Objective-To compare morbidity among small-for-gestational-age (SGA; birthweight [BW] < 10 th per... more Objective-To compare morbidity among small-for-gestational-age (SGA; birthweight [BW] < 10 th percentile for gestational age), appropriate-for-gestational-age (AGA; BW 10-90 th percentile; reference group), and large-for-gestational-age (LGA; BW > 90 th percentile) neonates in apparently uncomplicated pregnancies at term (≥ 37 weeks). Material and Methods-This secondary analysis, derived from an observational obstetric cohort of 115,502 deliveries, included women with apparently uncomplicated pregnancies of nonanomalous singletons who had confirmatory ultrasound dating no later than the second trimester, and who delivered between 37 0 and 42 6 weeks. We used two different composite neonatal morbidity outcomes: hypoxic composite neonatal morbidity for SGA and traumatic composite neonatal morbidity for LGA neonates. Log Poisson relative risks (aRR) with 95% confidence intervals (CI), adjusted for potential confounding factors (nulliparity, body mass index, insurance status, and neonatal sex) were calculated. Results-Among the 63,436 women who met our inclusion criteria, SGA occurred in 7.9% (n=4,983) and LGA in 8.3% (n=5,253). Hypoxic composite neonatal morbidity was significantly higher in SGA (1.1%) vs. AGA (0.7%; aRR 1.44, 95% CI 1.07-1.93) but similar between LGA (0.6%) vs. AGA (aRR 0.84; 95% CI 0.58-1.22). Traumatic composite neonatal morbidity was significantly higher in LGA (1.9%) vs. AGA (1.0%; aRR 1.88, 95% CI 1.51-2.34)) but similar in SGA (1.3%) vs. AGA (aRR 1.28; 95% CI 0.98-1.67). Conclusions-Among women with uncomplicated pregnancies, hypoxic composite neonatal morbidity is more common with SGA neonates and traumatic-composite neonatal morbidity is more common with LGA neonates.
Contribution Dr. Hughes participated in conception of the secondary analysis study design and con... more Contribution Dr. Hughes participated in conception of the secondary analysis study design and contributed to critical aspects of the conduct of this research, including monitoring study implementation, progress, data quality, and data analysis. Dr. Hughes provided significant intellectual contribution to the drafting and revision of this article with regard to scientific content and form, and approved the final article as submitted.
Objective-This study aimed to evaluate the association between clinical and examination features ... more Objective-This study aimed to evaluate the association between clinical and examination features at admission and late preterm birth. Study Design-The present study is a secondary analysis of a randomized trial of singleton pregnancies at 34 0/7 to 36 5/7 weeks' gestation. We included women in spontaneous preterm labor with intact membranes and compared them by gestational age at delivery (preterm vs. term). We calculated a statistical cut-point optimizing the sensitivity and specificity of initial cervical dilation and effacement at predicting preterm birth and used multivariable regression to identify factors associated with late preterm delivery. Results-A total of 431 out of 732 (59%) women delivered preterm. Cervical dilation ≥ 4 cm was 60% sensitive and 68% specific for late preterm birth. Cervical effacement ≥ 75% was 59% sensitive and 65% specific for late preterm birth. Earlier gestational age at randomization, nulliparity, and fetal malpresentation were associated with late preterm birth. The final regression model including clinical and examination features significantly improved late preterm birth prediction (81% sensitivity, 48% specificity, area under the curve = 0.72, 95% confidence interval [CI]: 0.68-0.75, and p-value < 0.01). Conclusion-Four in 10 women in late-preterm labor subsequently delivered at term. Combination of examination and clinical features (including parity and gestational age) improved late-preterm birth prediction.
Bjog: An International Journal Of Obstetrics And Gynaecology, Jan 20, 2015
participated in study design and protocol development, and contributed to critical aspects of the... more participated in study design and protocol development, and contributed to critical aspects of the conduct of this research including but not limited to some or all of the following: assessment of patient recruitment; monitoring center performance; oversight of data quality; and evaluation and analysis of data. They provided significant intellectual contribution to the drafting and revision of this manuscript with regard to scientific content and form, and approved the final manuscript as submitted. DETAILS OF ETHICS APPROVAL The primary data collection was approved by the Institutional Review Boards of the Biostatistical Coordinating Center and the clinical sites at which patients were recruited, and all women provided written informed consent. At Columbia University Medical Center, institution of the primary author, this study was designated as protocol IRB-AAAD5071 and first approved on August 7, 2008.
