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Background: Garlic has a wide range of actions, including antibacterial, antiviral, antifungal, antiprotozoal and antihelminthic actions. This antiparasitic activity has been attributed to allicin, which is the main constituent of garlic. The aim: is to evaluate the potential therapeutic and/or prophylactic effects of allicin on S. mansoni. Method: Swiss albino mice strain CD1were infected with S. mansoni cercariae and sacrificed 40 days later to acquire the adult worms. These worms were collected by perfusion and placed in RPMI medium 1640 at 37°C before transferring to RPMI media containing 0 (control), 5, 10 and 100µg/ml of allicin, where they were incubated for 48h and monitored during this time to evaluate motility and mortality rate by means of stereomicroscope. Twenty male Swiss albino mice strain CD1were divided into two groups. One group was infected with S. mansoni cercariae and treated with allicin one week post infection. The second group was (control). Results: In vitro incubation of S. mansoni adult worms with allicin, showed a statistically high significant difference in comparison with control non-treated group. All worms showed slow movement after 48 h of incubation at concentration of 100µg/ml. No effect was noticed at allicin concentrations of 10 and 5 µg/ml at the end of the experiment. Administration of allicin to the infected mice had non- significant effect on the worm burden. Conclusion: allicin was effective against adult S. mansoni worms in vitro, but with no significant effect in vivo.

Hymenolepis nana is one of the commonest parasites worldwide especially in children. Praziquantelwas the most effective drug in hymenolepiasis treatment, but with the risk of resistancedevelopment. There was a need for search for drug(s) to overcome this problem. Tamoxifen(an estrogen-receptor modulator), is available, low cost with potential anti-parasitic efficacy.This study assessed the therapeutic effect of tamoxifen drug on mice experimentally infectedmice with H. nana at different developmental stages. Clean laboratory bred mice infected withH. nana eggs were divided into 4 groups according to different schedule of tamoxifen administration(20mg/kg body weight) at the parasite different developmental stages and control one(infected non treated). At the experimental mice were sacrificed and parasitological evaluatedfor worm burden count, their weight, egg count and viability. The results did not show statisticallysignificant effect on worm burden as compared to control one, with the exception of micetreated two days post-infection that showed significant increase in worm burden. There wassignificant decrease in worm weight, egg count and viability as compared to control ones, butwithout difference between different treated groups.

Toxoplasma gondii is an opportunistic protozoan that causes a devastating disease in immunocompromisedindividuals and congenitally infected neonates or children. This study evaluated theefficacy of early Azithromycin treatment of Toxoplasma gondii infected mice with cystogenic Me49 non-virulent strain. Fifty laboratory-bred female Swiss albino mice were divided into 5 groups:G1: Non-Infected, G2: Infected non-treated, G3: Infected and treated by Azithromycin 200mg/kg at 4th day post-infection for 3 days, G4: Infected and treated by Azithromycin 200mg/kg at4th day post-infection for 10 days & G5: Infected and treated by Spiramycin 200mgkg at 4th daypost-infection for 2 weeks, brain cysts’ number, size and histopaholoical changes were assessedafter 3 months. Treatment with Azithromycin for 10 days decreased number and size of braincysts by 70% & 40% respectively without significant difference with Spiramycin treated micethat caused reduction by 74% & 50% respectively. Azithromycin treatment for 3 days caused theleast reduction by 51% & 21% respectively and Azithromycin treatment for 10 days decreasedthe histo-pathological changes in cerebral toxoplasmosis. Azithromycin treatment started at 4thday post-infection was effective than Spiramycin against T. gondii infection with a significant effecton cysts count and size and brain pathological changes. Azithromycin treatment for 10 daysgave better effect than 3 days.

The rapid increase in the ageing population and health conditions are imposing a higher challenge to the health care system that requires multidisciplinary teamwork utilizing coordinated care approach. This study examined the effects of integrated care model on quality of care received by older hospitalized patients in West Bank. A quantitative interrupted time series design (pretest and posttest multiple time series, quasi-experiment design) was used. The study examined the effects of integrated care model on admitted older patients (n=32) in the West Bank measuring ten dimensions of quality of care and four health indicators. There was a significant improvement in the dimensions of quality of care: dimensions: nurses’ communications with patients, physicians’ communications with patients, staff response to patients’ needs, pain management, explanations on medications, amount of information given on discharge plan, patients' area cleanliness, patients' area quietness, rating of the hospital, and willingness to recommend the hospital. Incidence of falls and incidence of pressure ulcer improved after implementing the model, while readmission rate and average length of stay did not improve. This study contributed to the limited body of knowledge related to the effect of integrated care model on hospitalized older patients’ quality of care in Palestine/ West Bank. Integrated care has the potential to improve care outcomes among hospitalized older patients.

Background: Hip pain is a common problem in patients of all ages, attributed to many causes. MRI combined with recent technologic developmentst plays a crucial role in assessment of epiphyseal disorders in great detail without ionizing radiation.Aim of Study: Was to evaluate the diagnostic value of MRI in assessment of non-neoplastic femoral head lesions.Patients and Methods: This study included 40 patients, 22 females (55%) and 18 males (45%), their ages ranged from 4 to 65 years with a mean age of 35 years complaining of hip pain. The most frequently involved age group was the group >30-40 years in both males and females.All patients were clinically evaluated, and then subjected for radiological examination and medical imaging (MRI) for all patients and ultrasonography for 6 patients (5 developmental dysplasia and 1 septic arthritis).Results: Out of forty patients who had performed MRI were classified to: Avascular necrosis; the commonest disease in our study; as it is seen in 12 (30%) patients, followed by; osteoarthritis in 6 (15%) patients, migratory osteoporosis in 4 (10%) patients, septic arthritis in 4 (10%) patients, devel-opmental dysplasia in 5 (12.5%) patients, Perthe's disease in 4 (10%) patients, slipped capital femoral epiphysis in 3 (7.5%) patients and stress fractures in 2 (5%) patients.The final diagnosis achieved through the MRI findings were confirmed by surgical data in 6 patients with avascular necrosis, histopathology in 5 patients (3 septic arthritis and 2 osteoarthritis) and follow-up by clinical, laboratory and other imaging studies in 29 patients.Conclusion: MRI is highly sensitive imaging modality for diagnosis and characterizing of different non-neoplastic femoral head lesions and accurate for assessing the full extent of osseous, chondral and soft tissue abnormalities of the hip joint.

