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1.  Cost-Effectiveness of Trial of Labor After Previous Cesarean in a Minimally Biased Cohort 
Objective
To estimate the cost-effectiveness of a trial of labor after one previous cesarean delivery (TOLAC).
Study Design
A model comparing TOLAC with elective repeat cesarean delivery (ERCD) was developed for a hypothetical cohort with no contraindication to a TOLAC. Probabilistic estimates were obtained from women matched on their baseline characteristics using propensity scores. Cost data, quality adjusted-life-years (QALYs) and data on cerebral palsy were incorporated from the literature.
Results
The TOLAC strategy dominated the ERCD strategy at baseline, with $138.6 million saved and 1703 QALYs gained per 100,000 women. The model was sensitive to five variables; the probability of uterine rupture, the probability of successful TOLAC, the QALY of failed TOLAC, the cost of ERCD and the cost of successful TOLAC without complications. When the probability of TOLAC success was at the base value, 68.5%, TOLAC was preferred if the probability of uterine rupture was 4.2% or less. When the probability of uterine rupture was at the base value, 0.8%, the TOLAC strategy was preferred as long as the probability of success was 42.6% or more.
Conclusion
A TOLAC is less expensive and more effective than an ERCD in a group of women with balanced baseline characteristics.
doi:10.1055/s-0032-1333206
PMCID: PMC4049080  PMID: 23292916
cost-effectiveness; elective repeat cesarean; trial of labor; propensity scores
2.  Environmental risk factors and perinatal outcomes in preterm newborns, according to family recurrence of prematurity 
American journal of perinatology  2012;30(6):451-461.
Objetive
We analyzed the role of environmental risk factors, socio-demographic characteristics, clinical characteristics, and reproductive history in preterm births and their associated perinatal outcomes in families classified according to their histories of preterm recurrence among siblings.
Study Design
A retrospective study was conducted at “Nuestra Señora de la Merced” Maternity Hospital in the city of Tucumán, Argentina. A total of 348 preterm, non-malformed, singleton children born to multipara women were reviewed. The family history score described by Khoury was applied, and families were classified as having no, medium or high genetic aggregation.
Results
Families with no familial aggregation showed a higher rate of short length of cohabitation, maternal urinary tract infections during the current pregnancy and maternal history of miscarriage during the previous pregnancy. Families with a high level of aggregation had a significantly higher incidence of pregnancy complications, such as diabetes, hypertension and immunological disorders.
Conclusion
Reproductive histories clearly differed between the groups, suggesting both a different response to environmental challenges based on genetic susceptibility, and the activation of different pathophysiological pathways to determine the duration of pregnancy in each woman.
doi:10.1055/s-0032-1326990
PMCID: PMC3974336  PMID: 23132119
preterm birth; familial aggregation; pregnancy
3.  Nifedipine pharmacokinetics are influenced by CYP3A5 genotype when used as a preterm labor tocolytic 
American journal of perinatology  2012;30(4):275-281.
Objective
To characterize the pharmacokinetics and pharmacogenetics of nifedipine in pregnancy.
Study Design
Pregnant women receiving oral nifedipine underwent steady-state pharmacokinetic testing over one dosing interval. DNA was obtained and genotyped for cytochrome P450 (CYP) 3A5, and CYP3A4*1B. Nifedipine and oxidized nifedipine concentrations were measured in plasma and pharmacokinetic parameters were compared between those women who expressed a CYP3A5*1 allele and those who expressed only variant CYP3A5 alleles (*3,*6, or *7).
Results
Fourteen women had complete data to analyze. Four women (29%) expressed variant CYP3A5; three of these women were also CYP3A4*1B allele carriers. The mean half-life of nifedipine was 1.68±1.56 hours. AUC0–6 for the women receiving nifedipine every 6 hours was 207±138μg·h/L. Oral clearance was different between high expressers and low expressers (232.0±37.8 μg/mL vs. 85.6±45.0 μg/mL, respectively; p=0.007).
Conclusion
CYP3A5 genotype influences the oral clearance of nifedipine in pregnant women.
doi:10.1055/s-0032-1323590
PMCID: PMC4039203  PMID: 22875663
nifedipine; pharmacokinetics; pharmacogenetics; pregnancy; tocolysis
4.  The Obstetric and Neonatal Implications of a Low Value on the 50-g Glucose Screening Test 
American journal of perinatology  2012;30(9):715-722.
Objective
To assess the relationship between a low 50-g 1-hour glucose loading test (GLT) and maternal and neonatal outcomes in women without diabetes.