OBJECTIVE: To evaluate whether labor is associated with lower odds of respiratory morbidity among... more OBJECTIVE: To evaluate whether labor is associated with lower odds of respiratory morbidity among neonates born from 36 to 40 weeks of gestation and to assess whether this association varies by gestational age and maternal diabetic status. METHODS: We conducted a secondary analysis of women in the Assessment of Perinatal Excellence obstetric cohort who delivered across 25 U.S. hospitals over a 3-year period. Women with a singleton liveborn non-anomalous neonate who delivered from 36 to 40 weeks of gestation were included in our analysis. Those who received antenatal corticosteroids, underwent amniocentesis for fetal lung maturity, or did not meet dating criteria were excluded. Our primary outcome was composite neonatal respiratory morbidity, which included respiratory distress syndrome, ventilator support, continuous positive airway pressure, or neonatal death. Maternal characteristics and neonatal outcomes between women who labored and those who did not were
American Journal of Obstetrics and Gynecology, Sep 1, 2018
BACKGROUND: Studies of early-term birth after demonstrated fetal lung maturity show that respirat... more BACKGROUND: Studies of early-term birth after demonstrated fetal lung maturity show that respiratory and other outcomes are worse with early-term birth (37 0 e38 6 weeks) even after demonstrated fetal lung maturity when compared with full-term birth (39 0 e40 6 weeks). However, these studies included medically indicated births and are therefore potentially limited by confounding by the indication for delivery. Thus, the increase in adverse outcomes might be due to the indication for early-term birth rather than the early-term birth itself. OBJECTIVE: We examined the prevalence and risks of adverse neonatal outcomes associated with early-term birth after confirmed fetal lung maturity as compared with full-term birth in the absence of indications for early delivery. STUDY DESIGN: This is a secondary analysis of an observational study of births to 115,502 women in 25 hospitals in the United States from 2008 through 2011. Singleton nonanomalous births at 37e40 weeks with no identifiable indication for delivery were included; early-term births after positive fetal lung maturity testing were compared with full-term births. The primary outcome was a composite of death, ventilator for 2 days, continuous positive airway pressure, proven sepsis, pneumonia or meningitis, treated hypoglycemia, hyperbilirubinemia (phototherapy), and 5-minute Apgar <7. Logistic regression and propensity score matching (both 1:1 and 1:2) were used. RESULTS: In all, 48,137 births met inclusion criteria; the prevalence of fetal lung maturity testing in the absence of medical or obstetric indications for early delivery was 0.52% (n ¼ 249). There were 180 (0.37%) early-term births after confirmed pulmonary maturity and 47,957 full-term births. Women in the former group were more likely to be non-Hispanic white, smoke, have received antenatal steroids, have induction, and have a cesarean. Risks of the composite (16.1% vs 5.4%; adjusted odds ratio, 3.2; 95% confidence interval, 2.1e4.8 from logistic regression) were more frequent with elective early-term birth. Propensity scores matching confirmed the increased primary composite in elective early-term births: adjusted odds ratios, 4.3 (95% confidence interval, 1.8e10.5) for 1:1 and 3.5 (95% confidence interval, 1.8e6.5) for 1:2 matching. Among components of the primary outcome, CPAP use and hyperbilirubinemia requiring phototherapy were significantly increased. Transient tachypnea of the newborn, neonatal intensive care unit admission, and prolonged neonatal intensive care unit stay (>2 days) were also increased with early-term birth. CONCLUSION: Even with confirmed pulmonary maturity, early-term birth in the absence of medical or obstetric indications is associated with worse neonatal respiratory and hepatic outcomes compared with fullterm birth, suggesting relative immaturity of these organ systems in earlyterm births.
Journal of Maternal-fetal & Neonatal Medicine, Dec 12, 2012
Objective-Pregnancy complications such as intra-amniotic infection, preeclampsia, and fetal intra... more Objective-Pregnancy complications such as intra-amniotic infection, preeclampsia, and fetal intrauterine growth restriction (IUGR) account for most cases of preterm birth (PTB), but many spontaneous PTB cases do not have a clear etiology. We hypothesize that placental insufficiency may be a potential cause of idiopathic PTB. Methods-Secondary analysis of 82 placental samples from women with PTB obtained from a multicenter trial of repeat versus single antenatal corticosteroids. Samples were centrally reviewed by a single placental pathologist masked to clinical outcomes. The histopathologic criterion for infection was the presence of acute chorioamnionitis defined as neutrophils marginating into the chorionic plate. Placental villous hypermaturation (PVH) was defined as a predominance of terminal villi (similar to term placenta) with extensive syncytial knotting. Idiopathic PTB comprised a group without another known etiology such as preeclampsia, IUGR or infection. Results-Acute chorioamnionitis was observed in 33/82 (40%) cases. Other known causes of PTB were reported in 18/82 (22%). The remaining 31/82 (38%) were idiopathic. The frequency of PVH in idiopathic PTB (26/31=84%) was similar to cases with IUGR or preeclampsia (16/ 18=89%), but significantly more common than PVH in the group with acute chorioamnionitis (10/33=30%) (p<0.001). Conclusions-PVH, which is a histologic marker of relative placental insufficiency, is a common finding in idiopathic PTB.
Ultrasound in Obstetrics & Gynecology, Oct 26, 2018
Objective To evaluate whether the presence of cervical funneling or intra-amniotic debris identif... more Objective To evaluate whether the presence of cervical funneling or intra-amniotic debris identified in the second trimester is associated with a higher rate of preterm birth (PTB) in asymptomatic nulliparous pregnant women with a midtrimester cervical length (CL) less than 30 mm (i.e. below the 10 th percentile). Methods This was a secondary cohort analysis of data from a multicenter trial in nulliparous women between 16 and 22 weeks' gestation with a singleton gestation and CL less than 30 mm on transvaginal ultrasound, randomized to treatment with either 17-alpha-hydroxyprogesterone caproate or placebo. Sonographers were centrally certified in CL measurement, as well as in identification of intra-amniotic debris and cervical funneling. Univariable and multivariable analysis was performed to assess the associations of cervical funneling and intra-amniotic debris with PTB. Results Of the 657 women randomized, 112 (17%) had cervical funneling only, 33 (5%) had intra-amniotic debris only and 45 (7%) had both on second-trimester ultrasound. Women with either of these findings had a shorter median CL than those without (21.0 mm vs 26.4 mm; P < 0.
OBJECTIVE: To evaluate the association between gestational weight gain and maternal and neonatal ... more OBJECTIVE: To evaluate the association between gestational weight gain and maternal and neonatal outcomes in a large, geographically-diverse cohort. METHODS: Trained chart abstractors at 25 hospitals obtained maternal and neonatal data for all deliveries on randomly selected days over 3 years (2008-2011). Gestational weight gain was derived using weight at delivery minus pre-pregnancy or first-trimester weight and categorized as below, within or above the Institute of Medicine (IOM) guidelines in this retrospective cohort study. Maternal (primary or repeat cesarean birth, 3 rd or 4 th degree lacerations, severe postpartum hemorrhage, hypertensive disease of pregnancy) and neonatal (preterm birth, shoulder dystocia, macrosomia, hypoglycemia) outcomes were compared among women in the gestational weight gain categories in unadjusted and adjusted analyses with ORs and 95%CI reported. Covariates included age, race-ethnicity, tobacco use, insurance type, parity, prior cesarean birth, pregestational diabetes, hypertension, and hospital type.