Background: Imaging of laryngeal tumors is crucial for evaluation, preparing, treatment and for ensuring proper follow-up. Computed tomography and magnetic resonance imaging are the main imaging tools. Each modality showed its own advantages for assessment of local, regional or distant staging.Aim of Study: The aim of this study was to evaluate the role of multi slice computed tomography and magnetic reso-nance imaging in diagnosis of laryngeal tumors.Material and Methods: This prospective study included (30) patients in different age groups who were highly suspected with laryngeal tumors or known to be having laryngeal tumor. Patients were referred by Oto Rhino Laryngology (ORL) Department of Tanta University Hospital to the CT Unit & MRI Units of the Diagnostic Radiology & Medical Imaging Department, Tanta University Hospitals. All cases were sub-jected to full history, complete physical examination, radio-logical & medical imaging examination at which all cases were exposed to CT scanning of the neck while only 22 cases of them performed additional MRI examination of the neck. Further endoscopic examination and histopathological corre-lation were done. Data was analyzed by using SPSS.Results: MRI showed higher accuracy than CT as regards to pathological T staging of laryngeal tumors 244 that showed 86.4% for MRI while 66.7% for CT. Both CT and MRI were equal in evaluation of certain areas as anterior commissure and pyriform sinus while MRI showed higher accuracy in evaluation of other laryngeal subsites namely preepiglottic, paraglottic spaces, posterior commissure, epiglottis, vocal cords, thyroid cartilage extralaryngeal spread.and metastatic lymphadenopathy with the total accuracy higher in MRI than in CT.Conclusion: MRI could be considered a helpful diagnostic method for pre and post-therapeutic staging of laryngeal tumors specially early glottic lesions and the combined utility of CT and MRI could help to overcome the disadvantages and improve the accuracy specially about thyroid cartilage assessment and T staging of laryngeal carcinomas.

The aim of the present study was to assess the frequency of intestinal parasitic infection among patients with gastrointestinal tract disorders from the Greater Cairo region, Egypt. In addition, a comparison was made of the accuracy of direct thin and thick smear, formol-ether sedimentation (FEC), centrifugal flotation (CF), and mini-FLOTAC techniques in the diagnosis of infection. Out of 100 patients, the overall prevalence of parasitic infection was 51%. Only 6% had dual infection. Giardia lamblia was the most common parasite (26%), followed by Hymenolepis nana (20%), Entamoeba coli (8%), and Enterobius vermicularis (3%). Except the statistically significant association between E. vermicularis infection and perianal itching and insomnia (P < 0.001), age, gender, and complaints of the examined individuals had no association with prevalence of parasitic infection. Both FEC and CF were equally the most accurate techniques (accuracy = 98.2%, confidence interval [CI] = 0.95–1.0, and κ index = 0.962), whereas the Kato-Katz method was the least accurate (accuracy = 67.5%, CI = 0.57–0.78, and κ index = 0.333). However, mini-FLOTAC-ZnSO4 was the most accurate for diagnosis of helminthic infection, and FEC was more accurate for diagnosis of protozoal infection (accuracy = 100%, CI = 1.0–1.0, and κ index = 1).

Objective To evaluate the role of conventional and functional MRI in diagnosis of breast masses. Patients and methods This study included 34 female patients who presented clinically by breast mass and/or had abnormal sonomammographic findings and referred from General surgery Department for MRI assessment. The MRI results were correlated with pathological results for all cases. Results Those 34 patients were classified pathologically into 21 patients with benign breast lesion (21/34) (61.8%), 10 patients with malignant lesion (29.4%) and 3 patients with high risk lesion (8.8%). The type III intensity curve was the most depicted type in the malignant breast lesion (60%), while type Ia curve was the most depicted type in the benign lesions (61.8%). Out of 25 patients without restricted diffusion; 19 patients showed benign lesions (76%) and out of 9 patients with restricted diffusion; 6 patients showed malignant lesion (66.7%). Out of 17 patients with choline trace; 9 patients were malignant, 5 were benign and 3 were with high risk lesion. Conclusion DCE-MRI of the breast had a higher sensitivity for breast cancer detection and more accurate in delineation of the disease extension. The breast MRI with three parameters (DCE-MRI, DWI, and MRS) increased the diagnostic accuracy of the breast cancer.

Background MRI examination of the rectum has evolved as the standard technique in the assessment of cancer rectum having multiplaner capabilities and high tissue contrast imaging. Aim of the work The aim of this study is to evaluate the role of MRI in assessment of rectal neoplasm. Patients and methods In this work, 42 patients were studied as preoperative evaluation and staging that known to have or highly suspected clinically to have rectal neoplasms. They were subjected to assessment by MRI using pelvic phased array coil with IV contrast (Gadolinium) and rectal gel administration. Results MRI was proved to have high accuracy in the assessment of the rectal wall infiltration and pelvic organ involvement which is about 93% and also has high accuracy in the assessment of peri-rectal lymph nodes involvement which is about 91% as compared to the post-operative pathological results. Conclusion Our study results demonstrate that high resolution MRI has pivotal role in accurate staging of rectal cancer and predicting involvement of the perirectal and pelvic lymph nodes as well as planning of the sphincter sparing surgery.

Objective: To evaluate the efficacy of color Doppler US and tri-phasic CT in discriminating benign from malignant PVT. Patients and methods: This study included 30 patients presented ultrasonically with PVT and referred for color Doppler US and Tri-phasic CT examination for discriminating the benign from malignant PVT. The color Doppler US and tri-phasic CT results were compared and correlated with available histopathological results in the patients who had FNAC. Results: Those 30 patients were classified according to US, Tri-phasic CT, lab., findings into two groups: G.(A) included 16 patients with malignant PVT and G.(B) included 14 patients with benign PVT. Intrathrombus pulsatile flow was depicted in 12 patients with malignant PVT (12/16) (75%), while non-depicted in 14 patients with benign PVT with 100% specificity. On tri-phasic CT, neovascularity and an early arterial enhancement of PVT were depicted in 14 cases with malignant PVT with 87.5% sensitivity and non-depicted in 14 benign cases with PVT with 100% specificity. Conclusion: Distinguishing benign from malignant PVT in patients with HCC is required to determine the management plan. The color Doppler study of PVT should be an essential step in evaluation of patients with HCC. The combination of Color Doppler US and tri-phasic CT is common and essential for more accurate evaluation and differentiation of benign from malignant PVT.

