Jorge Tolosa

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 340/7 to 365/7 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 l...

 To assess the risk of ischemic placental disease (IPD) including preeclampsia, small for gestational age (SGA), and abruption, in relation to preeclampsia in maternal grandmother, mother, and sister(s).  We performed a secondary analysis of data from a randomized trial of vitamins C and E for preeclampsia prevention. Data on family history of preeclampsia were based on recall by the proband. The associations between family history of preeclampsia and the odds of IPD were evaluated from alternating logistic regressions.  Of the 9,686 women who delivered nonmalformed, singleton live births, 17.1% had IPD. Probands provided data on preeclampsia in 55.5% ( = 5,374) on all three family members, 26.5% ( = 2,562) in mother and sister(s) only, and 11.6% ( = 1,125) in sister(s) only. The pairwise odds ratio (pOR) of IPD was 1.16 (95% confidence interval [CI]: 1.00-1.36) if one or more of the female relatives had preeclampsia. The pORs of preeclampsia were 1.54 (95% CI: 1.12-2.13) and 1.35 (...

Studies of early-term birth after demonstrated fetal lung maturity show that respiratory and other outcomes are worse with early-term birth (37-38 weeks) even after demonstrated fetal lung maturity when compared with full-term birth (39-40 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. 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. 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 37-40 weeks with no identifiable indication for delivery were included; early-t...

To assess whether treatment of pregnant women with subclinical hypothyroidism or hypothyroxinemia alters neonatal TSH results. A planned secondary analysis of data from two multi-center randomized, double-masked, placebo-controlled thyroxine replacement trials in pregnant women with either subclinical hypothyroidism or hypothyroxinemia. Infant heel-stick specimens were obtained before discharge. We compared TSH levels between neonates born to mothers allocated to treatment or placebo within each trial and between neonates in the placebo groups. Multiples of means were generated for day-of-life-specific data. Neonatal TSH values were available for 573/677 (84.6%) newborns from the subclinical hypothyroidism trial and 461/526 (87.6%) newborns from the hypothyroxinemia trial. Neonatal TSH values did not differ in either trial by treatment group or between placebo groups (P > 0.05 for all comparisons). Neonatal TSH values did not differ with thyroid hormone replacement in pregnancies...

To determine the frequency of sepsis and other adverse neonatal outcomes in women with a clinical diagnosis of chorioamnionitis. We performed a secondary analysis of a multi-center placebo-controlled trial of vitamins C/E to prevent preeclampsia in low risk nulliparous women. Clinical chorioamnionitis was defined as either the "clinical diagnosis" of chorioamnionitis or antibiotic administration during labor because of an elevated temperature or uterine tenderness in the absence of another cause. Early-onset neonatal sepsis was categorized as "suspected" or "confirmed" based on a clinical diagnosis with negative or positive blood, urine or cerebral spinal fluid cultures, respectively, within 72 h of birth. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were estimated by logistic regression. Data from 9391 mother-infant pairs were analyzed. The frequency of chorioamnionitis was 10.3%. Overall, 6.6% of the neonates were diagnosed with confi...

Assess if video-based contraceptive education could be an efficient adjunct to contraceptive counseling and attain the same contraceptive knowledge acquisition as conversation-based counseling. This was a multi-center randomized, controlled trial examining contraceptive counseling during labor and maternity hospitalization regarding the options of immediate postpartum contraception. At two urban public hospitals, we randomized participants to a structured conversation with a trained counselor or a 14-min video providing the same information. Both groups received written materials and were invited to ask the counselor questions. Our primary outcome was to compare mean time for video-based education and conversational counseling; secondary outcomes included intended postpartum contraceptive method, pre- and post-intervention contraceptive knowledge, and perceived competence in choosing a method of contraception. We enrolled 240 participants (conversation group=119, video group=121). T...

