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Biomedical subjects

M Miodovnik

Publications and source records attributed to M Miodovnik.

At least 19 recordsLinked to original sources

Consequences of smoking and caffeine consumption during pregnancy in women with type 1 diabetes.

OBJECTIVE: To test the hypothesis that, in women with type 1 diabetes, prenatal smoking and caffeine consumption during pregnancy are associated with an increased risk of adverse maternal and perinatal outcomes. METHODS: A secondary analysis of data on pregnant women with type 1 diabetes from an interdisciplinary program of Diabetes in Pregnancy. Women were interviewed monthly, by a trained non-medical member of the research team, using a standardized questionnaire, to ascertain daily smoking habits and caffeine consumption. RESULTS: Smoking and caffeine information were available on 191 pregnancies, 168 progressing beyond 20 weeks of gestation. Early pregnancy smoking (OR 3.3, 95% CI 1.2, 8.7) and caffeine consumption (OR 4.5, 95% CI 1.2, 16.8) were associated with increased risk of spontaneous abortion when controlling for age, years since diagnosis of diabetes, previous spontaneous abortion, nephropathy and retinopathy. Smoking throughout pregnancy was significantly associated with decreased birth weight and prolonged neonatal hospital stay. Smoking throughout pregnancy (OR 0.2, 95% 0.1, 1.0) and caffeine consumption after 20 weeks (OR 0.3, 95% CI 0.1, 1.0) were associated with reduced risk of pre-eclampsia. CONCLUSIONS: Caffeine consumption during early pregnancy, regardless of glycemic control, increases the risk of spontaneous abortion. Smoking throughout pregnancy and caffeine consumption are associated with reduced risk of pre-eclampsia.

Abortion, Spontaneous↗

Intrapartum fetal head position I: comparison between transvaginal digital examination and transabdominal ultrasound assessment during the active stage of labor.

OBJECTIVE: To test the null hypothesis that no correlation exists between transvaginal digital and the gold standard technique of transabdominal suprapubic ultrasound assessments of fetal head position during labor. A secondary objective was to compare the performance of attending physicians vs. senior residents in depicting fetal head position by transvaginal digital examination in comparison with ultrasound, respectively. METHODS: Consecutive patients in active labor at term with normal singleton cephalic-presenting fetuses were included. All participants had ruptured membranes, cervical dilation > or = 4 cm and fetal head at ischial spine station -2 or lower. Transvaginal sterile digital examinations were performed by either senior residents or attending physicians and followed immediately by transverse suprapubic transabdominal ultrasound assessments. Examiners were blinded to each other's findings. Power-analyses dictated number of subjects required. Statistical analyses included Chi-square, Cohen's Kappa test and logistic regression analysis. P < 0.05 was considered statistically significant. RESULTS: One hundred and two patients were studied (n = 102). In only 24% of patients (n = 24), transvaginal digital examinations were consistent with ultrasound assessments (P = 0.002, 95% confidence interval, 16-33). Logistic regression revealed that cervical effacement (P = 0.03) and ischial spine station (P = 0.01) significantly affected the accuracy of transvaginal digital examination. Parity, gestational age, combined spinal epidural anesthesia, cervical dilation, birth weight and examiner experience did not significantly affect accuracy of the examination. The accuracy of the transvaginal digital exams was increased to 47% (n = 48) (95% confidence interval, 37-57) when fetal head position at transvaginal digital examination was recorded as correct if reported within +/- 45 degrees of the ultrasound assessment. The rate of agreement between the two assessment methods for attending physicians vs. residents was 58% vs. 33%, respectively (P = 0.02) with the +/- 45 degrees analysis. CONCLUSIONS: Using ultrasound assessment as the gold standard, our data demonstrate an overall high rate of error (76%) in transvaginal digital determination of fetal head position during active labor, consistent with the null hypothesis. Attending physicians exhibited an almost two-fold higher success rate in depicting correct fetal head position by physical examination vs. residents in the +/- 45 degrees analysis. Intrapartum ultrasound increases the accuracy of fetal head position assessment during active labor and may serve as an educational tool for physicians in training.