The mite Blomia tropicalis has significant prevalence worldwide. Blo t 5 is a major B. tropicalis allergen that has been associated with sensitization and allergic symptoms in many asthmatic patients. Besides house dust, contaminated foodstuffs are an important source of exposure to B. tropicalis allergens. In this study, a double sandwich enzyme-linked immunosorbent assay (ELISA) using mAb 4D4 and biotinylated mAb 4G9 was done to detect Blo t 5 allergen in different types of raw and processed foods, including wheat, corn, rice, bean, wheat and corn flour, cake, and rusk, which were collected from retail stores in the Nile Delta of Egypt. Out of 88 samples, 38 (43.2%) were positive for Blo t 5 allergen with no significant statistical difference in positivity according to food type. In positive samples, the Blo t 5 concentration ranged from 10 ng/g to 790 ng/g. This study showed that Blo t 5 should be considered as an important allergen that presents a risk to the Egyptian population and should become a routine allergen in the skin prick test to improve the management of allergic disease.

Objective To evaluate the diagnostic possibilities of multidetector computed tomography (MDCT) virtual cystoscopy (V.C.) in evaluation of urinary bladder carcinoma. Patients and methods This study included 55 patients with recent initial conventional cystoscopic (C.C.) assessment (at the outpatient clinics) & revealed bladder mass including the followed up patients for U.BL. mass recurrence who were referred for CT virtual cystoscopic (V.C.) evaluation. All patients underwent conventional cystoscopy within a week after the virtual examination. The virtual image, axial 2D, and C.C. reports were compared to each other and to the obtained histopathological results. Results Out of 93 intravesical masses depicted by C.C., 91 were depicted by V.C. (97.8%). The CT V.C. had higher sensitivity (97.8%) in comparison to that of axial 2D spiral CT (90.3%) in detection of U.BL. masses. V.C. could pass through the narrow neck diverticulae in three cases, while C.C. could not navigate through them. Conclusion C.C. represents the gold standard for diagnosis & local management of U.BL. carcinoma. The results of V.C. & C.C. were comparable in detection, localization & morphology description of U.BL. masses. MDCT V.C. may be alternative or complementary examination where C.C. is difficult to be performed or contraindicated.

To prospectively compare digital cervical score with Bishop score as a predictor of spontaneous preterm delivery before 35 weeks of gestation.Data from a cohort of 2,916 singleton pregnancies enrolled in a multicenter preterm prediction study were available. Patients underwent digital cervical examinations at 22-24 and 26-29 weeks of gestation for calculation of Bishop score and cervical score. Relationships between Bishop score, cervical score, and spontaneous preterm delivery were assessed with multivariable logistic regression analysis, McNemar test, and receiver operating characteristic (ROC) curves to identify appropriate diagnostic thresholds and predictive capability.One hundred twenty-seven of 2,916 patients (4.4%) undergoing cervical examination at 22-24 weeks had a spontaneous preterm delivery before 35 weeks. Eighty-four of the 2,538 (3.3%) reexamined at 26-29 weeks also had spontaneous preterm delivery. Receiver operating characteristic curves indicated that optimal diagnostic thresholds for Bishop score were at least 4 at 22-24 weeks, at least 5 at 26-29 weeks, and less than 1.5 at both examinations for cervical score. At 22-24 weeks, areas under the ROC curve favored Bishop score. At 26-29 weeks, there was no significant difference in areas under the ROC curve; however, a cervical score less than 1.5 (sensitivity 35.7%, false positive rate 4.8%) was superior to a Bishop score of 5 or more (P.001).Both cervical evaluations are associated with spontaneous preterm delivery in a singleton population; however, predictive capabilities for spontaneous preterm delivery were modest among women with low event prevalence. Although Bishop score performed better in the mid trimester, by 26-29 weeks a cervical score less than 1.5 was a better predictor of spontaneous preterm delivery before 35 weeks than a Bishop score of at least 5.

A single course of corticosteroids given to pregnant women at risk for preterm delivery reduces the risks of prematurity-related complications, including the risk of death, respiratory distress syndrome, and intraventricular hemorrhage by 50% or more.1–6 Currently there is near universal use of antenatal corticosteroids in the setting of anticipated preterm delivery. With observations by Liggins and others4,5 that the optimal benefit of antenatal corticosteroids may not last beyond 7 days, the 1994 National Institutes of Health Consensus Development Conference statement called for additional research on the potential benefits and risks of repeated administration of antenatal corticosteroids. A second National Institutes of Health Consensus Development Conference in 2000 specifically examined the question of repeat courses of antenatal corticosteroids, concluding that insufficient risk and benefit data exist to support routine use of repeat courses of antenatal corticosteroid in clinical practice. The use of multiple courses of steroids has been continuously debated7–10 and has been the subject of multicenter trials in the United States, United Kingdom, and Australia.1–3, 11–14 Although there have been proven benefits to using antenatal corticosteroids, there has also been concern over possible fetal and maternal adverse effects, particularly with repeated courses. Possible detrimental fetal effects include neurodevelopmental delay, growth delay, and adrenal suppression. Studies of maternal adverse effects have focused primarily on infection.6 Only a few studies have examined the effect of a single course of antenatal corticosteroids on maternal bone metabolism, and no adverse effects were reported.15, 16 Our study addresses whether repeated courses of antenatal corticosteroids have an effect on maternal bone metabolism, using two markers of bone turnover, the carboxy terminal propeptide of type I procollagen (PICP) and the cross-linked carboxy terminal telopeptide of type I collagen (ICTP). Carboxy terminal propeptide of type I procollagen, an extension propeptide that facilitates collagen polymerization, is a serum marker of bone formation. Crosslinked carboxy terminal telopeptide of type I collagen is released by bone-specific proteases and is a marker of bone resorption. Both PICP and ICTP have been shown to be specific markers for their respective changes in bone in various biochemical studies.17–20 The specific aim of our study was to compare PICP, ICTP, and their ratio between women who received a single compared with multiple courses of antenatal corticosteroids.