While there are well-accepted standards for the diagnosis of arrested active-phase labor, the definition of a "failed" induction of labor remains less certain. One approach to diagnosing a failed induction is based on the duration of the latent phase. However, a standard for the minimum duration that the latent phase of a labor induction should continue, absent acute maternal or fetal indications for cesarean delivery, remains lacking. The objective of this study was to determine the frequency of adverse maternal and perinatal outcomes as a function of the duration of the latent phase among nulliparous women undergoing labor induction. This study is based on data from an obstetric cohort of women delivering at 25 U.S. hospitals from 2008-2011. Nulliparous women who had a term singleton gestation in the cephalic presentation were eligible for this analysis if they underwent a labor induction. Consistent with prior studies, the latent phase was determined to begin once cervi...

To evaluate whether the presence of cervical funneling or intra-amniotic debris identified in the second trimester is associated with higher rates of preterm birth (PTB) in asymptomatic nulliparous women with a midtrimester cervical length (CL) less than 30 mm (i.e., less than the 10th percentile). A secondary cohort analysis of a multicenter trial of women between 16 and 22 weeks with a singleton gestation and a CL less than 30 mm by transvaginal ultrasound randomized to either 17-alpha hydroxyprogesterone caproate or placebo. Sonographers were centrally certified in CL measurement, as well as identification of intra-amniotic debris and cervical funneling. Univariable and multivariable analyses were performed. Of the 657 randomized women, 112 (17%) had only a cervical funnel, 33 (5%) had only intra-amniotic debris, and 45 (7%) had both on the second trimester ultrasound. Women with either of these findings had a shorter CL (19.5 vs. 25.6 mm, p<0.001) than those without these fin...

 To compare the risks of adverse maternal and neonatal outcomes associated with spontaneous (SPTB) versus indicated preterm births (IPTB).  A secondary analysis of a multicenter trial of vitamin C and E supplementation in healthy low-risk nulliparous women. Outcomes were compared between women with SPTB (due to spontaneous membrane rupture or labor) and those with IPTB (due to medical or obstetric complications). A primary maternal composite outcome included: death, pulmonary edema, blood transfusion, adult respiratory distress syndrome (RDS), cerebrovascular accident, acute tubular necrosis, disseminated intravascular coagulopathy, or liver rupture. A neonatal composite outcome included: neonatal death, RDS, grades III or IV intraventricular hemorrhage (IVH), sepsis, necrotizing enterocolitis (NEC), or retinopathy of prematurity.  Of 9,867 women, 10.4% ( = 1,038) were PTBs; 32.7% ( = 340) IPTBs and 67.3% ( = 698) SPTBs. Compared with SPTB, the composite maternal outcome was more fr...

 The objective of this study was to estimate whether the decision-to-incision (DTI) time for cesarean delivery (CD) is associated with differences in maternal and neonatal outcomes.  This analysis is of data from women at 25 U.S. medical centers with a term, singleton, cephalic nonanomalous gestation and no prior CD, who underwent an intrapartum CD. Perinatal and maternal outcomes associated with DTI intervals of ≤ 15, 16 to 30, and > 30 minutes were compared.  Among 3,482 eligible women, median DTI times were 46 and 27 minutes for arrest and fetal indications for CD, respectively ( < 0.01). Women with a fetal indication whose DTI interval was > 30 minutes had similar odds to the referent group (DTI of 16-30 minutes) for the adverse neonatal and maternal composites (odds ratio [OR]: 0.83, 95% confidence interval [CI]: 0.40-1.71 and OR: 0.89, 95% CI: 0.63-1.27). For arrest disorders, the odds of the adverse neonatal composite were lower among women with a DTI of > 30 minu...

Background Subclinical thyroid disease during pregnancy may be associated with adverse outcomes, including a lower-than-normal IQ in offspring. It is unknown whether levothyroxine treatment of women who are identified as having subclinical hypothyroidism or hypothyroxinemia during pregnancy improves cognitive function in their children. Methods We screened women with a singleton pregnancy before 20 weeks of gestation for subclinical hypothyroidism, defined as a thyrotropin level of 4.00 mU or more per liter and a normal free thyroxine (T4) level (0.86 to 1.90 ng per deciliter [11 to 24 pmol per liter]), and for hypothyroxinemia, defined as a normal thyrotropin level (0.08 to 3.99 mU per liter) and a low free T4 level (<0.86 ng per deciliter). In separate trials for the two conditions, women were randomly assigned to receive levothyroxine or placebo. Thyroid function was assessed monthly, and the levothyroxine dose was adjusted to attain a normal thyrotropin or free T4 level (depe...