Carolina Digital Repository (University of North Carolina at Chapel Hill), 2013
Objective-Regulatory bodies and insurers evaluate hospital quality using obstetrical outcomes, ho... more Objective-Regulatory bodies and insurers evaluate hospital quality using obstetrical outcomes, however meaningful comparisons should take pre-existing patient characteristics into account. Furthermore, if risk-adjusted outcomes are consistent within a hospital, fewer measures and resources would be needed to assess obstetrical quality. Our objective was to establish risk
American Journal of Obstetrics and Gynecology, 2015
Objective-To compare maternal and neonatal outcomes in nulliparous women with nonmedically indica... more Objective-To compare maternal and neonatal outcomes in nulliparous women with nonmedically indicated inductions at term versus those expectantly managed. Study Design-Data were obtained from maternal and neonatal charts for all deliveries on randomly selected days across 25 US hospitals over a three-year period. A low-risk subset of nulliparas with vertex non-anomalous singleton gestations who delivered 38 0/7 to 41 6/7 weeks were selected. Maternal and neonatal outcomes for non medically indicated induction within each
Carolina Digital Repository (University of North Carolina at Chapel Hill), 2014
OBJECTIVE-To determine whether prior spontaneous (SAB) or induced (IAB) abortions, or the inter-p... more OBJECTIVE-To determine whether prior spontaneous (SAB) or induced (IAB) abortions, or the inter-pregnancy interval are associated with subsequent adverse pregnancy outcomes in nulliparous women. METHODS-We performed a secondary analysis of data collected from nulliparous women enrolled in a completed trial of vitamins C and E or placebo for preeclampsia prevention. Adjusted odds ratios for maternal and fetal outcomes were determined for nulliparous women with prior SABs and IABs as compared to primigravid participants. RESULTS-Compared with primigravidas, women with one prior SAB were at increased risk for perinatal death (OR 1.5; 95% CI 1.1-2.3) in subsequent pregnancies. Two or more SABs were associated with an increased risk for spontaneous preterm birth (OR 2.6, 95% CI 1.7-4.0), preterm PROM (OR 2.9, 95% CI 1.6-5.3) and perinatal death (OR 2.8, 95% CI 1.5-5.3). Women with one previous IAB had higher rates of spontaneous preterm birth (OR 1.4, 95% CI 1.0-1.9) and preterm PROM (OR 2.0, 95% CI 1.4-3.0). An inter-pregnancy interval less than 6 months after SAB was not associated with adverse outcomes.
Carolina Digital Repository (University of North Carolina at Chapel Hill), 2013
To evaluate pregnancy outcomes according to 2009 Institute of Medicine (IOM) gestational weight g... more To evaluate pregnancy outcomes according to 2009 Institute of Medicine (IOM) gestational weight gain guidelines. METHODS-This study is a secondary analysis of a preeclampsia prevention trial among nulliparas carrying singletons. Odds ratios and 95% confidence intervals (adjusted for maternal age, race, smoking, and treatment group) were calculated based on total weight gain below or above the IOM guidelines, stratified by prepregnancy body mass index (BMI). The referent group was weight gain within the guidelines. RESULTS-Of 8,293 pregnancies, 9.5% had weight gain below, 17.5% within, and 73% above IOM guidelines. With excess weight gain, all BMI categories had an increased risk of hypertensive disorders; normal weight and overweight women also had increased risk of cesarean delivery and infant birth weight at or above the 90 th centile but a decreased risk of weight below the10 th centile. There were no consistent associations with insufficient weight gain and adverse outcomes. CONCLUSION-Excess weight gain was prevalent and associated with an increased risk of hypertensive disorders, cesarean delivery and large for gestational age infants..
BACKGROUND-It is uncertain whether treatment of mild gestational diabetes mellitus improves pregn... more BACKGROUND-It is uncertain whether treatment of mild gestational diabetes mellitus improves pregnancy outcomes. METHODS-Women who were in the 24th to 31st week of gestation and who met the criteria for mild gestational diabetes mellitus (i.e., an abnormal result on an oral glucose-tolerance test but a fasting glucose level below 95 mg per deciliter [5.3 mmol per liter]) were randomly assigned to usual prenatal care (control group) or dietary intervention, self-monitoring of blood glucose, and insulin therapy, if necessary (treatment group). The primary outcome was a composite of stillbirth or perinatal death and neonatal complications, including hyperbilirubinemia, hypoglycemia, hyperinsulinemia, and birth trauma. RESULTS-A total of 958 women were randomly assigned to a study group-485 to the treatment group and 473 to the control group. We observed no significant difference between groups in the frequency of the composite outcome (32.4% and 37.0% in the treatment and control groups, respectively; P = 0.14). There were no perinatal deaths. However, there were significant reductions with treatment as compared with usual care in several prespecified secondary outcomes, including
Background-Infants born at 34 to 36 weeks' gestation (late preterm) have greater risks of adverse... more Background-Infants born at 34 to 36 weeks' gestation (late preterm) have greater risks of adverse respiratory and other outcomes, than those born at 37 weeks gestation or later. It is not known whether betamethasone administered to women at risk for late preterm delivery decreases risks of neonatal morbidities.