Current information on the risk of uterine rupture after cesarean delivery has generally compared the risk after trial of labor to that occurring with an elective cesarean delivery without labor. Because antepartum counseling cannot account for whether a woman will develop an indication requiring a repeat cesarean delivery or whether labor will occur before scheduled cesarean delivery, the purpose of this analysis was to provide clinically useful information regarding the risks of uterine rupture and adverse perinatal outcome for women at term with a history of prior cesarean delivery.Women with a term singleton gestation and prior cesarean delivery were studied over 4 years at 19 centers. For this analysis, outcomes from five groups were studied: trial of labor, elective repeat with no labor, elective repeat with labor (women presenting in early labor who subsequently underwent cesarean delivery), indicated repeat with labor, and indicated repeat without labor. All cases of uterine rupture were reviewed centrally to assure accuracy of diagnosis.A total of 39,117 women were studied. In term pregnant women with a prior cesarean delivery, the overall risk for uterine rupture was 0.32% (125 of 39,117), and the overall risk for serious adverse perinatal outcome (stillbirth, hypoxic ischemic encephalopathy, neonatal death) was 106 of 39,049 (0.27%). The uterine rupture risk for indicated repeat cesarean delivery (labor or without labor) was 7 of 6,080 (0.12%); the risk for elective (no indication) repeat cesarean delivery (labor or without labor) was 4 of 17,714 (0.02%). Indicated repeat cesarean delivery increased the risk of uterine rupture by a factor of 5 (odds ratio 5.1, 95% confidence interval 1.49-17.44). In the absence of an indication, the presence of labor also increased the risk of uterine rupture (4 of 2,721 [0.15%] compared with 0 of 14,993, P.01). The highest rate of uterine rupture occurred in women undergoing trial of labor (0.74%, 114 of 15,323).At term, the risk of uterine rupture and adverse perinatal outcome for women with a singleton and prior cesarean delivery is low regardless of mode of delivery, occurring in 3 per 1,000 women. Maternal complications occurred in 3-8% of women within the five delivery groups.

To compare maternal and neonatal outcomes when primary cesarean delivery is performed in the second stage of labor compared with the first stage.Between January 1, 1999, and December 31, 2000, a prospective observational study of primary cesarean deliveries was conducted at 13 university centers comprising the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. The primary outcomes of interest included a maternal composite (composed of at least one of the following: endometritis, intraoperative surgical complication, blood transfusion, or wound complication) and neonatal composite (which included at least one of the following: Apgar score of 3 or less at 5 minutes, neonatal death, neonatal intensive care unit admission, seizure, delivery room intubation in the absence of meconium, or fetal injury).A total of 11,981 cesarean deliveries were available for analysis: 9,265 were performed in the first stage and 2,716 in the second stage. Cesarean deliveries performed in the second stage were associated with longer operative times, epidural analgesia, chorioamnionitis, and higher birth weight (all P.001). The maternal composite index was slightly increased in women undergoing cesarean delivery in the second stage of labor, primarily due to uterine atony, uterine incision extension, and incidental cystotomy. This difference was significant after multivariable analysis (odds ratio 1.21, 95% confidence interval 1.07-1.37). After multivariable analysis, the neonatal composite did not differ significantly between groups (odds ratio 0.96, 95% confidence interval 0.84-1.08).Cesarean delivery in the second stage of labor is associated with slightly increased maternal but not neonatal composite morbidity.II.

To compare pregnancy outcomes in women with one prior low-transverse cesarean delivery after induction of labor with pregnancy outcomes after spontaneous labor.This study is an analysis of women with one prior low-transverse cesarean and a singleton gestation who underwent a trial of labor and who were enrolled in a 4-year prospective observational study. Pregnancy outcomes were evaluated according to whether a woman underwent spontaneous labor or labor induction.Among the 11,778 women studied, vaginal delivery was less likely after induction of labor both in women without and with a prior vaginal delivery (51% versus 65%, P.001; and 83% versus 88%, P.001). An increased risk of uterine rupture after labor induction was found only in women with no prior vaginal delivery (1.5% versus 0.8%, P=.02; and 0.6% versus 0.4%, P=.42). Blood transfusion, venous thromboembolism, and hysterectomy were also more common with induction among women without a prior vaginal delivery. No measure of perinatal morbidity was associated with labor induction. An unfavorable cervix at labor induction was not associated with any adverse outcomes except an increased risk of cesarean delivery.Induction of labor in the study population is associated with an increased risk of cesarean delivery in all women with an unfavorable cervix, a statistically significant, albeit clinically small, increase in maternal morbidity in women with no prior vaginal delivery, and no appreciable increase in perinatal morbidity.II.

Objective This study was undertaken to compare uterine contraction frequency in twins versus singletons and to determine if contraction frequency can be an efficient predictor of spontaneous preterm birth in twin gestations. Study design Fifty-nine twin and 306 singleton gestations were enrolled between 22 and 24 weeks at 11 centers. Contraction frequency was recorded with a home uterine activity monitor (HUAM) 2 or more times per day on 2 or more days per week until delivery or 36-6/7 weeks. Masked HUAM data were interpreted according to standard protocol. Repeated measures analyses were used to determine whether mean or maximum uterine contraction frequency per hour differed between singleton and twin gestations across gestational age, by time of day, and by delivery before 35 weeks or beyond. Uterine contraction frequency was also evaluated by logistic regression and receiver operator characteristic (ROC) curves as tests to predict spontaneous preterm birth. Results There were 34,908 hours of HUAM data recorded by the 306 singleton gestations and 5,427 hours by the 59 women with twins. Uterine contraction frequency was significantly greater in twins ( P = .002) compared with singletons, regardless of gestational age. Contraction frequency in twins increased significantly with gestational age and time of day (1600-0359 hours); but was not associated with spontaneous preterm birth. Maximum uterine contraction frequency was associated with preterm birth less than 35 weeks but only in the morning (am) recording (0400-1559) and at the 29- to 30-week gestational age interval. This relationship was modest (odds ratio 1-2) and not consistent across gestational age or between the am and afternoon/evening (pm) monitoring sessions. ROC analysis revealed no contraction frequency that efficiently identified twins who delivered prematurely at any 2-week gestational age interval. Conclusion Mean uterine contraction frequency was significantly higher for twin gestations than singletons throughout the latter half of pregnancy and between 1600 and 0359 hours but was not higher among twins who delivered less than 35 weeks' gestation. Neither maximum am or pm contraction frequency predicted spontaneous preterm birth less than 35 weeks' gestation in twin pregnancies.