Adolescent↗

Intrapartum fetal head position II: comparison between transvaginal digital examination and transabdominal ultrasound assessment during the second stage of labor.

OBJECTIVE: To test the null hypothesis that no correlation exists between transvaginal digital examination compared with the gold standard technique of transabdominal suprapubic ultrasound assessment of fetal head position during the second stage of labor. A secondary objective was to compare the performance of attending physicians vs. senior residents in depicting fetal head position by transvaginal digital examination in comparison with ultrasound assessment. METHODS: Consecutive patients in the second-stage of labor at term with normal singleton cephalic-presenting fetuses and ruptured membranes were included. Transvaginal digital examinations were performed by either attending physicians or senior residents and were followed immediately by transverse suprapubic transabdominal sonographic assessments performed by a single sonographer. Examiners were blinded to each other's findings. Power analysis dictated sample size. Exact binomial confidence intervals around observed rates were compared with chi 2 and Cohen's kappa-tests. Logistic regression was applied. P < 0.05 was considered significant throughout. RESULTS: One hundred and twelve patients were studied. The absolute error of transvaginal digital examinations was recorded in 65% of patients (95% confidence interval, 56-74%). Parity, pelvic station, combined spinal epidural anesthesia, length of first or second stages of labor, use of oxytocin augmentation, gestational age, mode of delivery, birth weight, and examiner experience did not significantly affect examination accuracy. Stratification, when the transvaginal digital examination was recorded as correct if occurring within +/- 45 degrees of the ultrasound assessment, reduced the error of the transvaginal digital examinations to 39% (95% confidence interval, 30-49%). Independent variables again did not affect examination accuracy in this assessment modality. Rates of agreement between the two methods for attending physicians compared with residents were not significantly different. The overall degrees of agreement were 40% (95% confidence interval, 26-55%) and 68% (95% confidence interval, 53-80%) (kappa = 0.25 and 0.30) for the absolute agreement and +/- 45 degrees assessment modalities, respectively, for attending physicians, and 31% (95% confidence interval, 20-44%) and 55% (95% confidence interval, 42-68%) (kappa = 0.14 and 0.12) for senior residents. CONCLUSION: Using ultrasound assessment as the gold standard, our data demonstrate a high rate of error (65%) in transvaginal digital determination of fetal head position during the second stage of labor. The performance of senior residents in transvaginal digital examinations did not differ significantly from that of attending physicians. Intrapartum ultrasound increases the accuracy of fetal head position assessment during the second stage of labor.

Adolescent↗

A planned randomized clinical trial of treatment for mild gestational diabetes mellitus.

OBJECTIVE: A planned study is described which will determine whether a benefit exists for the treatment of mild carbohydrate intolerance during pregnancy. METHODS: A randomized clinical trial of women with mild gestational diabetes will compare perinatal outcomes in those receiving diet therapy and insulin as required versus those randomized to no specific treatment. RESULTS: The primary outcome of this study will be a composite of neonatal morbidity in the treatment and control groups. CONCLUSIONS: A randomized treatment trial of mild gestational diabetes mellitus will clarify whether identification and treatment of mild gestational diabetes mellitus reduces perinatal morbidity. This information will aid in selecting appropriate thresholds for the treatment of gestational diabetes mellitus.

Cohort Studies↗

Is the use of insulin lispro safe in pregnancy?

OBJECTIVE: To provide a review of the use and safety of insulin lispro during pregnancy. METHODS: This is a review of the available literature on the use of insulin lispro in pregnancy. A MEDLINE search was performed which included published manuscripts and abstracts in the English language to June 2001. RESULTS: The extensive search revealed that data on insulin lispro use during pregnancy are limited. Most of the reports on the use of insulin lispro during pregnancy demonstrated improvement of glycemic control, an increase in patient satisfaction, decreased hypoglycemic episodes, improved maternal and neonatal outcomes, and no deterioration in retinal status. However, there were two reports where it was suggested that there was an association with the use of insulin lispro in pregnancy and increased risk for the development of congenital anomalies and/or development or progression of diabetic retinopathy. CONCLUSIONS: Preliminary data suggest that insulin lispro does not have adverse maternal or fetal effects during pregnancy in women with diabetes. The use of insulin lispro during pregnancy results in improved glycemic control, fewer hypoglycemic episodes, improved patient satisfaction, improved maternal and neonatal outcomes and no deterioration in retinal status. There is no evidence that the use of insulin lispro during pregnancy results in an increased rate of congenital malformations. A prospective randomized clinical trial is imperative for further evaluation of any possible association with the use of insulin lispro during pregnancy and an increased rate of congenital malformations or change in retinal status.