Cochrane Database of Systematic Reviews, Jan 25, 2006
Each year at least one million children worldwide die of pneumococcal infections. The development... more Each year at least one million children worldwide die of pneumococcal infections. The development of bacterial resistance to antimicrobials adds to the difficulty of treatment of diseases and emphasizes the need for a preventive approach. Newborn vaccination schedules could substantially reduce the impact of pneumococcal disease in immunized children, but does not have an effect on the morbidity and mortality of infants less than three months of age. Pneumococcal vaccination during pregnancy may be a way of preventing pneumococcal disease during the first months of life before the pneumococcal vaccine administered to the infant starts to produce protection. To assess the effect of pneumococcal vaccination during pregnancy for preventing infant infection. We searched the Cochrane Pregnancy and Childbirth Group Trials Register (June 2004), CENTRAL (The Cochrane Library, Issue 2, 2004), MEDLINE (January 1966 to June 2004), EMBASE (January 1985 to June 2004), and reference lists of articles. Randomized controlled trials in pregnant women comparing pneumococcal vaccine with placebo or doing nothing or with another vaccine to prevent infant infections. Two authors independently assessed methodological quality and extracted data using a data collection form. Study authors were contacted for additional information. Three trials (280 participants) were included. There was no evidence that pneumococcal vaccination during pregnancy reduces the risk of neonatal infection (one trial, 149 pregnancies, relative risk (RR) 0.51; 95% confidence interval (CI) 0.18 to 1.41). Although the data suggest an effect in reducing pneumococcal colonisation in infants by 16 months of age (one trial, 56 pregnancies, RR 0.33; 95% CI 0.11 to 0.98), there was no evidence of this effect in infants at two months of age (RR 0.28; 95% CI 0.02 to 5.11) or by seven months of age (RR 0.32; 95% CI 0.08 to 1.29). There is insufficient evidence to support whether pneumococcal vaccination during pregnancy could reduce infant infections.
OBJECTIVE-To compare perinatal outcomes between self-identified Hispanic and non-Hispanic white w... more OBJECTIVE-To compare perinatal outcomes between self-identified Hispanic and non-Hispanic white women with mild gestational diabetes mellitus (GDM) or glucose intolerance. METHODS-In a secondary analysis of a mild GDM treatment trial, we compared perinatal outcomes by race and ethnicity for 767 women with glucose intolerance (abnormal 50g 1-hour screen, normal 100g 3-hour oral glucose tolerance test [OGTT]), 371 women with mild GDM assigned to usual prenatal care, and 397 women with mild GDM assigned to treatment. Outcomes included: composite adverse perinatal outcome (neonatal death, hypoglycemia, hyperbilirubinemia, hyperinsulinemia; stillbirth; birth trauma), gestational age at delivery, birthweight, and hypertensive disorders of pregnancy. Adjusted regression models included: 100g 3-hour OGTT results; parity; gestational age, body mass index, maternal age at enrollment; and current tobacco use. RESULTS-The sample of 1535 women was 68.3% Hispanic and 31.7% non-Hispanic White. Among women with glucose intolerance, Hispanic women had more frequent composite outcome (37% vs. 27%, aOR 1.62 95%CI 1.10, 2.37), with more neonatal elevated C-cord peptide (19% vs. 13%, aOR 1.79 95%CI 1.04, 3.08) and neonatal hypoglycemia (21% vs. 13%, aOR 2.04 95%CI 1.18, 3.53). Among women with untreated mild GDM, outcomes were similar by race/ethnicity. Among Hispanic women with treated mild GDM, composite outcome was similar to non-Hispanic
Objective-To describe factors associated with delayed pushing and evaluate the relationship betwe... more Objective-To describe factors associated with delayed pushing and evaluate the relationship between delayed pushing and perinatal outcomes in nulliparous women with singleton term gestations. Methods-This was a secondary analysis of NICHD Assessment of Perinatal Excellence (APEX) cohort of 115,502 women and their neonates born in 25 U.S. hospitals from 2008-2011. Nulliparous women with singleton, cephalic, nonanomalous term births who achieved 10 cm cervical dilation were included. Women in whom pushing was delayed by ≥60 minutes (delayed group) were compared with those who initiated pushing within 30 minutes (early group). Multivariable regression analyses were used to assess the independent association of delayed pushing with mode of delivery, length of second stage and other maternal and perinatal outcomes (significance defined as p<0.05). Results-Of 21,034 women in the primary analysis sample, pushing was delayed in 18.4% (n=3870). Women who were older, privately insured, or non-Hispanic white, as well as those who
Gummerus 1985 {published data only} Gummerus M, Halonen O. The merits of betamimetic treatment an... more Gummerus 1985 {published data only} Gummerus M, Halonen O. The merits of betamimetic treatment and bed rest in multiple pregnancies [Vuodelevon ja beetasympatomimeettihoidon vaikutus monisikioisessa raskaudessa].