We sought to estimate the effect of indomethacin on duration of pregnancy in women with dilated cervix between 14 (0)/ (7) to 25 (6)/ (7) weeks. Demographics, risk factors, and outcomes were compared in women 14 (0)/ (7) to 25 (6)/ (7) weeks with a dilated cervix > or = 1 cm who received indomethacin versus no indomethacin therapy, stratified for cerclage. Primary outcome was interval from presentation until delivery. Of 222 singleton gestations, 68 (31%) received indomethacin. In unadjusted and adjusted analyses, no significant differences were observed in interval from presentation to delivery and preterm birth < 28, < 32, or < 35 weeks comparing the indomethacin and no indomethacin groups, even after stratification for cerclage. In multivariate logistic regression analysis limited to women receiving cerclage, preterm birth…

To build a nomogram of normal fetal lung volumes and to assess the reproducibility of measurements using 3-dimensional ultrasonography. Inclusion criteria were healthy women, singleton normal pregnancies, reliable dating, and 20 to 30 weeks' gestation. Exclusion criteria were discordance between clinical and ultrasonographic dating, patients lost to follow-up, and birth weight disorders. Patients were scanned at intervals longer than 2 weeks. Three volumes were acquired for each patient; only data from the volume with the best image quality was used for analysis. Volumes were rated and measured by the manual tracing method. We recorded whether the clavicle was visualized. Only good-quality volumes were included in analysis. The best volume was chosen, and each lung was measured. A total of 75 patients were studied over a 9-month period, from which 182 volumes were analyzed. Of the 182 volumes, 15 (8.2%) were excluded for poor quality. The remaining 167 volumes were included in the final analysis. In 83 volumes (50%), the clavicle was not visualized. The best fit for total lung volume was a second-degree polynomial regression curve. Lung volume was 10.28 mL at 20 weeks and 51.49 mL at 30 weeks. Assessment of agreement was studied by selection of 40 volumes. Intraobserver variability was 5.48 mL (10.6%) and 3.07 mL (5.96%). Interobserver variability was 7 mL. Our findings suggest that 3-dimensional ultrasonographically derived measurements are reliable and reproducible up to 30 weeks if a standard measurement technique is used.

The purpose of this study was to evaluate whether demographic and sonographic factors associated with spontaneous preterm birth among nulliparous women with a cervical length of less than 30 mm could be combined into an accurate prediction model for spontaneous preterm birth. We conducted a secondary analysis of a trial of nulliparous women with a singleton gestation and a cervical length of less than 30 mm on transvaginal sonography between 16 and 22 weeks who lacked other risk factors for spontaneous (eg, prior cervical excisional procedure) or medically indicated (eg, chronic hypertension) preterm birth, who were randomized to either 17α-hydroxyprogesterone caproate treatment or a placebo. Risk factors associated with spontaneous preterm birth within the entire cohort were identified by univariable analysis. Factors significantly associated (P < .05) with spontaneous preterm birth were included in a multivariable logistic regression analysis to determine whether an accurate pr...

Objective The objective of this study was to examine whether there is an association between insulin resistance and subsequent development of puerperal infection by measuring insulin resistance in the mid-trimester using the homeostasis model assessment (HOMA:IR). Methods Secondary analysis of low-risk nulliparas enrolled in a multicenter preeclampsia prevention trial. HOMA:IR was measured on fasting plasma glucose and insulin concentrations among low-risk nulliparas between 22 and 26 weeks' gestation. Median HOMA:IR was compared between women who did and did not develop puerperal infection using Wilcoxon rank sum test. Logistic regression was used to control for potential confounders. Results Of 1,180 women with fasting glucose and insulin available, 121 (10.3%) had a puerperal infection. Median HOMA:IR was higher among those with subsequent puerperal infection (4.3 [interquartile, IQR: 2.2-20.5] vs. 2.6 [IQR: 1.5-6.7], p < 0.0001). After controlling for potentially confounding variables HOMA:IR was only marginally associated with an increased risk of development of puerperal infection, adjusted odds ratio: 1.01 (95% confidence interval: 1.00-1.02; p = 0.04) per unit increase. Elevated HOMA:IR performed poorly as a predictor of puerperal infection, with a positive predictive value of 15% and a negative predictive value of 92%. Conclusion Though associated with an increased risk of puerperal infection, insulin resistance, measured by HOMA:IR, is not a clinically useful predictor of puerperal infection.

