Changing patterns in medication prescription for gestational diabetes during a time of guideline change in the USA: a cross-sectional study.

OBJECTIVE: To define patterns of prescription and factors associated with choice of pharmacotherapy for gestational diabetes mellitus (GDM), namely metformin, glyburide and insulin, during a period of evolving professional guidelines. DESING: Cross-sectional study. SETTING: US commercial insurance beneficiaries from Market-Scan (late 2015 to 2018). STUDY DESIGN: We included women with GDM, singleton gestations, 15-51 years of age on pharmacotherapy. The exposure was pharmacy claims for metformin, glyburide and insulin. MAIN OUTCOMES: Pharmacotherapy for GDM with either oral agent, metformin or glyburide, compared with insulin as the reference, and secondarily, consequent treatment modification (addition and/or change) to metformin, glyburide or insulin. RESULTS: Among 37 762 women with GDM, we analysed data from 10 407 (28%) with pharmacotherapy, 21% with metformin (n = 2147), 48% with glyburide (n = 4984) and 31% with insulin (n = 3276). From late 2015 to 2018, metformin use increased from 17 to 29%, as did insulin use from 26 to 44%, whereas glyburide use decreased from 58 to 27%. By 2018, insulin was the most common pharmacotherapy for GDM; metformin was more likely to be prescribed by 9% compared with late 2015/16, but glyburide was less likely by 45%. Treatment modification occurred in 20% of women prescribed metformin compared with 2% with insulin and 8% with glyburide. CONCLUSIONS: Insulin followed by metformin has replaced glyburide as the most common pharmacotherapy for GDM among a privately insured US population during a time of evolving professional guidelines. Further evaluation of the relative effectiveness and safety of metformin compared with insulin is needed. TWEETABLE ABSTRACT: Insulin followed by metformin has replaced glyburide as the most common pharmacotherapy for gestational diabetes mellitus in the USA.

Bacterial infection promotes DNA hypermethylation.

Maternal oral infection, caused by bacteria such as C. rectus or P. gingivalis, has been implicated as a potential source of placental and fetal infection and inflammatory challenge, which increases the relative risk for pre-term delivery and growth restriction. Intra-uterine growth restriction has also been reported in various animal models infected with oral organisms. Analyzing placental tissues of infected growth-restricted mice, we found down-regulation of the imprinted Igf2 gene. Epigenetic modification of imprinted genes via changes in DNA methylation plays a critical role in fetal growth and development programming. Here, we assessed whether C. rectus infection mediates changes in the murine placenta Igf2 methylation patterns. We found that infection induced hypermethylation in the promoter region-P0 of the Igf2 gene. This novel finding, correlating infection with epigenetic alterations, provides a mechanism linking environmental signals to placental phenotype, with consequences for development.

Use of prophylactic antibiotics in women with previable prelabor rupture of membranes.

OBJECTIVE: To measure the effect of prophylactic antibiotics given at time of previable prelabor rupture of membranes (PROM) on latency. METHODS: Single center, retrospective cohort study of singleton pregnancies with previable (<23 0/7weeks) PROM. Antibiotics were given at clinician discretion. The primary outcome was latency, defined as duration of time between previable PROM and delivery. Secondary outcomes included delivery at ≥ 23weeks, infant survival, and maternal morbidity. Bivariate analysis compared maternal covariates between women who did and did not receive antibiotics. Antibiotic effect on latency was modeled using a Cox proportional hazards ratio. RESULTS: 213 women with previable PROM were identified; 77 (36%) remained pregnant and thus were included in this analysis. Forty (52%) of 77 received antibiotics. Compared to women who did not receive antibiotics, those who did had PROM at a later median (IQR) estimated gestational age, EGA, (22.2weeks [20.7, 22.5] vs. 19.3weeks [18, 20.7], p < 0.01). Median (IQR) latency was not different between women who did and did not receive antibiotics (2.2 [0.7, 3.9] vs. 1.5 [0.5, 4.6] weeks, p = 0.49). More infants survived to discharge among women who received antibiotics compared to those who did not [17(43%) vs. 3(8%), p < 0.01]. When adjusted for EGA at PROM, antibiotics were associated with longer latency (HR 0.57 [95% CI 0.33, 0.97], p = 0.01). Antibiotic use was not associated with differences in maternal morbidity. CONCLUSION: After adjusting for EGA at PROM, antibiotic receipt was associated with longer latency. Larger prospective studies are needed to define the utility of prophylactic antibiotics in previable PROM.