Study Design
This was a secondary analysis of a multicenter observational cohort from a randomized trial of treatment for mild gestational diabetes. Maternal and neonatal outcomes were compared between women with GLT values < 90 mg/dL and those with results 90 to 119 mg/dL.
Results
Of 436 enrolled women, 297 (68.1%) had a GLT result of 90 to 119 mg/dL and 139 (31.9%) had a result of < 90 mg/dL. There was a lower incidence of neonatal hypoglycemia in those with a GLT < 90 mg/dL (5.7% versus 16.5%, p = 0.006). Other outcomes were not associated with test results.
Conclusion
A GLT result < 90 mg/dL compared with 90 to 119 mg/dL is associated with a lower risk of neonatal hypoglycemia, but no other significant findings.
doi:10.1055/s-0032-1331027
PMCID: PMC4022774  PMID: 23271384
low glucose screening test; neonatal hypoglycemia
5.  Medical and Non-Medical Factors Influencing Utilization of Delayed Pushing in the Second Stage 
American journal of perinatology  2012;30(7):595-600.
Objective
To evaluate factors impacting selection to delayed pushing in the second stage of labor.
Study design
This case-control study was a secondary analysis of a large retrospective cohort study. Cases included women who delayed pushing for 60 minutes or more in the second stage of labor. Controls began pushing prior to 60 minutes from the time of diagnosis of complete dilation. Demographic, labor, and nonmedical factors were compared among cases and controls. Logistic regression modelling was used to identify factors independently associated with delayed pushing.
Results
We identified 471 women who delayed pushing and 4,819 controls. Nulliparity, maternal body mass index > 25, high fetal station at complete dilation, regional anesthesia use, and start of second stage during staffing shift change were independent factors associated with increased use of delayed pushing. On the other hand, black race and second stage management during night shift were associated with lower odds of employing delayed pushing. Delayed pushing was more commonly employed in nulliparous women, but 38.9% of multiparous women also delayed pushing.
Conclusion
We identified multiple factors associated with use of delayed pushing. This study helps to define current patterns of second stage labor management.
doi:10.1055/s-0032-1329689
PMCID: PMC4015065  PMID: 23208765
Delayed pushing; labor management; second stage
6.  Population versus Customized Fetal Growth Norms and Adverse Outcomes in an Intrapartum Cohort 
American journal of perinatology  2012;30(4):335-342.
Objective
To compare population versus customized fetal growth norms in identifying neonates at risk for adverse outcomes (APO) associated with small for gestational age (SGA).
Study Design
Secondary analysis of an intrapartum fetal pulse oximetry trial in nulliparous women at term. Birthweight percentiles were calculated using ethnicity- & gender-specific population norms and customized norms (Gardosi).
Results
508 (9.9%) and 584 (11.3%) neonates were SGA by population (SGApop) and customized (SGAcust) norms. SGApop infants were significantly associated with a composite adverse neonatal outcome, neonatal intensive care admission, low fetal oxygen saturation and reduced risk of cesarean delivery; while both SGApop and SGAcust were associated with a 5-minute Apgar score < 4. The ability of customized and population birthweight percentiles in predicting APO was poor (12 out of 14 APOs had AUC <0.6).
Conclusion
In this intrapartum cohort, neither customized nor normalized-population norms adequately identify neonates at risk of APO related to SGA.
doi:10.1055/s-0032-1324708
PMCID: PMC3622136  PMID: 22893556
customized norm; fetal growth; small for gestational age; adverse outcomes
7.  Association of Adverse Perinatal Outcomes with Screening Measures of Obstructive Sleep Apnea 
American journal of perinatology  2011;28(8):651-658.
Objective
This prospective observational study explored the association of hypertensive disorders of pregnancy and small-for-gestational age (SGA) with obstructive sleep apnea (OSA) as determined by screening measures for OSA and sleep studies.
Study Design
Two symptom-based screening questionnaires, the Berlin Questionnaire (BQ) and the Epworth Sleepiness Scale (ESS), were administered to enroll 1509 gravidae. Screen positive subjects were referred for polysomnography (PSG). The primary outcome was the occurrence of either gestational hypertension or preeclampsia. [a1]Generalized linear models (GLM) were used to estimate the relative risks of associations.
Results
1157 subjects were available for outcomes analysis. Screening positive on the BQ was positively associated with hypertensive disorders in GLM models (aRR=1.90, 95%CI 1.52–2.37).
