS. Carriage of minor alleles in SerpinA6 was associated with an increased risk of CPV. CRH and CRHR1 minor alleles were associated with a decreased likelihood of CPV. Conclusion Steroid metabolism and respiratory gene SNPs are associated with respiratory outcomes and SGA in patients exposed to ACS. Risks for respiratory outcomes are affected by minor allele carriage as well as by treatment with multiple ACS.
    American Journal of Perinatology 10/2015; 32(12):1126-1132. DOI:10.1055/s-0035-1549217 · 1.91 Impact Factor
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    ABSTRACT: Objective To determine the risk of gestational diabetes mellitus (GDM) and insulin resistance (IR) in obesity defined by body mass index (BMI), waist-to-hip ratio (WHR), or both combined. Methods Secondary analysis of a randomized multicenter trial of antioxidant supplementation versus placebo in nulliparous low-risk women to prevent pregnancy associated hypertension. Women between 9 and 16 weeks with data for WHR and BMI were analyzed for GDM (n = 2,300). Those with fasting glucose and insulin between 22 and 26 weeks (n = 717) were analyzed for IR by homeostatic model assessment of IR (normal, ≤ 75th percentile). WHR and BMI were categorized as normal (WHR, < 0.80; BMI, < 25 kg/m(2)); overweight (WHR, 0.8-0.84; BMI, 25-29.9 kg/m(2)); and obese (WHR, ≥ 0.85; BMI ≥ 30 kg/m(2)). Receiver operating characteristic curves and logistic regression models were used. Results Compared with normal, the risks of GDM or IR were higher in obese by BMI or WHR. The subgroup with obesity by WHR but not by BMI had no increased risk of GDM. BMI was a better predictor of IR (area under the curve [AUC]: 0.71 [BMI], 0.65 [WHR], p = 0.03) but similar to WHR for GDM (AUC: 0.68 [BMI], 0.63 [WHR], p = 0.18). Conclusion Increased WHR and BMI in early pregnancy are associated with IR and GDM. BMI is a better predictor of IR compared with WHR. Adding WHR to BMI does not improve its ability to detect GDM or IR.
    American Journal of Perinatology 09/2015; DOI:10.1055/s-0035-1562928 · 1.91 Impact Factor

  • Obstetric Anesthesia Digest 09/2015; 35(3):153-154. DOI:10.1097/01.aoa.0000469490.12751.44
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    ABSTRACT: It is unclear whether using fetal electrocardiographic (ECG) ST-segment analysis as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring modifies intrapartum and neonatal outcomes. We performed a multicenter trial in which women with a singleton fetus who were attempting vaginal delivery at more than 36 weeks of gestation and who had cervical dilation of 2 to 7 cm were randomly assigned to "open" or "masked" monitoring with fetal ST-segment analysis. The masked system functioned as a normal fetal heart-rate monitor. The open system displayed additional information for use when uncertain fetal heart-rate patterns were detected. The primary outcome was a composite of intrapartum fetal death, neonatal death, an Apgar score of 3 or less at 5 minutes, neonatal seizure, an umbilical-artery blood pH of 7.05 or less with a base deficit of 12 mmol per liter or more, intubation for ventilation at delivery, or neonatal encephalopathy. A total of 11,108 patients underwent randomization; 5532 were assigned to the open group, and 5576 to the masked group. The primary outcome occurred in 52 fetuses or neonates of women in the open group (0.9%) and 40 fetuses or neonates of women in the masked group (0.7%) (relative risk, 1.31; 95% confidence interval, 0.87 to 1.98; P=0.20). Among the individual components of the primary outcome, only the frequency of a 5-minute Apgar score of 3 or less differed significantly between neonates of women in the open group and those in the masked group (0.3% vs. 0.1%, P=0.02). There were no significant between-group differences in the rate of cesarean delivery (16.9% and 16.2%, respectively; P=0.30) or any operative delivery (22.8% and 22.0%, respectively; P=0.31). Adverse events were rare and occurred with similar frequency in the two groups. Fetal ECG ST-segment analysis used as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring did not improve perinatal outcomes or decrease operative-delivery rates. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Neoventa Medical; number, NCT01131260.).