Congenital Abnormalities↗

Pregnancy outcome and progression of diabetic nephropathy. What's next?

OBJECTIVES: The first objective was to assess the association of renal function with maternal and fetal pregnancy outcome in women with diabetic nephropathy. The second objective was to examine the feasibility of a multicenter surveillance program to determine the rates of maternal and fetal pregnancy complications in women with diabetic nephropathy, and to study the effect of pregnancy on the natural history of diabetic renal disease. METHODS: In order to address the first objective, we analyzed data from women with type 1 diabetes and nephropathy enrolled in the Diabetes in Pregnancy Program at our institution. Women were assigned to one of three groups according to enrolment serum creatinine concentration: < or = 1.0 mg/dl, > 1.0 to 1.5 mg/dl and > 1.5 mg/dl. A pilot surveillance program at six centers included women experiencing pregnancy complicated by diabetic nephropathy. In both studies, medical and obstetric history, and maternal and neonatal outcomes, were recorded. Statistical analysis included chi2, logistic regression and analysis of variance. RESULTS: There were 72 pregnancies in 58 women with diabetic nephropathy who enrolled in the pregnancy program. High serum creatinine concentration at enrolment was associated with delivery before 32 weeks' gestation, very low birth weight and increased incidence of neonatal hypoglycemia, independent of quantity of total urinary protein excretion and glycemic control in any trimester. To date, pilot surveillance data have been obtained from six centers on 16 women. Serum creatinine concentrations ranged from 0.4 to 1.1 mg/dl and creatinine clearance from 32 to 317 m/min. Gestational age at delivery ranged from 22 to 39 weeks. CONCLUSIONS: High serum creatinine concentration at enrolment is a risk factor for adverse maternal and neonatal outcome, independent of quantity of total urinary protein excretion and glycemic control during any trimester. A multicenter surveillance program is needed, in order to study less frequent maternal and neonatal outcomes as well as the long-term effects of pregnancy on the natural course of diabetic renal disease.

Biomarkers↗

Spontaneous preterm delivery in the type 1 diabetic pregnancy: the role of glycemic control.

OBJECTIVE: To determine the role of glycemic control in spontaneous preterm delivery in type 1 diabetic women. METHODS: A secondary analysis of data from women enrolled in the Diabetes in Pregnancy Program prior to 20 weeks was performed. Multiple logistic regression was used to analyze the association between glycohemoglobin A1 in women with spontaneous preterm delivery (n = 53) and women who delivered at term (n = 200). Maternal demographics and obstetric outcomes were also compared between the groups. RESULTS: Glycohemoglobin A1 levels were higher in the spontaneous preterm delivery group than the term group throughout pregnancy, reaching statistical significance after the first trimester. The last glycohemoglobin A1 prior to delivery was 8.1% in the spontaneous preterm delivery group and 7.4% in the term group (p = 0.002). Using multiple logistic regression, each 1% increase in glycohemoglobin A1 increased the risk of spontaneous preterm delivery by 37%. CONCLUSION: Poor glycemic control is associated with an increased risk of spontaneous preterm delivery, suggesting that strict glycemic control may reduce the rate of preterm delivery in these women.

Adult↗

Mid-trimester endovaginal sonography in women at high risk for spontaneous preterm birth.