Conclusion
In this large prospective trial, GLM modeling suggest that the BQ but not the ESS demonstrated significant association with measured adverse pregnancy outcomes, and specific items predicted these outcomes better than others. However, causative association of BQ with OSA cannot be assumed.
doi:10.1055/s-0031-1276740
PMCID: PMC3966067  PMID: 21480159
Obesity; Obstructive Sleep Apnea; Preeclampsia; Sleep-Disordered Breathing
8.  The Impact of Tobacco Use on Preterm Premature Rupture of the Membranes 
American journal of perinatology  2012;30(3):185-190.
Objective
To determine if tobacco use increases the incidence of preterm premature rupture of the membranes (pPROM) or alters perinatal outcomes after pPROM.
Study Design
This is a secondary analysis of the databases of three completed Eunice Kennedy Shriver National Institute of Child Health and Human Development–supported Maternal Fetal Medicine Units Network studies. Self-reported tobacco exposure data was obtained. Its relationship with the incidence of pPROM and associated neonatal outcome measures were assessed.
Results
There was no difference in the incidence of pPROM when comparing non-smokers to those using tobacco. Although a trend was seen between the incidence of pPROM and the amount smoked, this did not reach statistical significance. Among the patients with pPROM, the use of tobacco was not associated with an increase in perinatal morbidity.
Conclusion
Our data do not support a significant relationship between tobacco use and pPROM.
doi:10.1055/s-0032-1322517
PMCID: PMC3962832  PMID: 22930157
tobacco; premature rupture of the membranes
9.  Role of Innate Immunity in Neonatal Infection 
American journal of perinatology  2013;30(2):105-112.
Newborns are at increased risk of infection due to genetic, epigenetic, and environmental factors. Herein we examine the roles of the neonatal innate immune system in host defense against bacterial and viral infections. Full-term newborns express a distinct innate immune system biased towards TH2/TH17-polarizing and anti-inflammatory cytokine production with relative impairment in TH1-polarizing cytokine production that leaves them particularly vulnerable to infection with intracellular pathogens. In addition to these distinct features, preterm newborns also have fragile skin, impaired TH17-polarizing cytokine production and deficient expression of complement and of antimicrobial proteins and peptides (APPs) that likely contribute to susceptibility to pyogenic bacteria. Ongoing research is identifying APPs, including bacterial/permeability-increasing protein and lactoferrin, as well as pattern recognition receptor (PRR) agonists that may serve to enhance protective newborn and infant immune responses as stand alone immune response modifiers or vaccine adjuvants.
doi:10.1055/s-0032-1333412
PMCID: PMC3959733  PMID: 23297181
adjuvants; neonatal sepsis; pathogen recognition receptors; innate immunity
10.  The investment case for preventing NICU-associated infections 
American journal of perinatology  2012;30(3):179-184.
Nosocomial (hospital-associated or NICU-associated) infections occur in as many as 10–36% of very low birth weight infants cared for in newborn intensive care units (NICU).
Objective
To determine the potentially avoidable, incremental costs of care associated with NICU-associated bloodstream infections.
Study Design
This is a retrospective study that included all NICU admissions of infants 401–1500 grams birth weight in the greater Cincinnati region from January 1, 2005 through December 31, 2007. Non-physician costs of care were compared between infants who developed at least one bacterial bloodstream infection prior to NICU discharge or death and infants who did not. Costs were adjusted for clinical and demographic characteristics that are present in the first three days of life and are known associates of infection.
Results
Among 900 study infants with no congenital anomaly and no major surgery, 82 (9.1%) developed at least one bacterial bloodstream infection. On average, the cost of NICU care was $16,800 greater per infant who experienced NICU-associated bloodstream infection.
Conclusions
Potentially avoidable costs of care associated with bloodstream infection can be used to justify investments in the reliable implementation of evidence-based interventions designed to prevent these infections.
doi:10.1055/s-0032-1322516
PMCID: PMC3789586  PMID: 22836823
quality improvement; investment case; nosocomial infection
11.  The Effect of Maternal Body Mass Index on Perinatal Outcomes in Women with Diabetes 
American journal of perinatology  2013;31(3):249-256.
Objective
To determine the effect of increasing maternal obesity, including superobesity (body mass index [BMI] ≥ 50 kg/m2), on perinatal outcomes in women with diabetes.
Study Design
Retrospective cohort study of birth records for all live-born nonanom-alous singleton infants ≥ 37 weeks’ gestation born to Missouri residents with diabetes from 2000 to 2006. Women with either pregestational or gestational diabetes were included.