OBJECTIVE-To estimate determinants of and outcomes associated with activity restriction among wom... more OBJECTIVE-To estimate determinants of and outcomes associated with activity restriction among women with a short cervix. METHODS-This was a secondary analysis of a randomized trial of 17-α hydroxyprogesterone caproate for prevention of preterm birth among nulliparous women with singleton gestations and cervices less than 30 mm by midtrimester ultrasonography. Women were asked weekly whether they had been placed on pelvic, work, or nonwork rest. "Any activity restriction" was defined as being placed on any type of rest. Factors associated with any activity restriction were determined and the association between preterm birth and activity restriction was estimated with multivariable logistic regression. RESULTS-Of the 657 women in the trial, 646 (98%) responded to questions regarding activity restriction. Two hundred fifty-two (39.0%) were placed on any activity restriction at a median of 23.9 weeks (interquartile range 22.6-27.9 weeks).Women on activity restriction were older, more
Objective-To compare morbidity among small-for-gestational-age (SGA; birthweight [BW] < 10 th per... more Objective-To compare morbidity among small-for-gestational-age (SGA; birthweight [BW] < 10 th percentile for gestational age), appropriate-for-gestational-age (AGA; BW 10-90 th percentile; reference group), and large-for-gestational-age (LGA; BW > 90 th percentile) neonates in apparently uncomplicated pregnancies at term (≥ 37 weeks). Material and Methods-This secondary analysis, derived from an observational obstetric cohort of 115,502 deliveries, included women with apparently uncomplicated pregnancies of nonanomalous singletons who had confirmatory ultrasound dating no later than the second trimester, and who delivered between 37 0 and 42 6 weeks. We used two different composite neonatal morbidity outcomes: hypoxic composite neonatal morbidity for SGA and traumatic composite neonatal morbidity for LGA neonates. Log Poisson relative risks (aRR) with 95% confidence intervals (CI), adjusted for potential confounding factors (nulliparity, body mass index, insurance status, and neonatal sex) were calculated. Results-Among the 63,436 women who met our inclusion criteria, SGA occurred in 7.9% (n=4,983) and LGA in 8.3% (n=5,253). Hypoxic composite neonatal morbidity was significantly higher in SGA (1.1%) vs. AGA (0.7%; aRR 1.44, 95% CI 1.07-1.93) but similar between LGA (0.6%) vs. AGA (aRR 0.84; 95% CI 0.58-1.22). Traumatic composite neonatal morbidity was significantly higher in LGA (1.9%) vs. AGA (1.0%; aRR 1.88, 95% CI 1.51-2.34)) but similar in SGA (1.3%) vs. AGA (aRR 1.28; 95% CI 0.98-1.67). Conclusions-Among women with uncomplicated pregnancies, hypoxic composite neonatal morbidity is more common with SGA neonates and traumatic-composite neonatal morbidity is more common with LGA neonates.
Contribution Dr. Hughes participated in conception of the secondary analysis study design and con... more Contribution Dr. Hughes participated in conception of the secondary analysis study design and contributed to critical aspects of the conduct of this research, including monitoring study implementation, progress, data quality, and data analysis. Dr. Hughes provided significant intellectual contribution to the drafting and revision of this article with regard to scientific content and form, and approved the final article as submitted.
Objective-This study aimed to evaluate the association between clinical and examination features ... more Objective-This study aimed to evaluate the association between clinical and examination features at admission and late preterm birth. Study Design-The present study is a secondary analysis of a randomized trial of singleton pregnancies at 34 0/7 to 36 5/7 weeks' gestation. We included women in spontaneous preterm labor with intact membranes and compared them by gestational age at delivery (preterm vs. term). We calculated a statistical cut-point optimizing the sensitivity and specificity of initial cervical dilation and effacement at predicting preterm birth and used multivariable regression to identify factors associated with late preterm delivery. Results-A total of 431 out of 732 (59%) women delivered preterm. Cervical dilation ≥ 4 cm was 60% sensitive and 68% specific for late preterm birth. Cervical effacement ≥ 75% was 59% sensitive and 65% specific for late preterm birth. Earlier gestational age at randomization, nulliparity, and fetal malpresentation were associated with late preterm birth. The final regression model including clinical and examination features significantly improved late preterm birth prediction (81% sensitivity, 48% specificity, area under the curve = 0.72, 95% confidence interval [CI]: 0.68-0.75, and p-value < 0.01). Conclusion-Four in 10 women in late-preterm labor subsequently delivered at term. Combination of examination and clinical features (including parity and gestational age) improved late-preterm birth prediction.
Bjog: An International Journal Of Obstetrics And Gynaecology, Jan 20, 2015
participated in study design and protocol development, and contributed to critical aspects of the... more participated in study design and protocol development, and contributed to critical aspects of the conduct of this research including but not limited to some or all of the following: assessment of patient recruitment; monitoring center performance; oversight of data quality; and evaluation and analysis of data. They provided significant intellectual contribution to the drafting and revision of this manuscript with regard to scientific content and form, and approved the final manuscript as submitted. DETAILS OF ETHICS APPROVAL The primary data collection was approved by the Institutional Review Boards of the Biostatistical Coordinating Center and the clinical sites at which patients were recruited, and all women provided written informed consent. At Columbia University Medical Center, institution of the primary author, this study was designated as protocol IRB-AAAD5071 and first approved on August 7, 2008.