Hemostatic alterations with exercise conditioning in NIDDM.

Various parameters of coagulation and fibrinolysis were measured in 13 men (aged 54 +/- 3 yr) with non-insulin-dependent diabetes mellitus (NIDDM) before and after 12-14 wk of exercise training. Subjects exercised for 30 min 3 times/wk at 70% of maximum O2 consumption (VO2max). Training increased VO2max by 12.5% but did not alter body weight, relative body fat, blood pressure, cholesterol, triglycerides, or high-density lipoprotein cholesterol. Slight downward trends were apparent for fasting glucose and insulin, but glycosylated hemoglobin was unchanged. There were no changes in coagulation parameters of plasminogen, hematocrit, or alpha 2-antiplasmin. Plasma fibrinogen (303 +/- 24.2 vs. 256 +/- 12.3 mg/dl) and fibronectin (380 +/- 41.9 vs. 301 +/- 22.2 micrograms/ml) were significantly reduced (P less than 0.02) by exercise conditioning. Three assays of fibrinolytic activity (tissue plasminogen activator, euglobulin lysis time, and an isotopic measure of fibrinolysis) confirmed that neither basal fibrinolysis nor the fibrinolytic responses to venous occlusion and maximal exercise were significantly altered. Exercise conditioning may have antithrombotic effects in NIDDM by reducing plasma fibrinogen and fibronectin. Although the significance of the fall in fibronectin awaits further studies, the reduction in plasma fibrinogen gives a rationale for the use of exercise training in men with NIDDM.

Lost in translation? English- and Spanish-speaking women's perceptions of gestational weight gain safety, health risks and counseling.

OBJECTIVE: To determine English- and Spanish-speaking women's perceptions on gestational weight gain (GWG) counseling. STUDY DESIGN: We administered a written survey to 279 pregnant women regarding GWG counseling and knowledge. We compared English- and Spanish-speaking women's responses using X(2)-tests and logistic regression analyses. RESULT: Seventy-four (27%) women completed the survey in Spanish and 205 (73%) in English. More Spanish compared with English speakers did not know if their provider recommended weight gain goals (26% vs 10%, odds ratio (OR) 3.2, confidence interval (CI) 1.5 to 6.5); if there are risks to excessive GWG for mother (27% vs 11%, OR 3.1, CI 1.5 to 6.4) or infant (38% vs 16%, OR 3.3, CI 1.7 to 6.3); or if exercise (15% vs 1%, OR 12.1, CI 3.0 to 69.1) or weight loss (35% v 12%, OR 4.0, CI 2.0 to 8.0) were safe during pregnancy. CONCLUSION: Significant differences exist between Spanish- and English-speaking women's perception of GWG counseling, which may be due to language or cultural barriers.

Extracellular superoxide dismutase localization and activity within the human placenta.

Maintenance of low vascular tone within the placenta is mediated by nitric oxide (NO). The half-life of NO is very short, as superoxide anion (O2-) rapidly inactivates NO to form peroxynitrite. Superoxide dismutases compete with NO for O2-. By scavenging O2-, superoxide dismutase promotes the vasodilatory action of NO. Extracellular superoxide dismutase (EC-SOD) is present in high concentrations within the extracellular matrix of systemic arteries and has been proposed to mediate vascular smooth muscle tone by increasing NO bioavailability. The localization and activity of EC-SOD within the human placenta has not been determined. Placental EC-SOD may be involved in placental vascular tone, and abnormal activity may lead to pre-eclampsia secondary to increased O2--mediated inactivation of NO. To investigate this possibility, the activity and localization of human placental EC-SOD was determined in normal women, and then compared to pre-eclamptic women. Placental EC-SOD localized within the villous extracellular matrix around arterioles, and there were no differences in distribution between normal and pre-eclamptic women. There were no differences in placental EC-SOD activity between normal and pre-eclamptic subjects in either center (33.7+/-4.1 versus 33.1+/-2.5, P=0.6), or peripheral (34.3+/-5.6 versus 34.0+/-3.5, P=0.9) samples. EC-SOD localization around villous vessels suggests that EC-SOD serves potentially to protect the fetal vasculature from O2-, in both normal and pre-eclamptic pregnancies. Placental EC-SOD distribution and activity is not different between pre-eclamptic and normal women, suggesting that EC-SOD is not involved in the vascular changes seen in pre-eclampsia.

Maternal serum granulocyte-colony stimulating factor in preterm birth with subclinical chorioamnionitis.