    New England Journal of Medicine 08/2015; 373(7):632-41. DOI:10.1056/NEJMoa1500600 · 55.87 Impact Factor
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    ABSTRACT: To evaluate the relationship of maternal antenatal magnesium sulfate (MgSO4) with neonatal cranial ultrasound abnormalities and cerebral palsy (CP). In a randomized trial of MgSO4 or placebo in women at high risk of preterm delivery, up to 3 cranial ultrasounds were obtained in the neonatal period. Images were reviewed by at least 2 pediatric radiologists masked to treatment and other clinical conditions. Diagnoses were predefined for intraventricular hemorrhage, periventricular leukomalacia, intracerebral echolucency or echodensity, and ventriculomegaly. CP was diagnosed at 2 years of age by standardized neurologic examination. Intraventricular hemorrhage, periventricular leukomalacia, intracerebral echolucency or echodensity, and ventriculomegaly were all strongly associated with an increased risk of CP. MgSO4 administration did not affect the risk of cranial ultrasound abnormality observed at 35 weeks postmenstrual age or later. However, for the 82% of infants born at <32 weeks gestation, MgSO4 was associated with a reduction in risk of echolucency or echodensity. The reduction in risk for echolucency explained 21% of the effect of MgSO4 on CP (P = .04), and for echodensity explained 20% of the effect (P = .02). MgSO4 given prior to preterm delivery was associated with decreased risk of developing echodensities and echolucencies at <32 weeks gestation. However, this effect can only partially explain the effect of MgSO4 on CP at 2 years of age. NCT00014989. Published by Elsevier Inc.
    The Journal of pediatrics 08/2015; DOI:10.1016/j.jpeds.2015.06.067 · 3.79 Impact Factor
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    ABSTRACT: To describe the prevalence of serious maternal complications following early preterm birth by gestational age (GA), delivery route and type of cesarean incision. Trained personnel abstracted data from maternal and neonatal charts for all deliveries on randomly selected days representing 1/3 of deliveries across 25 US hospitals over 3 years (n=115,502). All women delivering non-anomalous singletons between 23 and 33 weeks' gestation were included. Women were excluded for antepartum stillbirth and highly morbid conditions for which route of delivery would not likely impact morbidity including non-reassuring fetal status, cord prolapse, placenta previa, placenta accreta, placental abruption, and severe, unstable maternal conditions (cardiopulmonary collapse, acute respiratory distress syndrome, seizures). Serious maternal complications were defined as: hemorrhage (blood loss ≥1500 mL, blood transfusion, or hysterectomy for hemorrhage); infection (endometritis, wound dehiscence, or wound infection requiring antibiotics, reopening or unexpected procedure); ICU admission; or death. Delivery route was categorized as classical cesarean delivery (CCD), low transverse cesarean delivery (LTCD), low vertical cesarean delivery (LVCD), and vaginal delivery (VD). Association of delivery route with complications was estimated using multivariable regression models yielding adjusted relative risks (aRR) controlling for maternal age, race, body mass index, hypertension, diabetes, preterm premature rupture of membranes , preterm labor, GA, and hospital of delivery. Of 2659 women who met criteria for inclusion in this analysis, 8.6% of women experienced serious maternal complications. Complications were associated with GA and were highest between 23-27 weeks of gestation. The frequency of complications was associated with delivery route; compared with 3.5% of SVD, 23.0% of CCD (aRR 3.54, 95%CI 2.29-5.48), 12.1% of LTCD (aRR 2.59, 95%CI 1.77-3.77), and 10.3% of LVCD (aRR 2.27, 95%CI 0.68-7.55) experienced complications. There was no significant difference in complication rates between CCD and LTCD (aRR 1.37, 95%CI 0.95-1.97) or between CCD and LVCD (aRR 1.56, 95%CI 0.48-5.07). The risk of maternal complications after early preterm delivery is substantial, particularly in women who undergo cesarean delivery. Obstetricians need to be prepared to manage potential hemorrhage, infection and ICU admission for early preterm births requiring cesarean delivery. Copyright © 2015 Elsevier Inc. All rights reserved.