Results
There were 14,595 births to women with diabetes meeting study criteria, including 7,082 women with a BMI > 30 kg/m2 (48.5%). Compared with normal-weight women with diabetes, increasing BMI category, especially superobesity, was associated with a significantly increased risk for preeclampsia (adjusted relative risk [aRR] 3.6, 95% confidence interval [CI] 2.5, 5.2) and macrosomia (aRR 3.0, 95% CI 1.8, 5.40). The majority of nulliparous obese women with diabetes delivered via cesarean including 50.5% of obese, 61.4% of morbidly obese, and 69.8% of superobese women. The incidence of primary elective cesarean among nulliparous women with diabetes increased significantly with increasing maternal BMI with over 33% of morbidly obese and 39% of superobese women with diabetes delivering electively by cesarean.
Conclusion
Increasing maternal obesity in women with diabetes is significantly associated with higher risks of perinatal complications, especially cesarean delivery.
doi:10.1055/s-0033-1347363
PMCID: PMC3852172  PMID: 23696430
cesarean; diabetes; obesity; superobesity
12.  Blood Pressure Changes during Pregnancy: Impact of Race, Body Mass Index, and Weight Gain 
American journal of perinatology  2012;30(5):415-424.
Objective
To investigate the effect of race, body mass index (BMI), and weight gain on blood pressure in pregnancy and postpartum.
Study Design
Secondary analysis of pregnant women aged 14 to 25 who received prenatal care at a university-affiliated public clinic in New Haven, Connecticut and delivered singleton term infants (n = 418). Longitudinal multivariate analysis was used to evaluate blood pressure trajectories from pregnancy through 12 weeks postpartum.
Results
Obese and overweight women had significantly higher blood pressure readings as compared with women with normal BMI (all p < 0.05). African American women who had high pregnancy weight gain had the greatest increase in mean arterial and diastolic blood pressures in pregnancy and postpartum.
Conclusion
Blood pressure trajectories in pregnancy and postpartum are significantly affected by race, BMI, and weight gain. Given the young age of this cohort, targeted efforts must be made for postpartum weight reduction to reduce cardiovascular risk.
doi:10.1055/s-0032-1326987
PMCID: PMC3938313  PMID: 23059493
pregnancy; weight gain; obesity; racial differences
13.  Vitamin A Supplementation in Extremely Low- Birth-Weight Infants: Subgroup Analysis in Small-for-Gestational-Age Infants 
American journal of perinatology  2013;30(9):771-780.
Objective
Preterm infants with intrauterine growth restriction are at increased risk of respiratory distress syndrome and bronchopulmonary dysplasia (BPD). A randomized clinical trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network demonstrated that vitamin A supplementation in extremely low-birth-weight (ELBW) preterm infants requiring early respiratory support decreased the risk of developing BPD.
Study Design
A subgroup analysis of small-for-gestational-age (SGA) infants from the original NICHD trial was performed to test the hypothesis that in infants requiring early respiratory support, vitamin A supplementation decreases the relative risk of BPD or death in premature SGA infants to a greater extent than in gestational age–equivalent vitamin A–treated appropriate-for-gestational-age (AGA) infants.
Results
Although vitamin A supplementation significantly increased serum retinol concentrations in AGA ELBW infants (median [5th percentile, 95th percentile]: 16.3 [−7.0, 68.8] versus 2.4 [−13.9, 55.1]; p < 0.001), no increases were noted in SGA ELBW infants.
Conclusions
Given the limited power of this analysis due to a low number of SGA infants, these data did not provide evidence to support the hypothesis that vitamin A supplementation in preterm SGA infants requiring early respiratory support decreases the relative risk of BPD or death as compared with preterm AGA infants.
doi:10.1055/s-0032-1333410
PMCID: PMC3923571  PMID: 23329565
vitamin A; IUGR–intrauterine growth restriction; BPD–bronchopulmonary dysplasia; SGA–small for gestational age; AGA–appropriate for gestational age
14.  Hepatitis C Virus in Pregnancy 
American journal of perinatology  2013;30(2):10.1055/s-0033-1334459.