OBJECTIVE: To evaluate whether labor is associated with lower odds of respiratory morbidity among... more OBJECTIVE: To evaluate whether labor is associated with lower odds of respiratory morbidity among neonates born from 36 to 40 weeks of gestation and to assess whether this association varies by gestational age and maternal diabetic status. METHODS: We conducted a secondary analysis of women in the Assessment of Perinatal Excellence obstetric cohort who delivered across 25 U.S. hospitals over a 3-year period. Women with a singleton liveborn non-anomalous neonate who delivered from 36 to 40 weeks of gestation were included in our analysis. Those who received antenatal corticosteroids, underwent amniocentesis for fetal lung maturity, or did not meet dating criteria were excluded. Our primary outcome was composite neonatal respiratory morbidity, which included respiratory distress syndrome, ventilator support, continuous positive airway pressure, or neonatal death. Maternal characteristics and neonatal outcomes between women who labored and those who did not were
American Journal of Obstetrics and Gynecology, Sep 1, 2018
BACKGROUND: Studies of early-term birth after demonstrated fetal lung maturity show that respirat... more BACKGROUND: Studies of early-term birth after demonstrated fetal lung maturity show that respiratory and other outcomes are worse with early-term birth (37 0 e38 6 weeks) even after demonstrated fetal lung maturity when compared with full-term birth (39 0 e40 6 weeks). However, these studies included medically indicated births and are therefore potentially limited by confounding by the indication for delivery. Thus, the increase in adverse outcomes might be due to the indication for early-term birth rather than the early-term birth itself. OBJECTIVE: We examined the prevalence and risks of adverse neonatal outcomes associated with early-term birth after confirmed fetal lung maturity as compared with full-term birth in the absence of indications for early delivery. STUDY DESIGN: This is a secondary analysis of an observational study of births to 115,502 women in 25 hospitals in the United States from 2008 through 2011. Singleton nonanomalous births at 37e40 weeks with no identifiable indication for delivery were included; early-term births after positive fetal lung maturity testing were compared with full-term births. The primary outcome was a composite of death, ventilator for 2 days, continuous positive airway pressure, proven sepsis, pneumonia or meningitis, treated hypoglycemia, hyperbilirubinemia (phototherapy), and 5-minute Apgar <7. Logistic regression and propensity score matching (both 1:1 and 1:2) were used. RESULTS: In all, 48,137 births met inclusion criteria; the prevalence of fetal lung maturity testing in the absence of medical or obstetric indications for early delivery was 0.52% (n ¼ 249). There were 180 (0.37%) early-term births after confirmed pulmonary maturity and 47,957 full-term births. Women in the former group were more likely to be non-Hispanic white, smoke, have received antenatal steroids, have induction, and have a cesarean. Risks of the composite (16.1% vs 5.4%; adjusted odds ratio, 3.2; 95% confidence interval, 2.1e4.8 from logistic regression) were more frequent with elective early-term birth. Propensity scores matching confirmed the increased primary composite in elective early-term births: adjusted odds ratios, 4.3 (95% confidence interval, 1.8e10.5) for 1:1 and 3.5 (95% confidence interval, 1.8e6.5) for 1:2 matching. Among components of the primary outcome, CPAP use and hyperbilirubinemia requiring phototherapy were significantly increased. Transient tachypnea of the newborn, neonatal intensive care unit admission, and prolonged neonatal intensive care unit stay (>2 days) were also increased with early-term birth. CONCLUSION: Even with confirmed pulmonary maturity, early-term birth in the absence of medical or obstetric indications is associated with worse neonatal respiratory and hepatic outcomes compared with fullterm birth, suggesting relative immaturity of these organ systems in earlyterm births.
Journal of Maternal-fetal & Neonatal Medicine, Dec 12, 2012
Objective-Pregnancy complications such as intra-amniotic infection, preeclampsia, and fetal intra... more Objective-Pregnancy complications such as intra-amniotic infection, preeclampsia, and fetal intrauterine growth restriction (IUGR) account for most cases of preterm birth (PTB), but many spontaneous PTB cases do not have a clear etiology. We hypothesize that placental insufficiency may be a potential cause of idiopathic PTB. Methods-Secondary analysis of 82 placental samples from women with PTB obtained from a multicenter trial of repeat versus single antenatal corticosteroids. Samples were centrally reviewed by a single placental pathologist masked to clinical outcomes. The histopathologic criterion for infection was the presence of acute chorioamnionitis defined as neutrophils marginating into the chorionic plate. Placental villous hypermaturation (PVH) was defined as a predominance of terminal villi (similar to term placenta) with extensive syncytial knotting. Idiopathic PTB comprised a group without another known etiology such as preeclampsia, IUGR or infection. Results-Acute chorioamnionitis was observed in 33/82 (40%) cases. Other known causes of PTB were reported in 18/82 (22%). The remaining 31/82 (38%) were idiopathic. The frequency of PVH in idiopathic PTB (26/31=84%) was similar to cases with IUGR or preeclampsia (16/ 18=89%), but significantly more common than PVH in the group with acute chorioamnionitis (10/33=30%) (p<0.001). Conclusions-PVH, which is a histologic marker of relative placental insufficiency, is a common finding in idiopathic PTB.
Ultrasound in Obstetrics & Gynecology, Oct 26, 2018
Objective To evaluate whether the presence of cervical funneling or intra-amniotic debris identif... more Objective To evaluate whether the presence of cervical funneling or intra-amniotic debris identified in the second trimester is associated with a higher rate of preterm birth (PTB) in asymptomatic nulliparous pregnant women with a midtrimester cervical length (CL) less than 30 mm (i.e. below the 10 th percentile). Methods This was a secondary cohort analysis of data from a multicenter trial in nulliparous women between 16 and 22 weeks' gestation with a singleton gestation and CL less than 30 mm on transvaginal ultrasound, randomized to treatment with either 17-alpha-hydroxyprogesterone caproate or placebo. Sonographers were centrally certified in CL measurement, as well as in identification of intra-amniotic debris and cervical funneling. Univariable and multivariable analysis was performed to assess the associations of cervical funneling and intra-amniotic debris with PTB. Results Of the 657 women randomized, 112 (17%) had cervical funneling only, 33 (5%) had intra-amniotic debris only and 45 (7%) had both on second-trimester ultrasound. Women with either of these findings had a shorter median CL than those without (21.0 mm vs 26.4 mm; P < 0.
OBJECTIVE: To evaluate the association between gestational weight gain and maternal and neonatal ... more OBJECTIVE: To evaluate the association between gestational weight gain and maternal and neonatal outcomes in a large, geographically-diverse cohort. METHODS: Trained chart abstractors at 25 hospitals obtained maternal and neonatal data for all deliveries on randomly selected days over 3 years (2008-2011). Gestational weight gain was derived using weight at delivery minus pre-pregnancy or first-trimester weight and categorized as below, within or above the Institute of Medicine (IOM) guidelines in this retrospective cohort study. Maternal (primary or repeat cesarean birth, 3 rd or 4 th degree lacerations, severe postpartum hemorrhage, hypertensive disease of pregnancy) and neonatal (preterm birth, shoulder dystocia, macrosomia, hypoglycemia) outcomes were compared among women in the gestational weight gain categories in unadjusted and adjusted analyses with ORs and 95%CI reported. Covariates included age, race-ethnicity, tobacco use, insurance type, parity, prior cesarean birth, pregestational diabetes, hypertension, and hospital type.