CONTEXT: Although shortened cervical length has been consistently associated with spontaneous preterm birth, it is not known when in gestation this risk factor becomes apparent. OBJECTIVE: To determine whether sonographic cervical findings between 16 weeks' and 18 weeks 6 days' gestation predict spontaneous preterm birth and whether serial evaluations up to 23 weeks 6 days' gestation improve prediction in high-risk women. DESIGN, SETTING, AND PARTICIPANTS: Blinded observational study performed between March 1997 and November 1999 at 9 university-affiliated medical centers in the United States in 183 women with singleton gestations who previously had experienced a spontaneous birth before 32 weeks' gestation. OBSERVATION: Certified sonologists performed 590 endovaginal sonographic examinations at 2-week intervals. Cervical length was measured from the external os to the functional internal os along a closed endocervical canal. Funneling and dynamic cervical shortening were also recorded. MAIN OUTCOME MEASURE: Spontaneous preterm birth before 35 weeks' gestation, analyzed by selected cutoff values of cervical length. RESULTS: Forty-eight women (26%) experienced spontaneous preterm birth before 35 weeks' gestation. A cervical length of less than 25 mm at the initial sonographic examination was associated with a relative risk (RR) for spontaneous preterm birth of 3.3 (95% confidence interval [CI], 2.1-5.0; sensitivity = 19%; specificity = 98%; positive predictive value = 75%). After controlling for cervical length, neither funneling (P =.24) nor dynamic shortening (P =.054) were significant independent predictors of spontaneous preterm birth. However, using the shortest ever observed cervical length on serial evaluations, after any dynamic shortening, the RR of a cervical length of less than 25 mm for spontaneous preterm birth increased to 4.5 (95% CI, 2.7-7.6; sensitivity = 69%; specificity = 80%; positive predictive value = 55%). Compared with a single cervical measurement at 16 weeks' to 18 weeks 6 days' gestation, serial measurements at up to 23 weeks 6 days significantly improved the prediction of spontaneous preterm birth in a receiver operating characteristic curve analysis (P =.03). CONCLUSIONS: Cervical length assessed by endovaginal sonography between 16 weeks' and 18 weeks 6 days' gestation, augmented by serial evaluations, predicts spontaneous preterm birth before 35 weeks' gestation in high-risk women.

Adult↗

Failure of metronidazole to prevent preterm delivery among pregnant women with asymptomatic Trichomonas vaginalis infection.

BACKGROUND: Infection with Trichomonas vaginalis during pregnancy has been associated with preterm delivery. It is uncertain whether treatment of asymptomatic trichomoniasis in pregnant women reduces the occurrence of preterm delivery. METHODS: We screened pregnant women for trichomoniasis by culture of vaginal secretions. We randomly assigned 617 women with asymptomatic trichomoniasis who were 16 to 23 weeks pregnant to receive two 2-g doses of metronidazole (320 women) or placebo (297 women) 48 hours apart. We treated women again with the same two-dose regimen at 24 to 29 weeks of gestation. The primary outcome was delivery before 37 weeks of gestation. RESULTS: Between randomization and follow-up, trichomoniasis resolved in 249 of 269 women for whom follow-up cultures were available in the metronidazole group (92.6 percent) and 92 of 260 women with follow-up cultures in the placebo group (35.4 percent). Data on the time and characteristics of delivery were available for 315 women in the metronidazole group and 289 women in the placebo group. Delivery occurred before 37 weeks of gestation in 60 women in the metronidazole group (19.0 percent) and 31 women in the placebo group (10.7 percent) (relative risk, 1.8; 95 percent confidence interval, 1.2 to 2.7; P=0.004). The difference was attributable primarily to an increase in preterm delivery resulting from spontaneous preterm labor (10.2 percent vs. 3.5 percent; relative risk, 3.0; 95 percent confidence interval, 1.5 to 5.9). CONCLUSIONS: Treatment of pregnant women with asymptomatic trichomoniasis does not prevent preterm delivery. Routine screening and treatment of asymptomatic pregnant women for this condition cannot be recommended.

Adult↗

Dietary fiber intakes and insulin requirements in pregnant women with type 1 diabetes.