To evaluate whether women who agree to future use of their biologic specimens for genetic studies reflect the larger study population from which they are derived.Women were questioned as to the future disposition of their maternal and fetal DNA samples upon enrollment in a multicenter, observational study originally designed to identify factor V Leiden mutation carriers and prospectively ascertain the estimated rate of pregnancy-related venous thromboembolism and adverse pregnancy outcome. Univariate and multivariate analyses was carried out on the 5,003 of 5,188 enrolled women who indicated their desire regarding future disposition of their DNA samples.Among these 5,003 women, 20.1% desired that their samples be discarded and not available for future genetic studies. Multivariate analysis demonstrated that women who agreed to subsequent use of samples were less likely African-American (odds ratio [OR] 0.6, 95% confidence interval [CI] 0.4-0.7) or Hispanic (OR 0.4, 95% CI 0.3-0.5), and more likely to use tobacco (OR 1.2, 95% CI 1.0-1.6) than those who desired that their samples be discarded.Genetic samples from women agreeing to their use in a sample repository may not be representative of the index study cohort. This should be considered in their subsequent interpretation and generalizability.III.

To describe the incidence and type of fetal injury identified in women undergoing cesarean delivery.Between January 1, 1999, and December 31, 2000, a prospective cohort study of all cesarean deliveries was conducted at 13 university centers. Information regarding maternal and infant outcomes was abstracted directly from hospital charts.A total of 37,110 cesarean deliveries were included in the registry, and 418 (1.1%) had an identified fetal injury. The most common injury was skin laceration (n = 272, 0.7%). Other injuries included cephalohematoma (n = 88), clavicular fracture (n = 11), brachial plexus (n = 9), skull fracture (n = 6), and facial nerve palsy (n = 11). Among primary cesarean deliveries, deliveries with a failed forceps or vacuum attempt had the highest rate of injuries (6.9%). In women with a prior cesarean delivery, the highest rate of injury also occurred in the unsuccessful trial of forceps or vacuum (1.7%), and the lowest rate occurred in the elective repeat cesarean group (0.5%). The type of uterine incision was associated with fetal injury, 3.4% "T" or "J" incision, 1.4% for vertical incision, and 1.1% for a low transverse (P = .003), as was a skin incision-to-delivery time of 3 minutes or less. Fetal injury did not vary in frequency with the type of skin incision, preterm delivery, maternal body mass index, or infant birth weight greater than 4,000 g.Fetal injuries complicate 1.1% of cesarean deliveries. The frequency of fetal injury at cesarean delivery varies with the indication for surgery as well as with the duration of the skin incision-to-delivery interval and the type of uterine incision.II-3.

The purpose of this study was to determine the influence of change in infant birth weight between pregnancies on the outcome of a trial of labor for women whose first cesarean delivery was performed for dystocia.Secondary analysis of 7081 patients with 1 previous cesarean delivery and no other deliveries after 20 weeks' gestation, undergoing a trial of labor with a singleton gestation. Cases were classified as dystocia if the listed indication for the cesarean delivery in the first pregnancy was failed induction, cephalo-pelvic disproportion, failure to progress, or failed forceps or vacuum. Outcomes of the trial of labor were correlated with fetal size relative to birth weight in the initial pregnancy for those women whose initial cesarean delivery was for dystocia and those with other indications.For the cohort being studied (n = 7081), dystocia was the indication for the first cesarean delivery for 3182 (44.9%). Trial of labor resulted in vaginal delivery for 54% of patients whose first cesarean delivery was performed for dystocia, compared with 67% for those with other indications (P.01). For those whose first cesarean delivery was for dystocia, trial of labor success was correlated with birth weight differences between the pregnancies, with only 38% delivering vaginally if the trial of labor birth weight exceeded the initial pregnancy birth weight by more than 500 g. Using logistic regression and adjusting for other potential confounding factors, the odds of success decreased by 3.8% for each increase of 100 g in birth weight in the trial of labor relative to the first birth weight.For women with previous cesarean delivery for dystocia, increasing birth weight in the subsequent trial of labor relative to the first birth weight diminishes the chances of successful vaginal delivery.

Objective This study was undertaken to compare success rates of vaginal birth after cesarean (VBAC) delivery, and uterine rupture as well as maternal/perinatal outcomes between women with preterm and term pregnancies undergoing trial of labor (TOL), and to compare maternal and neonatal morbidities in those women with preterm pregnancies undergoing a TOL versus repeat cesarean delivery without labor (RCD). Study design Prospective 4-year observational study of women with a singleton gestation and a prior cesarean delivery at 19 academic centers. Clinical characteristics, maternal complications and VBAC delivery success for those with a preterm (24 0 -36 6 weeks) TOL, preterm RCD and term TOL (≥37 weeks) were analyzed. Results Among 3119 preterm pregnancies with prior cesarean delivery, 2338 (75%) underwent a TOL. 15,331 women undergoing TOL at term were also analyzed as a control group. TOL success rates for preterm and term pregnancies were similar (72.8% vs 73.3%, P = .64). Rates of uterine rupture (0.34% vs 0.74%, P = .03) and dehiscence (0.26% vs 0.67%, P = .02) were lower in preterm compared with term TOL. Thromboembolic disease, coagulopathy and transfusion were more common in women undergoing a preterm TOL than those at term. Among women undergoing a preterm TOL, rates of uterine dehiscence, coagulopathy, transfusion, and endometritis were similar to those having a preterm RCD. After controlling for gestational age at delivery and race, neonatal outcomes such as Neonatal Intensive Care Unit (NICU) admission, intraventricular hemorrhage, sepsis, and ventilatory support were similar in both groups except for a higher rate of respiratory distress syndrome in those delivered after a TOL. Conclusion The likelihood of VBAC success after TOL in preterm pregnancies is comparable to term gestations, with a lower risk of uterine rupture. Perinatal outcomes are similar with preterm TOL and RCD. TOL should be considered as an option for women undergoing preterm delivery with a history of prior cesarean delivery.