Despite recent advances in the pathogenesis, treatment, and public health response to hepatitis C virus (HCV), HCV as it specifically relates to pregnancy has been a neglected condition and a markedly improved public health response to these populations is needed. HCV-monoinfected pregnant women have a 2–8% risk of viral transmission to their infant, but the mechanism and timing of mother to child transmission (MTCT) are not fully understood, nor is the natural history of the illness in pregnant women and their offspring. Recognition of HCV is relevant to infected pregnant women because of their risk of the long-term complications of infection, potential effects of infection on pregnancy, and risk of transmission to their infants. Certain risk factors for mother to child transmission (MTCT) of HCV appear similar to those for human immunodeficiency virus (HIV), however, unlike HIV, effective methods of prevention of HCV vertical transmission have not been developed. It is possible that a better understanding of HCV pathogenesis in pregnancy and MTCT of HCV infection will lead to useful prevention strategies, particularly as we enter an era where interferon-free drug cocktails may emerge as viable treatment options for HCV
doi:10.1055/s-0033-1334459
PMCID: PMC3862252  PMID: 23389935
Hepatitis C Virus (HCV); Pregnancy; Mother to Child Transmission; Screening
15.  Comparative Analysis of 2-D Versus 3-D Ultrasound Estimation of the Fetal Adrenal Gland Volume and Prediction of Preterm Birth 
American journal of perinatology  2012;29(9):10.1055/s-0032-1314887.
Objective
We aim to test the hypothesis that 2D fetal AGV measurements offer similar volume estimates as volume calculations based on 3D technique
Methods
Fetal AGV was estimated by 3D ultrasound (VOCAL) in 93 women with signs/symptoms of preterm labor and 73 controls. Fetal AGV was calculated using an ellipsoid formula derived from 2D measurements of the same blocks (0.523× length × width × depth). Comparisons were performed by intra-class correlation coefficient (ICC), coefficient of repeatability, and Bland-Altman method. The cAGV (AGV/fetal weight) was calculated for both methods and compared for prediction of PTB within 7 days.
Results
Among 168 volumes, there was a significant correlation between 3D and 2D methods (ICC=0.979[95%CI: 0.971-0.984]). The coefficient of repeatability for the 3D was superior to the 2D method (Intra-observer 3D: 30.8, 2D:57.6; inter-observer 3D: 12.2, 2D: 15.6). Based on 2D calculations, a cAGV≥433mm3/kg, was best for prediction of PTB (sensitivity: 75%(95%CI=59-87); specificity: 89%(95%CI=82-94). Sensitivity and specificity for the 3D cAGV (cut-off ≥420mm3/kg) was 85%(95%CI=70-94) and 95%(95%CI=90-98), respectively. In receiver-operating-curve curve analysis, 3D cAGV was superior to 2D cAGV for prediction of PTB (z=1.99, p=0.047).
Conclusion
2D volume estimation of fetal adrenal gland using ellipsoid formula cannot replace 3D AGV calculations for prediction of PTB.
doi:10.1055/s-0032-1314887
PMCID: PMC3838705  PMID: 22644825
3D ultrasound; volume measurement; fetal adrenal gland; preterm birth
16.  Barriers to Follow-up for Women with a History of Gestational Diabetes 
American journal of perinatology  2010;27(9):10.1055/s-0030-1253102.
Objective
Women with gestational diabetes (GDM) are at increased risk for type 2 diabetes (T2DM), but many do not receive recommended follow-up. We sought to identify barriers to follow-up screening.
Study design
We surveyed primary care (PCPs) and obstetric and gynecology care providers (OBCPs) in a large health system. We also assessed documentation of GDM history in the health care system’s electronic medical record.
Results
478 clinicians were surveyed, among whom 207 responded. Most participants (81.1%) gave an accurate estimate of risk of progression to T2DM. PCPs were less likely than OBCPs to ask patients about history of GDM (OR 0.43, 95% CI 0.20–0.90), but they were far more likely to indicate that they order glucose screening for women with a known history (OR 4.31, 95% CI 2.01–9.26). Providers identified poor communication between OBCPs and PCPs as a major barrier to screening. Fewer than half (45.8%) of 450 women with GDM by GTT criteria had that history documented on their electronic problem list.
Conclusions
Clinicians are aware that women with GDM are at high risk of developing type 2 diabetes, but they do not routinely assess and screen patients, and communication between OBCPs and PCPs can be improved.
doi:10.1055/s-0030-1253102
PMCID: PMC3811130  PMID: 20387186
gestational diabetes; evidence-based practice; electronic medical record; type 2 diabetes
17.  Cytokines and Post-hemorrhagic Ventricular Dilation in Premature Infants 
American journal of perinatology  2012;29(9):731-740.
Objective
To determine in extremely low birth weight (ELBW) infants if elevated blood inteferon-γ (IFN-γ), interleukin-1β (IL-1β), IL-18, tumor necrosis factor-α (TNF-α), and transforming growth factor-β (TGFβ) are associated with need for shunt following severe intraventricular hemorrhage (IVH), or with ventricular dilation following milder grades /no IVH.