OBJECTIVE: To determine whether higher dietary fiber intake (water soluble and insoluble) is associated with lower insulin requirements and better glycemic control in pregnant women with type 1 diabetes consuming a self-selected diet. DESIGN: A longitudinal, observational study. SUBJECTS: Pregnant women (n=141) with type 1 diabetes participating in an interdisciplinary program examining the effects of glycemic control on pregnancy outcome (Diabetes and Pregnancy Program, University of Cincinnati Medical Center). MEASUREMENTS: We determined total, water soluble and insoluble fiber intakes from 3-day food records kept each trimester during pregnancy. Outcome measures were insulin dose, pre-meal blood glucose, and glycated hemoglobin concentrations. STATISTICAL ANALYSES: Correlation coefficients, multiple regression, mixed-model analysis of variance. RESULTS: Mean intakes (g/day) of total, water soluble fiber, and insoluble fiber were 14.0 (range, 1.8-33.1), 4.8 (range, 0.6-10.5) and 9.0 (range, 1.1-24.0), respectively. In the second and third trimesters of pregnancy, insulin requirements were inversely associated with total, water soluble, and insoluble fiber intakes; the correlation coefficients ranged from -0.22 to -0.17 (P=.02 to .08). Insulin requirements associated with a higher fiber intake (20.5 g/day) were 16% to 18% lower than for a lower fiber intake (8.1 g/day). These relations remained after adjustment for body weight, disease severity and duration, insulin type, and study year in the second (P=.03 to .10) but not in the third trimester. Pre-meal blood glucose and glycated hemoglobin concentrations were not associated with fiber intake. CONCLUSIONS: Among pregnant women with type 1 diabetes, higher fiber intake is associated with lower daily insulin requirements. Dietary fiber intake should be considered when counseling patients about the management of blood glucose concentrations.

Adolescent↗

Fetal weight and progression of diabetic retinopathy.

OBJECTIVE: To test the hypothesis that progression of diabetic retinopathy in pregnancy is associated with reduced fetal growth and related neonatal morbidity. METHODS: Women with type 1 diabetes (n = 205) were enrolled before 14 weeks' gestation in a prospective study of diabetes in pregnancy and treated with intensive insulin therapy. They had serial ophthalmologic evaluations before 20 weeks' gestation and in late gestation or postpartum. Subjects were divided into two groups based on whether retinopathy progressed (progression group) or remained unchanged (no progression group). RESULTS: Retinopathy progressed in 59 of 205 women (29%) and was associated with advanced White classification (P =.001): three (5%) were class B, 14 (23%) class C, 24 (41%) class D, and 18 (30%) class F-RF. Reduced fetal growth was associated with progression of retinopathy. Mean birth weight was lower (P =.02), and more infants were small for gestational age (P =.02) and had low birth weights (P =.02) in the progression group. More large-for-gestational-age infants were noted in the no-progression group (P =.04). Birth weight percentile distributions showed a shift of the curve to the left in the progression group (P =.03). There were no differences in gestational age at delivery, macrosomia, preterm delivery, respiratory distress syndrome, neonatal hypoglycemia, or neonatal death. Small for gestational age was associated with chronic hypertension (odds ratio [OR] 6.4; 95% confidence interval [CI] 1.5, 27.9) and retinopathy progression (OR 4.7; 95% CI 1.2, 23.8). CONCLUSION: Development and progression of diabetic retinopathy during pregnancy were associated with reduced fetal growth manifested as increased rate of small-for-gestational-age and low-birth-weight infants.

Adult↗

The Preterm Prediction Study: association between cervical interleukin 6 concentration and spontaneous preterm birth. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.