To determine whether the risk for uterine rupture is increased in women attempting vaginal birth after multiple cesarean deliveries.We conducted a prospective multicenter observational study of women with prior cesarean delivery undergoing trial of labor and elective repeat operation. Maternal and perinatal outcomes were compared among women attempting vaginal birth after multiple cesarean deliveries and those with a single prior cesarean delivery. We also compared outcomes for women with multiple prior cesarean deliveries undergoing trial of labor with those electing repeat cesarean delivery.Uterine rupture occurred in 9 of 975 (0.9%) women with multiple prior cesarean compared with 115 of 16,915 (0.7%) women with a single prior operation (P = .37). Multivariable analysis confirmed that multiple prior cesarean delivery was not associated with an increased risk for uterine rupture. The rates of hysterectomy (0.6% versus 0.2%, P = .023) and transfusion (3.2% versus 1.6%, P.001) were increased in women with multiple prior cesarean deliveries compared with women with a single prior cesarean delivery attempting trial of labor. Similarly, a composite of maternal morbidity was increased in women with multiple prior cesarean deliveries undergoing trial of labor compared with those having elective repeat cesarean delivery (odds ratio 1.41, 95% confidence interval 1.02-1.93).A history of multiple cesarean deliveries is not associated with an increased rate of uterine rupture in women attempting vaginal birth compared with those with a single prior operation. Maternal morbidity is increased with trial of labor after multiple cesarean deliveries, compared with elective repeat cesarean delivery, but the absolute risk for complications is small. Vaginal birth after multiple cesarean deliveries should remain an option for eligible women.II-2.

Objective The objective of the study was to estimate whether midpregnancy genitourinary tract infection with Chlamydia trachomatis is associated with an increased risk of subsequent preterm delivery. Study design Infection with C. trachomatis was determined using a ligase chain reaction assay (performed in batch after delivery) of voided urine samples collected at the randomization visit (16 0/7 to 23 6/7 weeks' gestation) and the follow-up visit (24 0/7 to 29 6/7 weeks) among 2470 gravide women with bacterial vaginosis or Trichomonas vaginalis infection enrolled in 2 multicenter randomized antibiotic treatment trials (metronidazole versus. placebo). Results The overall prevalence of genitourinary tract C. trachomatis infection at both visits was 10%. Preterm delivery less than 37 weeks' or less than 35 weeks' gestational age was not associated with the presence or absence of C. trachomatis infection at either the randomization (less than 37 weeks: 14% versus 13%, P =.58; less than 35 weeks: 6.4% versus 5.5%, P =.55) or the follow-up visit (less than 37 weeks: 13% versus 11%, P =.33; less than 35 weeks: 4.4% versus 3.7, P =.62). Treatment with an antibiotic effective against chlamydia infection was not associated with a statistically significant difference in preterm delivery. Conclusion In this secondary analysis, midtrimester chlamydia infection was not associated with an increased risk of preterm birth. Treatment of chlamydia was not associated with a decreased frequency of preterm birth.

The purpose of this study was to evaluate the associations between measured amniotic fluid volume and outcome after preterm premature rupture of membranes (PROM).This was a secondary analysis of 290 women, with singleton pregnancies, who participated in a trial of antibiotic therapy for preterm PROM at 24(0) to 32(0) weeks. Each underwent assessment of the 4 quadrant amniotic fluid index (AFI) and a maximum vertical fluid pocket (MVP) before randomization. The impact of low AFI (5.0 cm) and low MVP (2.0 cm) on latency, amnionitis, neonatal morbidity, and composite morbidity (any of death, RDS, early sepsis, stage 2-3 necrotizing enterocolitis, and/or grade 3-4 intraventricular hemorrhage) was assessed. Logistic regression controlled for confounding factors including gestational age at randomization, GBS carriage, and antibiotic study group.Low AFI and low MVP were identified in 67.2% and 46.9% of women, respectively. Delivery occurred by 48 hours, 1 and 2 weeks in 32.4%, 63.5% and 81.7% of pregnancies, respectively. Both low AFI and low MVP were associated with shorter latency (P.001), and with a higher rate of delivery at 48 hours, 1, and 2 weeks (P = .02 for each). However, neither test offered significant additional predictive value over the risk in the total population. Low AFI and low MVP were not associated with increased amnionitis. After controlling for other factors, both low MVP and low AFI were associated with shorter latency (Por = .002), increased composite morbidity (P = .03), and increased RDS (Por = .01), but not with increased neonatal sepsis (P = .85) or pneumonia (P = .53). Alternatively, after controlling for fluid volume, gestational age, and GBS carriage, the antibiotic study group had longer latency, and suffered less common primary outcomes and neonatal sepsis.Oligohydramnios should not be a consideration in determining which women will be candidates for expectant management or antibiotic treatment when it is identified at initial assessment of preterm PROM remote from term.