Carolina Digital Repository (University of North Carolina at Chapel Hill), 2013
Objective-Regulatory bodies and insurers evaluate hospital quality using obstetrical outcomes, ho... more Objective-Regulatory bodies and insurers evaluate hospital quality using obstetrical outcomes, however meaningful comparisons should take pre-existing patient characteristics into account. Furthermore, if risk-adjusted outcomes are consistent within a hospital, fewer measures and resources would be needed to assess obstetrical quality. Our objective was to establish risk
American Journal of Obstetrics and Gynecology, 2015
Objective-To compare maternal and neonatal outcomes in nulliparous women with nonmedically indica... more Objective-To compare maternal and neonatal outcomes in nulliparous women with nonmedically indicated inductions at term versus those expectantly managed. Study Design-Data were obtained from maternal and neonatal charts for all deliveries on randomly selected days across 25 US hospitals over a three-year period. A low-risk subset of nulliparas with vertex non-anomalous singleton gestations who delivered 38 0/7 to 41 6/7 weeks were selected. Maternal and neonatal outcomes for non medically indicated induction within each
Carolina Digital Repository (University of North Carolina at Chapel Hill), 2014
OBJECTIVE-To determine whether prior spontaneous (SAB) or induced (IAB) abortions, or the inter-p... more OBJECTIVE-To determine whether prior spontaneous (SAB) or induced (IAB) abortions, or the inter-pregnancy interval are associated with subsequent adverse pregnancy outcomes in nulliparous women. METHODS-We performed a secondary analysis of data collected from nulliparous women enrolled in a completed trial of vitamins C and E or placebo for preeclampsia prevention. Adjusted odds ratios for maternal and fetal outcomes were determined for nulliparous women with prior SABs and IABs as compared to primigravid participants. RESULTS-Compared with primigravidas, women with one prior SAB were at increased risk for perinatal death (OR 1.5; 95% CI 1.1-2.3) in subsequent pregnancies. Two or more SABs were associated with an increased risk for spontaneous preterm birth (OR 2.6, 95% CI 1.7-4.0), preterm PROM (OR 2.9, 95% CI 1.6-5.3) and perinatal death (OR 2.8, 95% CI 1.5-5.3). Women with one previous IAB had higher rates of spontaneous preterm birth (OR 1.4, 95% CI 1.0-1.9) and preterm PROM (OR 2.0, 95% CI 1.4-3.0). An inter-pregnancy interval less than 6 months after SAB was not associated with adverse outcomes.
Carolina Digital Repository (University of North Carolina at Chapel Hill), 2013
To evaluate pregnancy outcomes according to 2009 Institute of Medicine (IOM) gestational weight g... more To evaluate pregnancy outcomes according to 2009 Institute of Medicine (IOM) gestational weight gain guidelines. METHODS-This study is a secondary analysis of a preeclampsia prevention trial among nulliparas carrying singletons. Odds ratios and 95% confidence intervals (adjusted for maternal age, race, smoking, and treatment group) were calculated based on total weight gain below or above the IOM guidelines, stratified by prepregnancy body mass index (BMI). The referent group was weight gain within the guidelines. RESULTS-Of 8,293 pregnancies, 9.5% had weight gain below, 17.5% within, and 73% above IOM guidelines. With excess weight gain, all BMI categories had an increased risk of hypertensive disorders; normal weight and overweight women also had increased risk of cesarean delivery and infant birth weight at or above the 90 th centile but a decreased risk of weight below the10 th centile. There were no consistent associations with insufficient weight gain and adverse outcomes. CONCLUSION-Excess weight gain was prevalent and associated with an increased risk of hypertensive disorders, cesarean delivery and large for gestational age infants..
BACKGROUND-It is uncertain whether treatment of mild gestational diabetes mellitus improves pregn... more BACKGROUND-It is uncertain whether treatment of mild gestational diabetes mellitus improves pregnancy outcomes. METHODS-Women who were in the 24th to 31st week of gestation and who met the criteria for mild gestational diabetes mellitus (i.e., an abnormal result on an oral glucose-tolerance test but a fasting glucose level below 95 mg per deciliter [5.3 mmol per liter]) were randomly assigned to usual prenatal care (control group) or dietary intervention, self-monitoring of blood glucose, and insulin therapy, if necessary (treatment group). The primary outcome was a composite of stillbirth or perinatal death and neonatal complications, including hyperbilirubinemia, hypoglycemia, hyperinsulinemia, and birth trauma. RESULTS-A total of 958 women were randomly assigned to a study group-485 to the treatment group and 473 to the control group. We observed no significant difference between groups in the frequency of the composite outcome (32.4% and 37.0% in the treatment and control groups, respectively; P = 0.14). There were no perinatal deaths. However, there were significant reductions with treatment as compared with usual care in several prespecified secondary outcomes, including
Background-Infants born at 34 to 36 weeks' gestation (late preterm) have greater risks of adverse... more Background-Infants born at 34 to 36 weeks' gestation (late preterm) have greater risks of adverse respiratory and other outcomes, than those born at 37 weeks gestation or later. It is not known whether betamethasone administered to women at risk for late preterm delivery decreases risks of neonatal morbidities.