OBJECTIVE: The aim of this study was to determine the interrelationship between cervical concentration of interleukin 6 and detection of fetal fibronectin and other risk factors for spontaneous preterm birth. STUDY DESIGN: All patients with spontaneous preterm birth at <35 weeks' gestation (case patients; n = 125) and subjects matched for race, parity, and center delivered at > or = 37 weeks' gestation (n = 125; control subjects) were selected from women enrolled in the National Institute of Child Health and Human Development's Preterm Prediction Study. Interleukin 6 concentrations were determined by enzyme-linked immunosorbent assay in cervical swabs obtained at 22 weeks' to 24 weeks 6 days' gestation. Cutoffs to define an elevated interleukin 6 concentration included the 90th and 95th percentiles for control subjects (>305 and >538 pg/mL, respectively). RESULTS: The mean (+/-SD) interleukin 6 concentration was significantly higher in case patients than in control subjects (212 +/- 339 vs 111 +/- 186 pg/mL; P = .008). With either cutoff value elevated interleukin 6 concentration was significantly associated with spontaneous preterm birth (90th percentile, 20% vs 9.6%; P = .02; 95th percentile, 12% vs 4.8%; P = .04). Cervical interleukin 6 levels were highest within 4 weeks of delivery, and the trend continued until term. Elevated interleukin 6 concentration was not significantly associated with bacterial vaginosis, maternal body mass index <19.8 kg/m2, or a short cervix (< or = 25 mm), but it was significantly associated with a positive cervicovaginal fetal fibronectin test result (90th percentile, odds ratio, 5.5; 95% confidence interval, 2.6-11.9; 95th percentile, odds ratio, 5.3, 95% confidence interval, 2.1-12.9). The mean interleukin 6 concentration among women with a positive fibronectin test result was 373 +/- 406 pg/mL; that among women with a negative fetal fibronectin test result was 130 +/- 239 pg/mL (P = .001). In a regression analysis that adjusted for risk factors significantly associated with spontaneous preterm birth in this population (positive fetal fibronectin test result, body mass index <19.8 kg/m2, vaginal bleeding in the first or second trimester, previous spontaneous preterm birth, and short cervix) elevated cervical interleukin 6 concentration was not independently associated with spontaneous preterm birth (odds ratio, 1.8; 95% confidence interval, 0.8-4.3). CONCLUSIONS: At 24 weeks' gestation cervical interleukin 6 concentration in women who subsequently had a spontaneous preterm birth at <35 weeks' gestation was significantly elevated relative to those who were delivered at term. The association was particularly strong within 4 weeks of testing. A positive fetal fibronectin test result was strongly associated with elevated cervical interleukin 6 concentration, but bacterial vaginosis was not.

Case-Control Studies↗

Occupational fatigue and preterm premature rupture of membranes. National Institute of Child Health and Human Development Maternal-Fetal Medicine, Units Network.

OBJECTIVE: The aim of this study was to prospectively determine the relationship between occupational fatigue and spontaneous preterm delivery segregated into the etiologically distinct categories of spontaneous preterm labor, preterm premature rupture of membranes, and indicated preterm delivery. STUDY DESIGN: A total of 2929 women with singleton pregnancies at 22 to 24 weeks' gestation were enrolled in a multicenter (10 sites) Preterm Prediction Study. Patients reported the number of hours worked per week and answered specific questions designed to determine the following 5 sources of occupational fatigue described by Mamelle et al: posture, work with industrial machines, physical exertion, mental stress, and environmental stress. Fatigue was quantified (0-5 index) according to the number of these sources positively reported. Simple and Mantel-Haenszel chi2 tests were used to test the univariate association and hypothesis of a linear trend between sources of occupational fatigue and spontaneous preterm delivery. Covariables were considered by multivariate logistic regression analysis. Women who did not work outside the home were considered separately from those who worked but did not report any sources of occupational fatigue. RESULTS: Each source of occupational fatigue was independently associated with a significantly increased risk of preterm premature rupture of membranes among nulliparous women but not among multiparous women. The risk of preterm premature rupture of membranes increased (P = .002) with an increasing number of sources of occupational fatigue-not working outside the home, 2.1%; working but not reporting fatigue, 3.7%; working with 1 source of fatigue, 3.2%; working with 2 sources of fatigue, 5.2%; working with 3 sources of fatigue, 5.1%; and working with 4 or 5 sources of fatigue, 7.4%. There was also a significant relationship (P = .01) between preterm premature rupture of membranes and an increasing number of hours worked per week among nulliparous women. Neither spontaneous preterm labor nor indicated preterm delivery was significantly associated with occupational fatigue among either nulliparous or multiparous women. CONCLUSION: The occupational fatigue index of Mamelle et al discriminated a group of nulliparous women at increased risk for preterm premature rupture of membranes. The relationship between preterm premature rupture of membranes and occupational fatigue or hours worked may provide guidelines according to which nulliparous women and their employers can be advised.

Adolescent↗

The preterm prediction study: can low-risk women destined for spontaneous preterm birth be identified?