The purpose of this study was to examine the utility of a single second-trimester plasma corticotropin-releasing hormone measurement as a marker for preterm delivery in women at high risk for preterm delivery.This is an analysis of data from a multicenter placebo-controlled trial designed to evaluate the role of 17 alpha hydroxyprogesterone caproate (17P) in the prevention of recurrent preterm birth. Women with a documented history of a previous spontaneous preterm birth at37 weeks were enrolled (16-20 wks) and randomly assigned in a 2 to 1 ratio to weekly injections of 17P or matching placebo. Blood was collected before treatment in 170 patients (113 assigned 17P and 57 placebo) who were enrolled at 11 of the 19 centers. Plasma levels of corticotropin-releasing hormone were compared between those who delivered preterm and those delivering at term. Data were analyzed using the Wilcoxon rank-sum test.The overall rates of preterm birth in this cohort of 170 patients were 35.9% at37 weeks (31.9% progesterone, 43.9% placebo), and 19.4% at35 weeks (18.6% vs 21.1%). The median levels of corticotropin-releasing hormone were similar between those delivering at37 weeks and those deliveringor = 37 weeks (0.39 ng/mL vs 0.37 ng/mL, P = .08). In addition, there were no differences in corticotropin-releasing hormone levels among those who delivered at35 weeks oror = 35 weeks (0.36 vs 0.38, P = .90). Moreover, there were no differences in corticotropin-releasing hormone levels among those in the placebo group who delivered at37 oror = 37 weeks (0.40 vs 0.41, P = .72) and at35 oror = 35 weeks (P = .64).A single measurement of corticotropin-releasing hormone at 16 to 20 weeks' gestation is not a good biomarker for recurrent preterm delivery in patients at high risk for this complication.

Objective To examine how demographic and pregnancy characteristics can affect the risk of recurrent preterm delivery and the how the effectiveness of progesterone treatment for prevention alters these relationships. Methods This was a secondary analysis of a randomized trial of 17alpha-hydroxyprogesterone caproate to prevent recurrent preterm delivery in women at risk. Associations of risk factors for preterm delivery (less than 37 completed weeks of gestation) were examined separately for the women in the 17alpha-hydroxyprogesterone caproate (n = 310) and placebo (n = 153) groups. Results Univariate analysis found that the number of previous preterm deliveries and whether the penultimate delivery was preterm were significant risk factors for preterm delivery in both the placebo and progesterone groups. High body mass index was protective of preterm birth in the placebo group. Multivariate analysis found progesterone treatment to cancel the risk of more than 1 previous preterm delivery, but not the risk associated with the penultimate pregnancy delivered preterm. Obesity was associated with lower risk for preterm delivery in the placebo group but not in the women treated with progesterone. Conclusion The use of 17alpha-hydroxyprogesterone caproate in women with a previous preterm delivery reduces the overall risk of preterm delivery and changes the epidemiology of risk factors for recurrent preterm delivery. In particular, these data suggest that 17alpha-hydroxyprogesterone caproate reduces the risk of a history of more than 1 preterm delivery. Level of evidence I.

Objective The purpose of this study was to define independent risk factors for uterine atony after primary cesarean delivery, and to assess their overall association with atony in the study cohort. Study design This was a 13–university center prospective observational study. All women who underwent primary cesarean from January 1, 1999 to December 31, 2000 were eligible. Trained and certified research nurses performed systematic data abstraction. The definition of atony required both the clinical diagnosis and the use of methergine or a prostaglandin preparation. Risk factors for uterine atony were assessed in univariable and multivariable logistic regression analyses, and these analyses then used to inform an assessment of the association of the various risk factors with the occurrence of uterine atony in the overall cohort. Results Twenty-three thousand, three hundred and ninety pregnancies were analyzed. Uterine atony occurred in 1416 women (6%). Several variables were independently associated with atony in a multivariable model, including multiple gestation (odds ratio [OR] 2.40, 95% CI 1.95-2.93), maternal Hispanic race (2.21, 1.90-2.57), induced or augmented labor for >18 hours (2.23, 1.92-2.60), infant birth weight >4500 g (2.05, 1.53-2.69), and clinically diagnosed chorioamnionitis (1.80, 1.55-2.09). However, because the various risk factors were not very powerful, approximately half of the cases of atony were associated with the 2/3 of women lacking a given risk factor or combination of risk factors. Conclusion Although certain risk factors and uterine atony were clearly associated, the associations are of limited practical clinical use.

To quantify anesthesia-related complications associated with cesarean delivery in a well-described, prospectively ascertained cohort from multiple university-based hospitals in the United States and to evaluate whether certain factors would identify women at increased risk for a failed regional anesthetic.A prospective observational study was conducted of women (n = 37,142) with singleton gestations undergoing cesarean delivery in the centers forming the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Detailed information was collected regarding choice of anesthesia and procedure-related complications, including failed regional anesthetic and maternal death. Potential risk factors for a failed regional anesthetic were analyzed.Of the women studied, 34,615 (93%) received a regional anesthetic. Few (3.0%) regional procedures failed, and related maternal morbidity was rare. Increased maternal size, higher preoperative risk, rapid decision-to-incision interval, and placement later in labor were all significantly related to an increased risk of a failed regional procedure. Of the general anesthetics, 38% were administered when the decision-to-incision interval was less than 15 minutes. Women deemed at the greatest preoperative risk (American Society of Anesthesiologists scoreor = 4) were approximately 7-fold more likely to receive a general anesthetic (odds ratio 6.9, 95% confidence interval 5.83-8.07). There was one maternal death, due to a failed intubation, in which the anesthetic procedure was directly implicated.Regional techniques have become the preferred method of anesthesia for cesarean delivery. Procedure-related complications are rare and attest to the safety of modern obstetric anesthesia for cesarean delivery in the United States.

The purpose of this study was to compare perinatal outcomes among women with conservatively treated preterm premature rupture of membranes at 24 to 32 weeks of gestation in the presence or absence of vaginal bleeding.This is a secondary analysis of 581 women with and without vaginal bleeding within 1 week of admission with preterm premature rupture of membranes at 24 to 32 weeks of gestation who were enrolled in a multicenter trial of antibiotic therapy during conservative treatment. The main outcome was latency to delivery. Other outcome variables included clinical abruptio placentae, amnionitis, perinatal death, severe intraventricular hemorrhage, and respiratory distress syndrome.Outcome data were available for 581 patients (n=50 with bleeding). Latency to delivery was not affected by the presence or absence of bleeding. In general, a history of bleeding was associated with higher frequencies of subsequently diagnosed abruptio placentae (12% vs 3.5%; P=.01), perinatal death (16% vs 4.9%; P=.006), intraventricular hemorrhage (14.3% vs 5.9%; P=.03), and respiratory distress syndrome (69.4% vs 40.4%; P.0001), when compared with those women with nonbleeding events. Women with bleeding were less likely to be black (42% vs 60%; P=.002) and had a lower mean gestational age at preterm premature rupture of membranes (27.6 vs 28.5 weeks; P=.02) when compared with white, Hispanic, and other. After an adjustment of data was made for potentially confounding factors, women with recent bleeding were more likely to be diagnosed with abruptio placentae at delivery (odds ratio, 2.8; 95% CI, 1.03-7.8; P=.04), and their infants were more likely to have respiratory distress syndrome (odds ratio, 3.1; 95% CI, 1.5-6.6; P=.004).Vaginal bleeding before preterm premature rupture of membranes is associated with increased rates of neonatal respiratory distress syndrome and abruptio placentae, but not with reduced latency to delivery.