Preterm birth has been linked with intrauterine infection and inflammation. Serum and amniotic fluid markers of inflammation, such as interleukin-1 (IL-1), IL-6, and granulocyte-colony stimulating factor (G-CSF), have been associated with clinical chorioamnionitis and preterm delivery. As G-CSF regulates the production and maturation of neutrophils, we sought to determine if maternal serum G-CSF levels are elevated in patients with preterm birth with subclinical histologic chorioamnionitis. Maternal serum G-CSF levels were significantly different among five groups of women studied (P < .001, Kruskall-Wallis test), and were highest in subjects with preterm labor who delivered preterm (P < .05, Mann-Whitney U test). Among women with preterm labor who delivered preterm, maternal serum G-CSF levels were significantly higher if histologic chorioamnionitis was present than when histologic evidence of infection was not present (P = 0.04, Mann-Whitney U test). Intrauterine infection may cause a local inflammatory process and initiate preterm labor. This inflammatory response may include production of G-CSF, which would enter the circulation and stimulate the migration of neutrophils to the site of infection. Our data support this concept, as maternal serum G-CSF is elevated with subclinical infection in association with preterm birth.

Antepartum or postpartum isoniazid treatment of latent tuberculosis infection.

OBJECTIVE: To compare health outcomes and costs of different strategies for treatment of latent tuberculosis infection in pregnancy. METHODS: Using a Markov decision-analysis model, the following three strategies were evaluated for treatment of latent tuberculosis infection in pregnancy, defined as positive tuberculin skin reaction of 10 mm or greater and negative chest radiograph: no treatment, antepartum isoniazid administration, in which women were given 300 mg of isoniazid with pyridoxine beginning at 20 weeks' gestation for 6 months; and postpartum isoniazid, in which women were given isoniazid and pyridoxine for 6 months after delivery. Sensitivity analyses were performed for a wide range of probability and cost estimates, and considered discount rates. RESULTS: Under base-case assumptions, the fewest cases of tuberculosis within the cohort occurred with antepartum treatment (1400 per 100,000) compared with no treatment (3300 per 100,000) or postpartum treatment (1800 per 100,000). Antepartum treatment resulted in a marginal increase in life expectancy due to the prevented cases of tuberculosis, despite more cases of isoniazid-related hepatitis and deaths, compared with no treatment or postpartum treatment. Antepartum treatment was the least expensive. Only if the case-fatality rate for tuberculosis was tenfold lower than the base-case and the risk of fatal hepatitis tenfold higher did antepartum treatment become the least advantageous strategy. CONCLUSION: Rather than delaying treatment until postpartum, consideration for antepartum treatment of latent tuberculosis during pregnancy should be given. If isoniazid is not administered antepartum, then efforts to improve postpartum compliance should be instituted, as either antepartum or postpartum treatment is better than no treatment.

A randomized controlled trial of the effect of third-trimester calcium supplementation on maternal hemodynamic function.

OBJECTIVE: To determine the effect of third-trimester calcium supplementation on maternal hemodynamic function. METHODS: Pregnant women were randomized to receive either 1.5 g of elemental calcium or placebo for 6 weeks during the third trimester. Using Doppler technique, maternal hemodynamic characteristics were measured at baseline, at 2 hours after the first dose of study drug, and at the completion of 6 weeks. Serum, dietary, and urinary calcium levels were also assessed. Power calculation indicated the need to study ten subjects in each group to detect a 1.2 L (20%) difference in cardiac output between groups, assuming a mean of 6.2 +/- 1.0 L/minute. Data were analyzed by analysis of variance for repeated measures, Student t test, Mann-Whitney U test, and Fisher exact test. RESULTS: Twenty-three women enrolled, and 18 completed the study. There were no statistically significant differences in demographic characteristics or in serum, dietary, or urinary calcium levels between the two groups. There were also no statistically significant differences in hemodynamic function over time within the calcium supplementation or placebo group (P > .05; analysis of variance for repeated measures). After 6 weeks, there were no significant differences between the calcium- and placebo-treated subjects in any hemodynamic measurement. Specifically, there was not a statistically significant difference in cardiac output (7.3 +/- 1.2 L/minute versus 8.0 +/- 0.9 L/minute; P = .09) between the calcium- and placebo-treated groups. CONCLUSION: These findings suggest that third-trimester calcium supplementation does not significantly alter cardiac output. The mechanism by which calcium supplementation lowers blood pressure remains to be elucidated.

Placental pathology in patients using cocaine: an observational study.