Cochrane Database of Systematic Reviews, Jan 25, 2006
Each year at least one million children worldwide die of pneumococcal infections. The development... more Each year at least one million children worldwide die of pneumococcal infections. The development of bacterial resistance to antimicrobials adds to the difficulty of treatment of diseases and emphasizes the need for a preventive approach. Newborn vaccination schedules could substantially reduce the impact of pneumococcal disease in immunized children, but does not have an effect on the morbidity and mortality of infants less than three months of age. Pneumococcal vaccination during pregnancy may be a way of preventing pneumococcal disease during the first months of life before the pneumococcal vaccine administered to the infant starts to produce protection. To assess the effect of pneumococcal vaccination during pregnancy for preventing infant infection. We searched the Cochrane Pregnancy and Childbirth Group Trials Register (June 2004), CENTRAL (The Cochrane Library, Issue 2, 2004), MEDLINE (January 1966 to June 2004), EMBASE (January 1985 to June 2004), and reference lists of articles. Randomized controlled trials in pregnant women comparing pneumococcal vaccine with placebo or doing nothing or with another vaccine to prevent infant infections. Two authors independently assessed methodological quality and extracted data using a data collection form. Study authors were contacted for additional information. Three trials (280 participants) were included. There was no evidence that pneumococcal vaccination during pregnancy reduces the risk of neonatal infection (one trial, 149 pregnancies, relative risk (RR) 0.51; 95% confidence interval (CI) 0.18 to 1.41). Although the data suggest an effect in reducing pneumococcal colonisation in infants by 16 months of age (one trial, 56 pregnancies, RR 0.33; 95% CI 0.11 to 0.98), there was no evidence of this effect in infants at two months of age (RR 0.28; 95% CI 0.02 to 5.11) or by seven months of age (RR 0.32; 95% CI 0.08 to 1.29). There is insufficient evidence to support whether pneumococcal vaccination during pregnancy could reduce infant infections.
OBJECTIVE-To compare perinatal outcomes between self-identified Hispanic and non-Hispanic white w... more OBJECTIVE-To compare perinatal outcomes between self-identified Hispanic and non-Hispanic white women with mild gestational diabetes mellitus (GDM) or glucose intolerance. METHODS-In a secondary analysis of a mild GDM treatment trial, we compared perinatal outcomes by race and ethnicity for 767 women with glucose intolerance (abnormal 50g 1-hour screen, normal 100g 3-hour oral glucose tolerance test [OGTT]), 371 women with mild GDM assigned to usual prenatal care, and 397 women with mild GDM assigned to treatment. Outcomes included: composite adverse perinatal outcome (neonatal death, hypoglycemia, hyperbilirubinemia, hyperinsulinemia; stillbirth; birth trauma), gestational age at delivery, birthweight, and hypertensive disorders of pregnancy. Adjusted regression models included: 100g 3-hour OGTT results; parity; gestational age, body mass index, maternal age at enrollment; and current tobacco use. RESULTS-The sample of 1535 women was 68.3% Hispanic and 31.7% non-Hispanic White. Among women with glucose intolerance, Hispanic women had more frequent composite outcome (37% vs. 27%, aOR 1.62 95%CI 1.10, 2.37), with more neonatal elevated C-cord peptide (19% vs. 13%, aOR 1.79 95%CI 1.04, 3.08) and neonatal hypoglycemia (21% vs. 13%, aOR 2.04 95%CI 1.18, 3.53). Among women with untreated mild GDM, outcomes were similar by race/ethnicity. Among Hispanic women with treated mild GDM, composite outcome was similar to non-Hispanic
Objective-To describe factors associated with delayed pushing and evaluate the relationship betwe... more Objective-To describe factors associated with delayed pushing and evaluate the relationship between delayed pushing and perinatal outcomes in nulliparous women with singleton term gestations. Methods-This was a secondary analysis of NICHD Assessment of Perinatal Excellence (APEX) cohort of 115,502 women and their neonates born in 25 U.S. hospitals from 2008-2011. Nulliparous women with singleton, cephalic, nonanomalous term births who achieved 10 cm cervical dilation were included. Women in whom pushing was delayed by ≥60 minutes (delayed group) were compared with those who initiated pushing within 30 minutes (early group). Multivariable regression analyses were used to assess the independent association of delayed pushing with mode of delivery, length of second stage and other maternal and perinatal outcomes (significance defined as p<0.05). Results-Of 21,034 women in the primary analysis sample, pushing was delayed in 18.4% (n=3870). Women who were older, privately insured, or non-Hispanic white, as well as those who
Gummerus 1985 {published data only} Gummerus M, Halonen O. The merits of betamimetic treatment an... more Gummerus 1985 {published data only} Gummerus M, Halonen O. The merits of betamimetic treatment and bed rest in multiple pregnancies [Vuodelevon ja beetasympatomimeettihoidon vaikutus monisikioisessa raskaudessa].
OBJECTIVE-To estimate determinants of and outcomes associated with activity restriction among wom... more OBJECTIVE-To estimate determinants of and outcomes associated with activity restriction among women with a short cervix. METHODS-This was a secondary analysis of a randomized trial of 17-α hydroxyprogesterone caproate for prevention of preterm birth among nulliparous women with singleton gestations and cervices less than 30 mm by midtrimester ultrasonography. Women were asked weekly whether they had been placed on pelvic, work, or nonwork rest. "Any activity restriction" was defined as being placed on any type of rest. Factors associated with any activity restriction were determined and the association between preterm birth and activity restriction was estimated with multivariable logistic regression. RESULTS-Of the 657 women in the trial, 646 (98%) responded to questions regarding activity restriction. Two hundred fifty-two (39.0%) were placed on any activity restriction at a median of 23.9 weeks (interquartile range 22.6-27.9 weeks).Women on activity restriction were older, more
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Papers by Jorge Tolosa