    American journal of obstetrics and gynecology 07/2015; DOI:10.1016/j.ajog.2015.06.064 · 4.70 Impact Factor
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    ABSTRACT: To examine the association between gestational age (GA) at the time of treatment initiation for gestational diabetes (GDM) and maternal and perinatal outcomes. A secondary analysis of a multicenter randomized treatment trial of mild GDM in which women with mild GDM were randomized to treatment versus usual care. The primary outcome of the original trial, as well as this analysis, was a composite perinatal adverse outcome that included neonatal hypoglycemia, hyperbilirubinemia, hyperinsulinemia, and perinatal mortality. Other outcomes examined included the frequency of large for gestational age (LGA), birth weight, neonatal intensive care unit admission (NICU), gestational hypertension / preeclampsia and cesarean delivery. The interaction between GA at treatment initiation (stratified as 24-26 weeks, 27 weeks, 28 weeks, 29 weeks, ≥30 weeks) and treatment group (treated vs. routine care), with the outcomes of interest, was used to determine whether GA at treatment initiation was associated with outcome differences. Of 958 women analyzed, those who initiated treatment at an earlier GA did not gain an additional treatment benefit compared to those who initiated treatment at a later GA (p-value for interaction with the primary outcome is 0.44). Similarly, there was no evidence that other outcomes were significantly improved by earlier initiation of GDM treatment (LGA p=0.76; NICU admission p=0.8; cesarean delivery p=0.82). The only outcome that had a significant interaction between GA and treatment was gestational hypertension/preeclampsia (p=0.04), although there was not a clear cut GA trend where this outcome improved with treatment. Earlier initiation of treatment of mild GDM was not associated with stronger effect of treatment on perinatal outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.
    American journal of obstetrics and gynecology 06/2015; DOI:10.1016/j.ajog.2015.06.022 · 4.70 Impact Factor
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    Obstetric Anesthesia Digest 06/2015; 35(2):58-59. DOI:10.1097/01.aoa.0000463802.46868.ed
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    ABSTRACT: To evaluate whether the presence of condition-specific obstetric protocols within a hospital was associated with better maternal and neonatal outcomes. Cohort study of a random sample of deliveries performed at 25 hospitals over three years. Condition-specific protocols were collected from all hospitals and categorized independently by two authors. Data on maternal and neonatal outcomes, as well as data necessary for risk adjustment were collected. Risk-adjusted outcomes were compared according to whether the patient delivered in a hospital with condition-specific obstetric protocols at the time of delivery. Hemorrhage-specific protocols were not associated with a lower rate of postpartum hemorrhage or with fewer cases of EBL >1000cc. Similarly, in the presence of a shoulder dystocia protocol, there were no differences in the frequency of shoulder dystocia or number of shoulder dystocia maneuvers used. Conversely, preeclampsia-specific protocols were associated with fewer ICU admissions (OR 0.28, 95% CI 0.18-0.44) and fewer cases of severe maternal hypertension (OR 0.86, 95% CI 0.77-0.96). The presence of condition-specific obstetric protocols was not consistently shown to be associated with improved risk-adjusted outcomes. Our study would suggest that the presence or absence of a protocol does not matter and regulations to require protocols are not fruitful. Copyright © 2015 Elsevier Inc. All rights reserved.
    American Journal of Obstetrics and Gynecology 02/2015; 213(1). DOI:10.1016/j.ajog.2015.01.055 · 4.70 Impact Factor

  • Journal of Allergy and Clinical Immunology 02/2015; 135(2):AB1. DOI:10.1016/j.jaci.2014.12.936 · 11.48 Impact Factor
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    ABSTRACT: To compare neonatal abstinence syndrome prevalence and characteristics among neonates born to women prescribed buprenorphine and naloxone compared with methadone during pregnancy. Retrospective cohort analysis of mother-neonate dyads treated with either buprenorphine and naloxone or methadone during pregnancy. Primary neonatal outcomes included diagnosis of neonatal abstinence syndrome, neonatal abstinence syndrome peak scores, total amount of morphine used to treat neonatal abstinence syndrome (mg), and duration of treatment for neonatal abstinence syndrome (days). Secondary outcomes included head circumference, birth weight, length, preterm birth, neonatal intensive care unit admission, Apgar scores, and overall length of hospitalization. From January 1, 2011, to November 30, 2013, we identified 62 mother-neonate dyads, 31 treated with methadone and 31 treated with buprenorphine and naloxone. Sixteen neonates (51.6%) in the methadone group were diagnosed with neonatal abstinence syndrome compared with eight (25.1%) in the buprenorphine and naloxone group (adjusted odds ratio 2.55, 95% confidence interval [CI] 1.31-4.98, P=.01). The buprenorphine and naloxone-exposed neonates had lower peak neonatal abstinence syndrome scores (9.0±4.4 compared with 10.7±3.7, multivariate-adjusted mean difference=-2.77, 95% CI -4.99 to -0.56, P=.02) and shorter overall hospitalization (5.6±5.0 compared with 9.8±7.4 days, multivariate-adjusted mean difference=-3.90, 95% CI, -7.13 to -0.67, P=.02). We found no other differences in primary or secondary outcomes. In a cohort of pregnant patients treated with either methadone or buprenorphine and naloxone in pregnancy, newborns exposed to maternal buprenorphine and naloxone had less frequent neonatal abstinence syndrome. Additionally, neonates exposed to buprenorphine and naloxone had shorter overall hospitalization lengths. LEVEL OF EVIDENCE:: II.