OBJECTIVE: Although retroplacental hemorrhage is a major cause of fetal death, its etiology often remains obscure. In some reports, cocaine use by pregnant women has been associated with retroplacental hemorrhage and clinical abruptio placentae. This study was designed to assess the occurrence of chorionic villus hemorrhage, an entity shown recently to be associated with retroplacental hemorrhage, in the placentas of cocaine users. METHODS: Twenty-nine placentas from cocaine users and 15 placentas from drug-free controls, as determined by questionnaire and urine toxicology screen, were examined prospectively, and pathological findings documented. The prevalence of retroplacental hemorrhage, chorionic villus hemorrhage, edema, chorioamnionitis, funisitis, infarction, fetal vessel thrombosis, and intervillus hemorrhage was examined in the two groups. RESULTS: Chorioamnionitis was the most frequent finding in both groups (58% of cocaine users, 66% of controls). Edema of moderate severity or greater was found only in the cocaine-using group (17%). The prevalence of chorionic villus hemorrhage among women using cocaine also was 17%. CONCLUSION: Cocaine use during pregnancy may be associated with chorionic villus hemorrhage and villus edema, even in the absence of clinical abruptio placentae. The relationship between abnormal placental morphology and adverse perinatal outcomes remains to be determined.

Umbilical venous D-dimer concentrations with and without labor.

OBJECTIVE: To determine if labor activates the fetal fibrinolytic system. METHODS: A total of 59 umbilical venous blood samples were collecting following vaginal delivery at term (n = 20), cesarean delivery following labor at term (n = 12), vaginal delivery before term (n = 18), and cesarean delivery without labor (n = 9). D-dimer concentrations, a sensitive marker of fibrinolysis, were measured by enzyme-linked immunosorbent assay, and compared between groups by Kruskel-Wallis and Mann Whitney U tests, with significance defined as P < .05. RESULTS: There were no significant differences in median D-dimer concentrations between newborns delivered vaginally or by cesarean after term labor or preterm labor. There were significant differences in median umbilical venous D-dimer concentrations in subjects delivered vaginally or by cesarean after term or preterm labor compared with term subjects without labor delivered by cesarean (427, 773, and 326 versus 87 ng/mL, P = .01). CONCLUSION: Elevation of umbilical plasma D-dimer concentrations in laboring patients suggests activation of fetal fibrinolysis before delivery.

Urinary interleukin-8 with asymptomatic bacteriuria in pregnancy.

OBJECTIVE: To evaluate urinary interleukin-8 (IL-8), an inflammatory cytokine, as a screening method for detecting asymptomatic bacteriuria in pregnancy. METHODS: Clean-catch urine samples from 200 pregnant women undergoing screening for asymptomatic bacteriuria were evaluated by urine culture, urine dipstick analysis, and measurement of IL-8. Interleukin-8 levels were measured by a chemiluminescent immunoassay (Immulite IL-8, Diagnostic Products Corp., Los Angeles, CA), and a receiver operating characteristic curve was used to determine the optimal cutoff point. Asymptomatic bacteriuria was defined as at least 100,000 colony-forming units of a single organism per mL. Dipstick testing included nitrite assessment as positive or negative and leukocyte esterase as negative, trace, 1+, 2+, or 3+. Dipstick testing was considered positive if nitrite was positive or leukocyte esterase was trace or greater. Sensitivities, specificities, positive and negative predictive values were determined for urinary leukocyte esterase and nitrite and compared with those of IL-8. chi(2) and Mann-Whitney U tests were used for statistical analyses. RESULTS: Twenty women were identified with asymptomatic bacteriuria by urine culture. The median urinary IL-8 levels for women with and without asymptomatic bacteriuria were 356 pg/mL and 125 pg/mL, respectively (P <.01, Mann-Whitney U test). Using an optimal cutoff point of 264 pg/mL, IL-8 had a sensitivity, specificity, positive and negative predictive value of 70%, 67%, 19%, and 95% for predicting asymptomatic bacteriuria. Urine dipstick analysis with either a positive leukocyte esterase or nitrite had a sensitivity, specificity, positive and negative predictive value of 45%, 62%, 12%, and 91%, respectively, for detecting asymptomatic bacteriuria. The differences between these testing methods were not statistically significant. CONCLUSION: Urinary interleukin-8 is not an acceptable screening method for asymptomatic bacteriuria in pregnancy because it fails to detect 30% of women with this condition.

Repeated fetal betamethasone treatment and birth weight and head circumference.