Small-for-gestational-age (SGA) infants are at risk for premature death from cardiovascular disease (myocardial infarction and stroke), hypertension, and diabetes in adult life. Severe intrauterine growth restriction is often associated with subclinical cardiovascular abnormalities detectable during fetal echocardiography. The objective of this study was to determine whether SGA newborns have evidence of myocardial injury at birth. Cardiac troponin I, a specific marker of myocardial injury widely used for the diagnosis of myocardial infarction in adults, was determined in umbilical cord blood. Umbilical cord venous blood was obtained at the time of birth from 72 SGA newborns (birth weight below the 10th centile for gestational age) and 309 newborns whose birth weights were appropriate for gestational age (AGA). Cardiac troponin I was determined with a commercially available immunoassay (sensitivity 0.2 ng/ml) employed in clinical laboratories (Immulite 2000, Diagnostic Products Corp., Los Angeles, CA). Cardiac troponin I was not detectable in any of the blood samples from AGA infants. In contrast, 4.2% (3/72) of SGA infants had detectable cardiac troponin I in umbilical cord blood (Fisher's exact test, p = 0.007). A subgroup of SGA newborns undergoes myocardial injury before birth. This insult may predispose to the development of adult premature cardiovascular disease and death.

To determine if rank position on the match list of a maternal-fetal medicine (MFM) fellowship program predicted applicant academic success. The Thomas Jefferson University MFM fellowship program rank order lists and the results of the match were reviewed for 1991-2002. Evaluation of candidates includes an application, 3 letters of recommendation, curriculum vitae and interview upon invitation. Career success of graduated fellows was defined as MFM board certification, number of peer-reviewed publications and of Society for MFM (SMFM) abstract publications. Applicants ranked higher tended to have more peer-reviewed publications per applicant (9.2 vs. 4.7 vs. 4.4, p = 0.5) and more abstracts presented at SMFM (7.6 vs. 8.0 vs. 3.8 p = 0.5) as compared to lower-ranked applicants. Ranked applicants had a higher probability of being MFM board certified (74 vs. 22%, p = 0.005), having more peer-reviewed publications (6.8 vs. 1.4, p = 0.005), and more abstracts (7.1 vs. 2.1, p < 0.0001) as compared to nonranked applicants. MFM fellowship applicants who were ranked higher were more likely to publish as compared to lower-ranked applicants. Ranked applicants were more likely to publish and be MFM board certified as compared to nonranked applicants.

Background Infants who are born at 34 to 36 weeks of gestation (late preterm) are at greater risk for adverse respiratory and other outcomes than those born at 37 weeks of gestation or later. It is not known whether betamethasone administered to women at risk for late preterm delivery decreases the risks of neonatal morbidities. Methods We conducted a multicenter, randomized trial involving women with a singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation who were at high risk for delivery during the late preterm period (up to 36 weeks 6 days). The participants were assigned to receive two injections of betamethasone or matching placebo 24 hours apart. The primary outcome was a neonatal composite of treatment in the first 72 hours (the use of continuous positive airway pressure or high-flow nasal cannula for at least 2 hours, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least 4 hours, extracorporeal membrane oxygenation, or mechani...