    Obstetrics and Gynecology 01/2015; 125(2). DOI:10.1097/AOG.0000000000000640 · 5.18 Impact Factor
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    ABSTRACT: Objective: The aim of the article is to determine whether maternal body mass index (BMI) influences the beneficial effects of diabetes treatment in women with gestational diabetes mellitus (GDM). Study design: Secondary analysis of a multicenter randomized treatment trial of women with GDM. Outcomes of interest were elevated umbilical cord c-peptide levels (> 90th percentile 1.77 ng/mL), large for gestational age (LGA) birth weight (> 90th percentile), and neonatal fat mass (g). Women were grouped into five BMI categories adapted from the World Health Organization International Classification of normal, overweight, and obese adults. Outcomes were analyzed according to treatment group assignment. Results: A total of 958 women were enrolled (485 treated and 473 controls). Maternal BMI at enrollment was not related to umbilical cord c-peptide levels. However, treatment of women in the overweight, Class I, and Class II obese categories was associated with a reduction in both LGA birth weight and neonatal fat mass. Neither measure of excess fetal growth was reduced with treatment in normal weight (BMI < 25 kg/m(2)) or Class III (BMI ≥ 40 kg/m(2)) obese women. Conclusion: There was a beneficial effect of treatment on fetal growth in women with mild GDM who were overweight or Class I and Class II obese. These effects were not apparent for normal weight and very obese women.
    American Journal of Perinatology 12/2014; 32(01):093-100. DOI:10.1055/s-0034-1374815 · 1.91 Impact Factor
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    ABSTRACT: To evaluate the accuracy of sonographic classification of chorionicity in a large cohort of twins and investigate which factors may be associated with sonographic accuracy. We conducted a secondary analysis of a randomized trial of preterm birth prevention in twins. Sonographic classification of chorionicity was compared with pathologic examination of the placenta. Maternal (age, body mass index, diabetes, and hypertension), obstetric (prior cesarean delivery, gestational age at the first sonographic examination, and antepartum bleeding), and sonographic (oligohydramnios, polyhydramnios, and twin-twin transfusion syndrome) factors were assessed for their possible association with accuracy. A total of 545 twin sets in which chorionicity was classified by sonography before 20 weeks' gestation were included; 455 were dichorionic and 90 were monochorionic based on pathologic examination. Sonography misclassified 35 of 545 twin pregnancies (6.4%): 18 of 455 dichorionic twins (4.0%) and 17 of 90 monochorionic twins (19.0%). The sensitivity and specificity of sonographic diagnosis of monochorionicity were 81.1% and 96.0%, respectively. In a multivariable analysis, pregnancies with initial sonographic examinations before 14 weeks' gestation were less likely to have misclassified chorionicity than those with sonographic examinations at 15 to 20 weeks (odds ratio [OR], 0.47; 95% confidence interval [CI], 0.23-0.96). For each week increase in gestational age, the odds of misclassification rose by 10% (OR, 1.10; 95% CI, 1.01-1.2). In the multivariable analysis, maternal age, body mass index, parity, and prior cesarean delivery were not associated with sonographic accuracy. Sonography before 20 weeks incorrectly classified chorionicity in 6.4% of twin gestations. Those with first sonographic examinations performed at earlier gestational ages had improved chorionicity diagnosis. © 2013 by the American Institute of Ultrasound in Medicine.