OBJECTIVE: To assess the effect of repeated courses of betamethasone on birth weight and head circumference. METHODS: We conducted a historical cohort study of inpatients receiving betamethasone therapy over 5 years. We compared birth weights and head circumferences of infants whose mothers received one course of betamethasone with those of infants whose mothers received multiple courses. Multiple regression analysis was used to adjust for potential confounding variables. Sufficient power (80%) existed to detect a 20% difference between the groups (alpha = 0.05). RESULTS: Mean birth weights (+/-SD) were 1717 +/- 707 g in the single-course group (n = 107) and 1783 +/- 647 g in the multiple-course group (n = 45) (P =.59, Student t-test). Mean head circumference was 28.2 +/- 3.6 cm in the single-course group and 29.2 +/- 2.9 cm in the multiple-course group (P =.15, Student t-test). In regression analysis, birth weights (1757 g and 1752 g) and head circumferences (28.5 cm and 29.0 cm) did not differ significantly different between the single-course and multiple-course groups. CONCLUSION: Multiple courses of betamethasone do not reduce birth weight or head circumference in neonates compared with single-course therapy.

Bacteremia shortly after placental separation during cesarean delivery.

OBJECTIVE: To assess frequency, risk factors, and microbiology of bacteremia within 15 minutes of placental separation during cesarean delivery. METHODS: Ninety-three women undergoing cesarean delivery after a minimum of 4 hours of labor or ruptured membranes were compared with 26 women not in labor undergoing cesarean. Blood cultures for aerobic and anaerobic bacteria were obtained within 15 minutes of delivery of the placenta and before prophylactic antibiotic administration. Chorioamnionic membranes were also cultured. Demographic, labor, delivery, and postpartum characteristics were abstracted from the medical record. RESULTS: Bacteremia was detected in 13 (11%) of 119 women. Bacteremia occurred in 13 (14%) of 93 women after labor or rupture of membranes compared with zero of 26 women not in labor (P = .02). Isolates included group B streptococcus (n = 5), Gardnerella vaginalis (n = 5), Streptococcus pneumoniae (n = 1), Peptostreptococcus sp (n = 1), and mixed flora of Prevotella bivia, G vaginalis, and viridans streptococci (n = 1). Bacteremia was associated with earlier median gestational age, lower median birth weight, and a positive chorioamnionic membrane culture. After adjustment for gestational age, intrauterine monitoring was also significantly associated with bacteremia. CONCLUSION: Bacteremia was common after labor in this population, especially in preterm deliveries and those with positive chorioamnionic-placental culture. Many of the isolates are capable of causing endocarditis. Appraisal of the risk of bacteremia and the risk of bacterial endocarditis should be made in individual patients to assess the need for antibiotic prophylaxis.

Delivery of the nonvertex second twin: a review of the literature.

Twin gestations comprise approximately 1 percent of all pregnancies (1), and are associated with increased perinatal morbidity and mortality, mainly due to the increased incidence of prematurity and growth restriction (2). Hazards of twin delivery can be attributed to malpresentation, most often by the second twin. The vertex-nonvertex presentation occurs in approximately 40 percent of all twins (3, 4). Although there is consensus regarding the safety of vaginal delivery for twins when both are vertex (5), controversy exists over intrapartum management when the second twin is nonvertex. Some investigators advocate cesarean delivery, particularly when the second twin is nonvertex (6), or if the expected birth weight is < 2000 gm (6-8). This review aims to determine whether vaginal delivery of the nonvertex second twin, either by breech extraction or attempted external cephalic version, is associated with increased morbidity or mortality over cesarean delivery.

Nitrofurantoin-induced pulmonary toxicity during pregnancy: a report of a case and review of the literature.

Acute pulmonary reactions to nitrofurantoin are an uncommon side effect of therapy and can cause minor or life-threatening pulmonary dysfunction. Symptoms include fever, chills, cough, pleuritic chest pain, dyspnea. Rarely, pleural effusion and/or pulmonary hemorrhage may occur. Diagnosis is made by clinical suspicion and exclusion of other causes of respiratory compromise. Bronchoalveolar lavage (BAL) may be used to rule out infectious etiologies, and an increase in BAL fluid eosinophils is suggestive of drug-induced toxicity. The acute reaction to nitrofurantoin is believed to be mediated by an immune mechanism. Treatment is mainly discontinuation of the drug, however, corticosteroid therapy is recommended for severe reactions. A chronic reaction associated with long-term treatment with nitrofurantoin has also been reported and causes irreversible pulmonary fibrosis. Nitrofurantoin is commonly used to treat urinary tract infections during pregnancy. Despite the known pulmonary side effects of nitrofurantoin, there is no report of this toxicity occurring in pregnant patients. We present a case of respiratory failure occurring in a woman at 16 weeks' gestation who was being treated with nitrofurantoin for a urinary tract infection.