Study design
Whole blood cytokines were measured on postnatal days 1, 3, 7, 14, and 21. Maximum IVH grade in the first 28d, and shunt surgery or ventricular dilation on subsequent ultrasound (28d -36 w PMA) were determined.
Results
Of 902 infants in the NICHD NRN Cytokine study who survived to 36w/discharge, 3.1% had shunts. Of the 12% of infants with severe (Gr III–IV) IVH, 26% had a shunt associated with elevated TNF-α. None of the infants without IVH (69%) or with Gr I (12%) or II (7%) IVH received shunts, but 8.4% developed ventricular dilation, associated with lower IFN-γ and higher IL-18.
Conclusion
Statistically significant but clinically non-discriminatory alterations in blood cytokines were noted in infants with severe IVH who received shunts and in those without severe IVH who developed ventricular dilation. Blood cytokines are likely associated with brain injury but may not be clinically useful as biomarkers for white matter damage.
doi:10.1055/s-0032-1316443
PMCID: PMC3619127  PMID: 22773292
Infant; premature; Cytokines; Hydrocephalus; Intraventricular hemorrhage; Intracranial hemorrhage
18.  Assessment of Obstetric and Neonatal Health Services in Developing Country Health Facilities 
American journal of perinatology  2013;30(9):787-794.
Objective
To describe the staffing and availability of medical equipment and medications and the performance of procedures at health facilities providing maternal and neonatal care at African, Asian, and Latin American sites participating in a multicenter trial to improve emergency obstetric/neonatal care in communities with high maternal and perinatal mortality.
Study Design
In 2009, prior to intervention, we surveyed 136 hospitals and 228 clinics in 7 sites in Africa, Asia, and Latin America regarding staffing, availability of equipment/ medications, and procedures including cesarean section.
Results
The coverage of physicians and nurses/midwives was poor in Africa and Latin America. In Africa, only 20% of hospitals had full-time physicians. Only 70% of hospitals in Africa and Asia had performed cesarean sections in the last 6 months. Oxygen was unavailable in 40% of African hospitals and 17% of Asian hospitals. Blood was unavailable in 80% of African and Asian hospitals.
Conclusions
Assuming that adequate facility services are necessary to improve pregnancy outcomes, it is not surprising that maternal and perinatal mortality rates in the areas surveyed are high. The data presented emphasize that to reduce mortality in these areas, resources that result in improved staffing and sufficient equipment, supplies, and medication, along with training, are required.
doi:10.1055/s-0032-1333409
PMCID: PMC3664648  PMID: 23329566
emergency obstetric and neonatal care; developing countries; perinatal mortality
19.  The Relationship of the Factor V Leiden Mutation and Pregnancy Outcomes for Mother and Fetus 
American journal of perinatology  2011;29(3):225-230.
Objective
We sought to estimate the frequency of pregnancy-related thromboembolic events among carriers of the factor V Leiden (FVL) mutation without a personal history of thromboembolism, and to evaluate the impact of maternal and fetal FVL mutation carriage or other thrombophilias on the risk of adverse outcomes.
Methods
Women with a singleton pregnancy and no history of thromboembolism were recruited at 13 clinical centers before 14 weeks of gestation from April 2000 to August 2001. Each was tested for the FVL mutation, as was the resultant conceptus after delivery or after miscarriage, when available. The incidence of thromboembolism (primary outcome), and of other adverse outcomes, was compared between FVL mutation carriers and noncarriers. We also compared adverse outcomes in a secondary nested carrier-control analysis of FVL mutation and other coagulation abnormalities. In this secondary analysis, we defined carriers as women having one or more of the following traits: carrier for FVL mutation, protein C deficiency, protein S deficiency, antithrombin III deficiency, activated protein C resistance, or lupus anticoagulant-positive, heterozygous for prothrombin G20210A or homozygous for the 5,10 methylenetetrahydrofolate reductase mutations. Carriers of the FVL mutation alone (with or without activated protein C resistance) were compared with those having one or more other coagulation abnormalities and with controls with no coagulation abnormality.
Results
One hundred thirty-four FVL mutation carriers were identified among 4,885 gravidas (2.7%), with both FVL mutation status and pregnancy outcomes available. No thromboembolic events occurred among the FVL mutation carriers (0%, 95% confidence interval 0–2.7%). Three pulmonary emboli and one deep venous thrombosis occurred (0.08%, 95% confidence interval 0.02–0.21%), all occurring in FVL mutation noncarriers. In the nested carrier-control analysis (n = 339), no differences in adverse pregnancy outcomes were observed between FVL mutation carriers, carriers of other coagulation disorders, and controls. Maternal FVL mutation carriage was not associated with increased pregnancy loss, preeclampsia, placental abruption, or small for gestational age births. However, fetal FVL mutation carriage was associated with more frequent preeclampsia among African-American (15.0%) and Hispanic (12.5%) women than white women (2.6%, P = .04), adjusted odds ratio 2.4 (95% confidence interval 1.0–5.2, P = .05).