OBJECTIVE: Half of all preterm births occur in women without clinical risk factors. Our goal was to assess fetal fibronectin assay, Bishop score, and cervical ultrasonography as screening tests to predict which low-risk pregnancies will end in preterm birth. STUDY DESIGN: We performed a secondary analysis of data collected at 22 to 24 weeks' gestation from low-risk subjects enrolled in the Preterm Prediction Study, an observational study of risk factors for preterm birth conducted by the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Analysis was limited to primigravid women and to women who did not have a history of preterm birth or spontaneous pregnancy loss at <20 weeks' gestation. Bishop score (> or =4), fetal fibronectin level (> or =50 ng/mL), and cervical length (< or =25 mm) at 24 weeks' gestation were evaluated alone and in sequence as tests to predict spontaneous delivery before 35 weeks' gestation. RESULTS: Of the 2929 subjects enrolled in the original study, 2197 (1207 primigravid women and 900 low-risk multiparous women) met criteria for this analysis. There were 64 spontaneous births before 35 weeks' gestation (3.04%). All three tests were significantly related to birth before 35 weeks' gestation (high Bishop score: relative risk, 3.6; 95% confidence interval, 2.1-6.3; fetal fibronectin detection: relative risk, 8.2; 95% confidence interval, 4.8-13.9; short cervical length: relative risk, 6.9; 95% confidence interval, 4.3-11.1). However, the sensitivities of the tests alone were low (23.4% for high Bishop score, 23.4% for fetal fibronectin detection, and 39.1% for short cervix), as were the sensitivities for Bishop score followed by cervical ultrasonography (14.1%) and fetal fibronectin assay followed by cervical scan (15.6%). CONCLUSION: In the setting of low-risk pregnancy, fetal fibronectin assay and cervical ultrasonography have low sensitivity for preterm birth before 35 weeks' gestation. Sequential screening with Bishop score or fetal fibronectin assay followed by cervical ultrasonography further decreased sensitivity to only 15% among low-risk women.

Cervix Uteri↗

Antiphospholipid antibodies in women at risk for preeclampsia.

OBJECTIVE: The aim of this study was to determine whether positive results of tests for any of 5 antiphospholipid antibodies are associated with recurrent preeclampsia among women with a history of preeclampsia in a previous pregnancy. STUDY DESIGN: Second-trimester serum samples were obtained from 317 women with preeclampsia in a previous pregnancy who were being followed up in a prospective treatment trial. The serum samples were measured by enzyme-linked immunoassay for immunoglobulin G and immunoglobulin M antibodies against 5 phospholipids. Positive results were analyzed with regard to preeclampsia, severe preeclampsia, intrauterine growth restriction, and preterm delivery. RESULTS: Sixty-two of the 317 women (20%) had recurrent preeclampsia develop, 19 (6%) had severe preeclampsia, and 18 (5.8%) were delivered of infants with growth restriction. Positive results of tests for immunoglobulin G or immunoglobulin M antiphospholipid antibodies were not associated with recurrent preeclampsia. Positive results for immunoglobulin G or immunoglobulin M antibodies at the 99th percentile were also not associated with preterm delivery. Positive results at the 99th percentile for immunoglobulin G antiphosphatidylserine antibody were associated with severe preeclampsia, and positive results at the 99th percentile for immunoglobulin G anticardiolipin, antiphosphatidylinositol, and antiphosphatidylglycerol antibodies were associated with intrauterine growth restriction. The positive predictive values for these outcomes all were approximately 30%. CONCLUSION: Positive results of testing for antiphospholipid antibodies in the second trimester were not associated with recurrent preeclampsia among women at risk because of a history of preeclampsia. Positive results for immunoglobulin G antiphosphatidylserine antibody were associated with severe preeclampsia, and positive results for immunoglobulin G anticardiolipin, antiphosphatidylinositol, and antiphosphatidylglycerol antibodies were associated with intrauterine growth restriction. However, the positive predictive values for all these associations were modest. Testing for antiphospholipid antibodies during pregnancy is of little prognostic value in the assessment of the risk for recurrent preeclampsia among women with a history of preeclampsia.

Adult↗

The Preterm Prediction Study: toward a multiple-marker test for spontaneous preterm birth.