    Journal of ultrasound in medicine: official journal of the American Institute of Ultrasound in Medicine 12/2014; 33(12):2187-92. DOI:10.7863/ultra.33.12.2187 · 1.54 Impact Factor
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    ABSTRACT: Objective Smoking and pre-eclampsia (PE) are associated with increases in preterm birth, placental abruption and low birthweight. We evaluated the relationship between prenatal vitamin C and E (C/E) supplementation and perinatal outcomes by maternal self-reported smoking status focusing on outcomes known to be impacted by maternal smoking.Design/Setting/PopulationA secondary analysis of a multi-centre trial of vitamin C/E supplementation starting at 9–16 weeks in low-risk nulliparous women with singleton gestations.Methods We examined the effect of vitamin C/E by smoking status at randomisation using the Breslow–Day test for interaction.Main outcome measuresThe trial's primary outcomes were PE and a composite outcome of pregnancy-associated hypertension (PAH) with serious adverse outcomes. Perinatal outcomes included preterm birth and abruption.ResultsThere were no differences in baseline characteristics within subgroups (smokers versus nonsmokers) by vitamin supplementation status. The effect of prenatal vitamin C/E on the risk of PE (P = 0.66) or PAH composite outcome (P = 0.86) did not differ by smoking status. Vitamin C/E was protective for placental abruption in smokers (relative risk [RR] 0.09; 95% CI 0.00–0.87], but not in nonsmokers (RR 0.92; 95% CI 0.52–1.62) (P = 0.01), and for preterm birth in smokers (RR 0.76; 95% CI 0.58–0.99) but not in nonsmokers (RR 1.03; 95% CI 0.90–1.17) (P = 0.046).Conclusion In this cohort of women, smoking was not associated with a reduction in PE or the composite outcome of PAH. Vitamin C/E supplementation appears to be associated with a reduction in placental abruption and preterm birth among smokers.
    BJOG An International Journal of Obstetrics & Gynaecology 12/2014; 122(13). DOI:10.1111/1471-0528.13201 · 3.45 Impact Factor
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    ABSTRACT: To evaluate whether treatment of mild gestational diabetes mellitus (GDM) confers sustained offspring health benefits, including a lower frequency of obesity. Follow-up study of children (ages 5-10) of women enrolled in a multicenter trial of treatment versus no treatment of mild GDM. Height, weight, blood pressure, waist circumference, fasting glucose, fasting insulin, triglycerides, and HDL cholesterol were measured. Five hundred of 905 eligible offspring (55%) were enrolled. Maternal baseline characteristics were similar between the follow-up treated and untreated groups. The frequencies of BMI ≥95th (20.8% and 22.9%) and 85th (32.6% and 38.6%) percentiles were not significantly different in treated versus untreated offspring (P = 0.69 and P = 0.26). No associations were observed for BMI z score, log waist circumference, log triglycerides, HDL cholesterol, blood pressure, or log HOMA estimated insulin resistance (HOMA-IR). The effect of treatment was different by sex for fasting glucose and log HOMA-IR (P for interaction = 0.002 and 0.02, respectively) but not by age-group (5-6 and 7-10 years) for any outcomes. Female offspring of treated women had significantly lower fasting glucose levels. Although treatment for mild GDM has been associated with neonatal benefits, no reduction in childhood obesity or metabolic dysfunction in the offspring of treated women was found. However only female offspring of women treated for mild GDM had lower fasting glucose. © 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.
    Diabetes Care 11/2014; 38(3). DOI:10.2337/dc14-2159 · 8.42 Impact Factor
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    ABSTRACT: Many behaviors and substances have been purported to induce labor. Using data from the Third Pregnancy, Infection, and Nutrition cohort, we focus on 663 women who experienced spontaneous labor. Of the women who reported a specific labor trigger, 32% reported physical activity (usually walking), 24% a clinician-mediated trigger, 19% a natural phenomenon, 14% some other physical trigger (including sexual activity), 12% reported ingesting something, 12% an emotional trigger, and 7% maternal illness. With the exceptions of walking and sexual intercourse, few women reported any one specific trigger, although various foods/substances were listed in the “ingesting something” category. Discussion of potential risks associated with “old wives’ tale” ways to induce labor may be warranted as women approach term.