Conclusion
Among women with no history of thromboembolism, maternal heterozygous carriage of the FVL mutation is associated with a low risk of venous thromboembolism in pregnancy. Neither universal screening for the FVL mutation, nor treatment of low-risk carriers during pregnancy is indicated.
doi:10.1055/s-0031-1285097
PMCID: PMC3770153  PMID: 21818732
20.  Prenatal Methamphetamine Exposure and Short-Term Maternal and Infant Medical Outcomes 
American journal of perinatology  2012;29(5):391-400.
Objective
Examine maternal and infant medical outcomes of prenatal exposure to methamphetamine (MA).
Study Design
Four hundred and twelve mother-infant pairs (204 MA-exposed and 208 unexposed matched comparisons) were enrolled in the Infant Development, Environment and Lifestyle (IDEAL) study. Exposure was determined by maternal self-report during this pregnancy and/or positive meconium toxicology. Maternal interviews assessed prenatal drug use, pregnancy course, and sociodemographic information. Medical chart reviews provided medical history, obstetric complications, infant outcomes, and discharge placement.
Results
MA-using mothers were more likely to be poor, to have a psychiatric disorder/emotional illness and less prenatal care, and to be less likely to breast-feed their infant than comparison mothers. After adjusting for covariates, MA-exposed infants were more likely to exhibit poor suck, to have smaller head circumferences and length, to require neonatal intensive care unit (NICU) admission, and to be referred to child protective services (CPS). Several outcomes previously reported from studies that lacked adequate control groups or adjustment for covariates were not significantly different in this study.
Conclusion
Prenatal MA exposure is associated with maternal psychiatric disorder/emotional illness, poor suck, NICU admission, and CPS involvement, and MA-exposed infants were less likely to be breast-fed; however, the absence of many serious complications, such as fetal distress, chronic hypertension, preeclampsia, placenta previa, abruptio placentae, and cardiac defects, suggests confounding variables influenced prior studies.
doi:10.1055/s-0032-1304818
PMCID: PMC3717348  PMID: 22399214
amphetamine; methamphetamine; drug; antenatal; neonate
21.  The Effects of Prenatal Methamphetamine Exposure on Childhood Growth Patterns from Birth to 3 Years of Age 
American journal of perinatology  2011;29(3):203-210.
We examined the effects of prenatal methamphetamine (MA) exposure on growth parameters from birth to age 3 years. The 412 subjects included (n = 204 exposed) were enrolled at birth in the Infant Development, Environment and Lifestyle study, a longitudinal study assessing the effects of prenatal MA exposure on childhood outcomes. Individual models were used to examine the effects of prenatal MA exposure on weight, head circumference, height, and weight-for-length growth trajectories. After adjusting for covariates, height trajectory was lower in the exposed versus the comparison children (p = 0.021) over the first 3 years of life. Both groups increased height on average by 2.27 cm per month by age 3 years. In term subjects, MA exposure was also associated with a lower height trajectory (p = 0.034), with both the exposed and comparison groups gaining 2.25 cm per month by age 3 years. There was no difference in weight, head circumference, or weight-for-length growth trajectories between the comparison and the exposed groups. Children exposed prenatally to MA have a modest decrease in height growth trajectory during the first 3 years of life with no observed difference in weight, head circumference, or weight-for-length trajectories.
doi:10.1055/s-0031-1285094
PMCID: PMC3717349  PMID: 21818727
height; antenatal; drug; amphetamine
22.  Fetal Placental Thrombosis and Neonatal Implications 
American journal of perinatology  2009;27(3):251-256.
We present the neonatal complications of two premature newborn infants whose placentas demonstrated placental thrombosis in the fetal circulation. Both mothers presented with a 3-day history of decreased fetal movements before delivery. The first infant presented with thrombocytopenia and disseminated intravascular coagulation. The second infant had extended bilateral extended hemorrhagic venous infarctions. Severe fetal placental vascular lesions seem to be a predisposing factor for some adverse neonatal outcomes. We present these two cases with a brief review of the literature.
doi:10.1055/s-0029-1239486
PMCID: PMC3694425  PMID: 19806531
Newborn; placenta; fetal thrombotic vasculopathy; brain infarct
23.  Early Fetal Echocardiography: Ready for Prime Time? 
American journal of perinatology  2011;29(4):313-318.