OBJECTIVE: The Preterm Prediction Study evaluated 28 potential biologic markers for spontaneous preterm birth in asymptomatic women at 23 to 24 weeks gestational age. This analysis compares those markers individually and in combination for an association with spontaneous preterm birth at <32 and <35 weeks gestational age. STUDY DESIGN: With the use of a nested case-control design from an original cohort study of 2929 women, results of tests from 50 women with a spontaneous preterm birth at <32 weeks and 127 women with a spontaneous preterm birth at <35 weeks were compared with results from matched-term control subjects. RESULTS: In the univariate analysis, the most potent markers that are associated with spontaneous preterm birth at <32 weeks by odds ratio were a positive cervical-vaginal fetal fibronectin test (odds ratio, 32.7) and <10th percentile cervical length (odds ratio, 5.8), and in serum, >90th percentiles of alpha-fetoprotein (odds ratio, 8.3) and alkaline phosphatase (odds ratio, 6.8), and >75th percentile of granulocyte colony-stimulating factor (odds ratio, 5.5). Results for spontaneous preterm birth at <35 weeks were generally similar but not as strong. Univariate and multivariate logistic regression analyses demonstrated little interaction among the tests in their association with spontaneous preterm birth. Combinations of the 5 markers were evaluated for their association with <32 weeks spontaneous preterm birth. Ninety-three percent of case patients had at least 1 positive test result versus 34% of control subjects (odds ratio, 24.0; 95% CI, 6.4-93.4). Among the case patients, 59% had >or=2 positive test results versus 2.4% of control subjects (odds ratio, 56.5; 95% CI, 7.1-451.7). If a cutoff of 3 positive test results was used, 20% of case patients and none of the control subjects had positive test results (P < .002). With the use of only the 3 serum tests (alkaline phosphatase, alpha-fetoprotein, and granulocyte colony-stimulating factor), any positive test identified 81% of cases versus 22% of control subjects (odds ratio, 14.7; 95% CI, 5.0-42.7). For spontaneous preterm birth at <35 weeks gestation, any 2 positive tests identified 43% of cases and 6% of control subjects (odds ratio, 11.2; 95% CI, 4.8-26.2). CONCLUSION: Overlap among the strongest biologic markers for spontaneous preterm birth is small. This suggests that the use of tests such as maternal serum alpha-fetoprotein, alkaline phosphatase, and granulocyte colony-stimulating factor as a group or adding their results to fetal fibronectin test and cervical length test results may enhance our ability to predict spontaneous preterm birth and that the development of a multiple-marker test for spontaneous preterm birth is feasible.

Alkaline Phosphatase↗

Pregnant adolescent and adult women have similarly low intakes of selected nutrients.

OBJECTIVE: To examine the dietary intake of pregnant adolescents during the second and third trimester of pregnancy, and to compare their nutrient intake with that of pregnant adults. DESIGN: Two 7-day food records (14 days) from subjects participating in a larger randomized clinical calcium trial: the first at 19 to 21 weeks and the second between 29 and 31 weeks gestation. Intake of energy and selected nutrients were calculated and compared with dietary standards. SUBJECTS/SETTING: Fifty-nine pregnant adolescents and 97 pregnant adults recruited from prenatal clinics at a metropolitan university hospital. STATISTICAL ANALYSES: Two sample t tests, equality of variances, and repeated measures (analysis of variance). RESULTS: There was no difference in mean nutrient intakes between the second and third trimesters. Using two 7-day food records, we found mean intakes for energy, iron, zinc, calcium, magnesium, folate, and vitamins D and E to be below recommended standards in both groups. Other nutrients examined met or exceeded reference values. Total daily intakes for energy and 11 nutrients were significantly higher in the adolescent compared to the adult diets (P < .05). These differences were not evident when nutrient values were corrected for energy, indicating that increased energy intake in the teen-aged population was contributed by nutrient-dense foods. APPLICATIONS: This study indicates the need for continued dietary monitoring of pregnant adolescents and pregnant adults, including nutrition guidance that stresses food sources of calcium, magnesium, zinc, iron, fiber, folate, and vitamins D and E, the nutrients found deficient in their diets.

Adolescent↗