Influence of the menstrual cycle on systemic diseases.

Physiological changes associated with the menstrual cycle influence the clinical course of some diseases such as bronchial asthma, allergies, anaphylaxis, epilepsy, migraine, dermatoses, and porphyria. Hormonal manipulation can be beneficial in some patients.

Effect of betamethasone on maternal glucose.

OBJECTIVE: To determine the effect of single and multiple betamethasone courses on maternal fasting and postprandial glucose values. STUDY DESIGN: A prospective cohort study was performed in women receiving betamethasone at 24-34 weeks' gestation. Fasting and 1-h postprandial capillary glucose values were obtained daily following betamethasone therapy for hospitalized patients. A control group comprised outpatients who underwent weekly fasting and postprandial assessments for 3 weeks. Fasting and 1-h postprandial capillary glucose values were compared between control and betamethasone patients using an unpaired t test. RESULTS: Thirty-five women received a single course of therapy, 19 received multiple courses and 28 served as controls. Mean fasting glucose values for control patients fell within a narrow range of 81.6 +/- 10.3 to 82.2 +/- 6.4 mg/dl for weeks 1-3. Of women receiving betamethasone, 59% of fasting glucose values were greater than 90 mg/dl as compared to 16% of control fasting values (p < 0.00 1, chi2 test). Mean 1-h postprandial values for control women ranged from 107.7 +/- 15.1 to 112.3 +/- 20.0 mg/dl for weeks 1-3. Mean 1-h postprandial glucose values were < or = 140 mg/dl following one, two or three courses of betamethasone therapy. CONCLUSIONS: Betamethasone resulted in an acute increase in fasting glucose following a single course of betamethasone, whereas two or more courses of therapy resulted in a continuous elevation of fasting glucose values. One-hour postprandial values were not clinically abnormal.

Management and outcome of pregnant women with interstitial and restrictive lung disease.

OBJECTIVE: Our purpose was to describe our experience with management and outcome of restrictive lung disease in pregnancy. STUDY DESIGN: Between 1981 and 1994 nine pregnant women with interstitial and restrictive lung disease were prospectively managed and delivered at the University of Washington Medical Center. RESULTS: Three patients had severe disease, characterized by vital capacity < or = 1.5 L (50% predicted) or diffusing capacity < or = 50% predicted. Five patients had exercise-induced oxygen desaturation, and four required supplemental oxygen. Five patients required corticosteroids. One patient had an adverse outcome; she was delivered at 31 weeks and required mechanical ventilation for 72 hours. All other patients were delivered at or beyond 36 weeks with no adverse intrapartum or postpartum complications. All babies were at or above the 30th percentile for growth. CONCLUSIONS: Restrictive lung disease is tolerated in pregnancy. Exercise intolerance is common and patients may require early oxygen supplementation. Adequate fetal growth can be achieved.

Performance of a commercial polymerase chain reaction test for endocervical Chlamydia trachomatis infection in a university hospital population.

OBJECTIVES: To examine the accuracy of a commercial polymerase chain reaction (PCR) test (Amplicor CTR, Roche Diagnostic Systems, Branchburg NJ) for identification of endocervical chlamydial infections through both laboratory evaluation and among a diverse teaching hospital patient population. METHODS: Testing of reliable threshold inocula and reproducibility were carried out using laboratory stock organisms. Paired endocervical samples from patients with a wide range of indications were tested by PCR and an established culture procedure, and discrepant pairs were further analyzed to determine true results. RESULTS: Laboratory evaluation suggested that one copy of target DNA from a viable organism consistently yielded a positive result, and test reproducibility was very good, with an overall coefficient of variation of 15%. Compared to true results in 1,588 paired clinical samples from 1,489 women with a 10% prevalence of infection, the PCR test and culture yielded respective sensitivities of 87.4% and 78.0%, and negative predictive values of 98.6% and 97.6%. Specificity and positive predictive value for both tests were 100%. Cost per specimen was nearly identical at $18.84 and $18.88 respectively. Polymerase inhibitors and organisms lacking target DNA were not found in false-negative PCR samples. CONCLUSION: This commercial PCR test is accurate, cost-competitive, and much faster than culture for diagnosis of endocervical chlamydia infections in our population of intermediate prevalence of chlamydial infection.