The objective of this study was to examine the performance of early fetal echocardiography as a screening tool for major cardiac defects in a high-risk population. Fetal echocardiograms performed at 12 to 16 weeks were reviewed. Cases that did not undergo a follow-up echocardiogram at 18 to 22 weeks were excluded. Results of the early and follow-up echocardiograms were compared. Over a 4-year period, 119 early fetal echocardiograms were recorded. Of those, 81 (68%) had follow-up fetal echocardiograms. Results of the early echocardiogram were normal in 77 of 81 (95.1%) cases. Of these, the follow-up was normal in 75 of these 77 cases; in the remaining 2, the follow-up raised suspicion for a ventricular septal defect (VSD) in one and persistent left superior vena cava in the other. On the other hand, the early echocardiogram was abnormal in 4 (4.9%) cases: (1) atrioventricular canal defect, with the follow-up demonstrating a VSD; (2) hypoplastic right ventricle and transposition of the great arteries, confirmed on follow-up; (3) VSD and coarctation of the aorta, confirmed on follow-up. In the fourth case, the early echocardiogram suspected a VSD and right-left disproportion, yet the follow-up was normal. In conclusion, early fetal echocardiography appears to be a reasonable screening tool for major cardiac defects.
doi:10.1055/s-0031-1295640
PMCID: PMC3681520  PMID: 22143968
fetal echocardiography; fetal heart; congenital heart disease; prenatal diagnosis
24.  Is obesity an independent barrier to obtaining prenatal care? 
American journal of perinatology  2012;30(5):401-406.
Objective
Obesity is a demonstrated barrier to obtaining healthcare. Its impact on obtaining prenatal care (PNC) is unknown. Our objective was to determine if obesity is an independent barrier to accessing early and adequate PNC.
Study Design
We performed a retrospective cohort study of women who initiated PNC and delivered at our institution in 2005. BMI was categorized by World Health Organization guidelines: underweight (<18.5kg/m2), normal weight (18.5–24.9kg/m2), overweight (25.0–29.9kg/m2), and obese (≥30 kg/m2). Maternal history and delivery information were obtained through chart abstraction. Differences in gestational age at first visit (GA-1) and adequate PNC were evaluated by BMI category. Data were compared using χ2 and non-parametric analyses.
Results
410 women were evaluated. Overall, the median GA-1 was 11.1 weeks and 69% had adequate PNC. There was no difference in GA-1 or adequate PNC by BMI category (p=0.17 and p=0.66, respectively). When BMI groups were dichotomized into obese and non-obese women, there was no difference in GA-1 or adequate PNC, p=0.41.
Conclusion
In our population, obesity is not an independent barrier to receiving early and adequate PNC. Future work is warranted in evaluating the association between obesity and PNC and the perceived barriers to obtaining care.
doi:10.1055/s-0032-1326984
PMCID: PMC3670139  PMID: 23023556
Obesity; access; adequate prenatal care
25.  The Association between Body Mass Index and Gestational Diabetes Mellitus Varies by Race/Ethnicity 
American journal of perinatology  2011;28(7):515-520.
We examined body mass index (BMI) as a screening tool for gestational diabetes (GDM) and its sensitivity among different racial/ethnic groups. In a retrospective cohort study of 24,324 pregnant women at University of California, San Francisco, BMI was explored as a screening tool for GDM and was stratified by race/ethnicity. Sensitivity and specificity were examined using chi-square test and receiver-operator characteristic curves. BMI of ≥25.0 kg/m2 as a screening threshold identified GDM in >76% of African-Americans, 58% of Latinas, and 46% of Caucasians, but only 25% of Asians (p<0.001). Controlling for confounders and comparing to a BMI of ≤25, African-Americans had the greatest increased risk of GDM (adjusted odds ratio [AOR] 5.1, 95% confidence interval [CI]: 3.0 to 8.5), followed by Caucasians (AOR 3.6, 95% CI: 2.7 to 4.8), Latinas (AOR 2.7, 95% CI: 1.9 to 3.8), and Asians (AOR 2.3, 95% CI: 1.8 to 3.0). BMI’s screening characteristics to predict GDM varied by race/ethnicity. BMI can be used to counsel regarding the risk of developing GDM, but alone it is not a good screening tool.
doi:10.1055/s-0031-1272968
PMCID: PMC3666587  PMID: 21404165
Body mass index; gestational diabetes mellitus; glucose loading test; race/ethnicity; receiver-operator characteristic curve

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