Although preterm birth less than 37 weeks gestation is the leading cause of neonatal morbidity and mortality in the United States, the majority of data regarding preterm neonatal outcomes come from older studies, and many reports have been limited to only very preterm neonates. Delineation of neonatal outcomes by delivery gestational age is needed to further clarify the continuum of mortality and morbidity frequencies among preterm neonates. We sought to describe the contemporary frequencies of neonatal death, neonatal morbidities, and neonatal length of stay across the spectrum of preterm gestational ages. Secondary analysis of an obstetric cohort of 115,502 women and their neonates who were born in 25 hospitals nationwide, 2008-2011. All live born non-anomalous singleton preterm (23.0-36.9 weeks of gestation) neonates were included in this analysis. The frequency of neonatal death, major neonatal morbidity (intraventricular hemorrhage grade III/IV, seizures, hypoxic-ischemic encephalopathy, necrotizing enterocolitis stage II/III, bronchopulmonary dysplasia, persistent pulmonary hypertension), and minor neonatal morbidity (hypotension requiring treatment, intraventricular hemorrhage grade 1/2, necrotizing enterocolitis stage 1, respiratory distress syndrome, hyperbilirubinemia requiring treatment) were calculated by delivery gestational age; each neonate was classified once by the worst outcome they met criteria for. 8,334 deliveries met inclusion criteria. There were 119 neonatal deaths (1.4%). 657 (7.9%) neonates had major morbidity, 3,136 (37.6%) had minor morbidity, and 4,422 (53.1%) survived without any of the studied morbidities. Deaths declined rapidly with each advancing week of gestation. This decline in death was accompanied by an increase in major neonatal morbidity, which peaked at 54.8% at 25 weeks of gestation. As frequencies of death, and major neonatal morbidity fell, minor neonatal morbidity increased, peaking at 81.7% at 31 weeks of gestation. The frequency of all morbidities fell beyond 32 weeks. Neonatal length of hospital stay decreased significantly with each additional completed week of pregnancy; among babies delivered from 26 to 32 weeks of gestation, each additional week in utero reduced the subsequent length of neonatal hospitalization by a minimum of 8 days. The median post-menstrual age at discharge nadired at 35.7 weeks post-menstrual age for babies born at 32-33 weeks of gestation. Our data show that there is a continuum of outcomes, with each additional week for gestation conferring survival benefit while reducing the length of initial hospitalization. These contemporary data can be useful for patient counseling regarding preterm outcomes.

INTRODUCTION: In Colombia, pesticide exposure has became a public health problem, as the use of these substances continues to increase.OBJECTIVE: The current study accumulated information concerning pesticides used by flower companies in Bogotá and Rionegro (Antioquia) that were associated with Asociación Colombiana de Exportadores de Flores (Asocolflores) in Colombia.MATERIALS AND METHODS: Eighty-four companies were stratified by geographic location and size. Company and worker information was collected, and for each company, the process of pesticide application and maintenance of the cultivated flowers was carefully observed. Univariate and bivariate, and correlation analyses were applied for data analysis.RESULTS: Sex of workers was 39.4% male and 60.6% female. Pesticides were grouped into 4 toxicity classes: 14.3% were class I, 14.4% class II, 52.0% class III, and 19.2% class IV. Dithiocarbamates was the group of pesticides more commonly used (11.7%). The equipment most frequently used for pesticide application was the "bomba móvil" (92.8%), and the "lanza" (92.9%). Cholinesterase activity measured by the Michel-Aldrige method was the biological marker for exposure to pesticides used in 85.9% of the companies. Recommendations for improvements in their use and for measures to further reduce exposure of workers are made.

Cesarean delivery in the second stage of labor is common, whereas the frequency of operative vaginal delivery has been declining. However, data comparing outcomes for attempted operative vaginal delivery in the second stage versus cesarean in the second stage are scant. Previous studies that examine operative vaginal delivery have compared it to a baseline risk of complications from a spontaneous vaginal delivery and cesarean delivery. However, when a woman has a need for intervention in the second stage, spontaneous vaginal delivery is not an option she or the provider can choose. Thus, the appropriate clinical comparison is cesarean versus operative vaginal delivery. Our objective was to compare outcomes by the first attempted operative delivery (vacuum, forceps versus cesarean delivery) in patients needing second stage assistance at a fetal station of +2 or below. Secondary analysis of an observational obstetric cohort in 25 academically-affiliated U.S. hospitals over a three-yea...