    Journal of Perinatal Education 11/2014; 23(3). DOI:10.1891/1058-1243.23.3.155
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    ABSTRACT: To estimate the frequency of abnormal laboratory test results in pregnancy-associated hypertension and the relationship with pregnancy outcomes. This was a secondary analysis of a multicenter trial of vitamin C and E for prevention of pregnancy-associated hypertension in low-risk nulliparous women. Laboratory abnormalities included: platelets less than 100,000/mm, aspartate aminotransferase 100 units/L or greater, creatinine 1.5 mg/dL or greater, lactate dehydrogenase 600 units/L or greater, total bilirubin 1.2 mg/dL or greater, or evidence of hemolysis on peripheral smear. Mild pregnancy-associated hypertension was defined as blood pressure 140-159/90-109 mm Hg. Severe pregnancy-associated hypertension was defined as persistent blood pressure 160/110 mm Hg or greater, acute antihypertensive treatment, or any blood pressure elevation associated with clinical signs of end-organ dysfunction (one or more of headache, epigastric pain, blurred vision, pulmonary edema, eclampsia, or oliguria). Pregnancy outcomes were compared across four groups: I, mild hypertension alone; II, mild hypertension+abnormal laboratory values; III, severe pregnancy-associated hypertension alone; and IV, severe pregnancy-associated hypertension+abnormal laboratory values. Of 9,969 women, 2,752 (27.9%) developed pregnancy-associated hypertension and of these, laboratory abnormalities occurred in 7.3%. Laboratory abnormalities increased with severity of hypertension: mild hypertension alone (4.9%), severe hypertension alone (8.9%), and mild or severe hypertension with clinical signs of end-organ dysfunction (12.2%) (P for trend<.001). Compared with women with mild hypertension alone, the adjusted odds for the perinatal composite (2-fold to 4.8-fold in Category III-IV), preterm birth (2.1-fold to 7.8-fold in Category II-IV), and other adverse perinatal outcomes increase with disease severity, particularly with laboratory abnormalities and severe clinical signs. The frequency of abnormal laboratory values in women with pregnancy-associated hypertension increases with disease severity. Adverse perinatal outcomes increase in the presence of abnormal laboratory values, particularly in those with clinical signs, likely atttributable in part to the decision to deliver early. : II.
    Obstetrics and Gynecology 11/2014; 124(5):933-40. DOI:10.1097/AOG.0000000000000509 · 5.18 Impact Factor
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    ABSTRACT: For many asthma medications, pregnancy safety data remains insufficient. The omalizumab pregnancy registry, EXPECT, evaluates maternal, pregnancy, and infant outcomes after exposure to omalizumab, including incidence of congenital anomalies. EXPECT is a prospective, observational study of pregnant women exposed to ≥1 dose of omalizumab within 8 weeks prior to conception or at any time during pregnancy. Primary outcome measures include rates of live births, elective terminations, stillbirths, and congenital anomalies. Data were collected at enrollment, each trimester, birth, and every 6 months up to 18 months post-delivery. As of November 2012, 188 of 191 pregnant women were exposed to omalizumab during their first trimester. Of 169 pregnancies with known outcomes (median exposure during pregnancy, 8.8 months), there were 156 live births of 160 infants (4 twin pairs), 1 fetal death/stillbirth, 11 spontaneous abortions, and 1 elective termination. Among 152 singleton infants, 22 (14.5%) were born prematurely. Of 147 singleton infants with weight data, 16 (10.9%) were small for gestational age. Among 125 singleton full-term infants, 4 (3.2%) had low birth weights. Overall, 20 infants had congenital anomalies confirmed, 7 (4.4%) of whom had 1 major defect. No pattern of anomalies was observed. To date, proportions of major congenital anomalies, prematurity, low birth weight, and small size for gestational age observed in the EXPECT registry are not inconsistent with findings from other studies in this asthma population. Recognizing the small sample size available, no apparent increased birth prevalence of major anomalies or patterns of major anomalies has been observed. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
    Journal of Allergy and Clinical Immunology 10/2014; 135(2). DOI:10.1016/j.jaci.2014.08.025 · 11.48 Impact Factor
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    ABSTRACT: Objective: This study aims to evaluate whether magnesium sulfate administration for neuroprotection prolongs latency in women with preterm premature rupture of membranes (PPROM) between 24 and 31(6/7) weeks' gestation. Study design: This is a secondary analysis of a randomized controlled trial of magnesium sulfate for prevention of cerebral palsy. Gravid women with a singleton pregnancy between 24 and 31(6/7) weeks' gestation with PPROM without evidence of labor were randomized to receive magnesium sulfate, administered intravenously as a 6-g bolus followed by a constant infusion of 2 g per hour up to 12 hours, or placebo. Maternal outcomes for this analysis were delivery in less than 48 hours and in less than 7 days from randomization. Neonatal outcomes included a composite of respiratory distress syndrome, interventricular hemorrhage grades 3 or 4, periventricular leukomalacia, sepsis, necrotizing enterocolitis, retinopathy of prematurity, or death. Results: A total of 1,259 women were included. The rate of delivery < 48 hours was not different in the magnesium sulfate and the placebo groups (22.2 and 20.7%, p = 0.51). Delivery < 7 days was similar between groups (55.4 and 51.4%, p = 0.16). Median latency was also similar between groups (median [interquartile range], 6.0 days [range, 2.4-13.8 days] and 6.6 days [range, 2.4-15.1 days], p = 0.29). Composite neonatal outcomes did not differ between groups. Conclusion: Magnesium sulfate administration given for neuroprotection in women with a singleton gestation with PPROM and without labor before 32 weeks does not impact latency.
    American Journal of Perinatology 09/2014; 32(04). DOI:10.1055/s-0034-1387930 · 1.91 Impact Factor
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    ABSTRACT: Objective: To test whether elevated umbilical cord serum inflammatory cytokine levels predicted subsequent cerebral palsy (CP) or neurodevelopmental delay (NDD). Study design: Nested case-control analysis within a clinical trial of antenatal magnesium sulfate (MgSO4) before anticipated preterm birth (PTB) for prevention of CP, with evaluation of surviving children at the age of 2. NDD was defined as a Bayley psychomotor developmental index (PDI) and/or mental developmental index (MDI) < 70. Controls, defined as surviving children without CP and with Bayley PDI and MDI ≥ 85, were matched by race and gestational age. Cord serum was analyzed for interleukin-8 (IL-8) interleukin-1 beta (IL-1β), and tumor necrosis factor-α (TNF-α) levels. Elevated cytokine levels were defined as ≥ 75th percentile in placebo-exposed controls. Analyses compared case/control cytokine levels, adjusting for MgSO4 exposure, gestational age, race/ethnicity, and sociodemographic differences. Results: Logistic regression analysis with 339 cases and 276 controls showed that elevated IL-8 and IL-1β were more common in cord blood serum from infants with subsequent low MDI as compared with controls. After adjusting for additional confounders, the significant differences were no longer evident. Cytokine levels (IL-8, IL-1β, and TNF-α) were not elevated with CP or low PDI. Conclusion: Cord serum IL-8, IL-1β, and TNF-α levels in preterm infants are not associated with subsequent CP or NDD.
    American Journal of Perinatology 06/2014; 30(02). DOI:10.1055/s-0034-1376185 · 1.91 Impact Factor

Publication Stats

9k Citations
1,611.76 Total Impact Points


  • 1989-2015
    • University of North Carolina at Chapel Hill
      • • Department of Obstetrics and Gynecology
      • • Department of Epidemiology
      North Carolina, United States
  • 2003-2014
    • Columbia University
      • Department of Obstetrics and Gynecology
      New York, New York, United States
  • 2006-2013
    • George Washington University
      Washington, Washington, D.C., United States
    • University of California, San Francisco
      • Department of Obstetrics, Gynecology and Reproductive Sciences
      San Francisco, California, United States
  • 2010-2012
    • Drexel University
      Filadelfia, Pennsylvania, United States
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development
      Maryland, United States
    • University of Texas Health Science Center at Houston
      • Department of Obstetrics, Gynecology and Reproductive Sciences
      Houston, Texas, United States
  • 2011
    • University of Tennessee
      • Department of Obstetrics and Gynecology
      Knoxville, Tennessee, United States
    • Nationwide Children's Hospital
      Columbus, Ohio, United States
  • 2004-2011
    • The Ohio State University
      • Department of Obstetrics and Gynecology
      Columbus, OH, United States
  • 2003-2007
    • Duke University
      Durham, North Carolina, United States
  • 2002
    • University of Florida Health Science Center-Jacksonville
      Jacksonville, Florida, United States
  • 1999
    • University of Pittsburgh
      • Department of Obstetrics, Gynecology and Reproductive Sciences
      Pittsburgh, Pennsylvania, United States