It is stated commonly that the earlier in pregnancy bacterial vaginosis is diagnosed, the greater is the increase in risk of preterm birth compared with women without bacterial vaginosis. However, this contention is based on small numbers of women.In this analysis of 12,937 women who were screened for bacterial vaginosis as part of a previously conducted clinical trial, the odds ratio of preterm birth (7 weeks of gestation) for asymptomatic bacterial vaginosis-positive versus bacterial vaginosis-negative women was evaluated among women who were screened from 8 to 22 weeks of gestation.The odds ratio of preterm birth among bacterial vaginosis-positive versus bacterial vaginosis-negative women ranged from 1.1 to 1.6 and did not vary significantly according to the gestational age at which bacterial vaginosis was screened. The odds ratio for preterm birth did not vary significantly by gestational age at diagnosis when bacterial vaginosis was subdivided into Gram stain score 7 to 8 or 9 to 10.Although bacterial vaginosis was associated with an increased risk of preterm birth, the gestational age at which bacterial vaginosis was screened for and diagnosed did not influence the increase.

Fewer women today are attempting vaginal delivery after a previous cesarean delivery, mostly because of concern about its safety. This prospective cohort study, carried out at 19 academic medical centers, compared outcomes in 17,898 women with a history of cesarean section who attempted vaginal delivery and 15,801 others who had elective repeat cesarean section without labor. Women having a trial of labor were more likely than those having elective repeat cesarean delivery to be less than 30 years of age, black, unmarried, and nonobese. They also were likelier to have both preterm and delayed delivery. Vaginal delivery succeeded in 73.4% of women. The rate of symptomatic uterine rupture in women having a trial of labor was 0.7%. It was the same for those having a previous low transverse incision and 2.0% in those with a previous low vertical incision. Uterine rupture was associated with augmentation of labor using oxytocin and also with induction of labor by any method. Both endometritis and maternal blood transfusion were significantly more frequent with a trial of labor. Hysterectomy was performed in 88 women, in 41 after a trial of labor. The odds ratio for maternal adverse events in women having a trial of labor was 1.96 (95% confidence interval, 1.73-2.22) after adjusting for demographic differences and maternal diseases. Hypoxic-ischemic encephalopathy was significantly more frequent when women had a trial of labor at term than in the infants of women having elective repeat cesarean delivery. Both stillbirths and neonatal deaths were more frequent in the trial of labor group. There were no intrapartum fetal deaths. Adverse perinatal outcomes are more frequent when women with a history of cesarean delivery who undergo a trial of labor. Maternal adverse events also are increased. Although the degree of risk is small, it is important that both pregnant women and the healthcare providers who advise them be aware of the possible consequences.

Objective Preterm premature rupture of the membranes (PPROM) is believed to be caused, in part, by abnormalities of collagen and increased levels of oxidative stress. Elevated homocysteine levels have been shown to induce these same pathophysiologic changes. We tested the hypothesis that serum homocysteine levels would be higher in women with PPROM when compared with matched control women. Study design A secondary analysis derived from 2 previously completed studies performed in the National Institutes of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network. We identified 99 study cases with PPROM (24 to 32 weeks' gestation) and matched them with 99 asymptomatic control women from an observational study of preterm birth prediction. Cases and control women were matched for race, gestational age at sampling, and MFMU Network center. Serum homocysteine levels were determined by immunoassay in batch fashion by personnel masked to study arm and clinical outcomes. Serum homocysteine levels were compared between groups, as were the baseline characteristics of maternal age, cigarette smoking, nulliparity, infections during pregnancy, and body mass index (BMI) 2 . Serum homocysteine levels were dichotomized as >75th, 90th, and 95th %ile of control women, and the likelihood of elevated homocysteine levels was determined in women who smoked, had a BMI 2 , or who had PPROM. Statistical analyses included the Wilcoxon rank sum, chi-square, and Pearson correlation coefficient, where appropriate. Baseline characteristics were controlled with a logistic regression model. Results Serum homocysteine levels measured in patients with PPROM were not significantly different from matched control women: median and (25th to 75th %ile): 4.9 (3.5-6.2) vs 4.8 (3.9-6.2 μmol/L), P =.73. In our population, neither the number of cigarettes smoked ( r =−0.08, P =.57), nor BMI ( r =−0.08, P =.24) correlated with serum homocysteine levels. The strongest association was seen in women with PPROM having serum homocysteine levels >95th %ile of control women (odds ratio [OR] 2.7, P =.10). After adjusting for baseline characteristics, no correlation between serum homocysteine level and the presence of PPROM was seen, OR 1.0 (.9-1.1); P =.99. Conclusion Women presenting with PPROM did not have significantly increased serum homocysteine levels when compared with control women.

The purpose of this study was to evaluate the relationship between chorioamnionitis and its duration to adverse maternal, fetal, and neonatal outcomes.This was a 13-university center, prospective observational study. All women at term carrying a singleton gestation who underwent primary cesarean from January 1, 1999 to December 31, 2000 were eligible. Data abstraction was systematic and performed by trained research nurses. Selected adverse outcomes were compared between pregnancies with, and without, clinically diagnosed chorioamnionitis using relative risks (RRs) and 95% CIs. The duration of chorioamnionitis was stratified into 5 intervals (or=3 h,3-6 h,6-9 h,9-12 h, and12 h), and respective outcomes compared by Mantel-Haenszel test for trend. Additionally, regression analysis was used to compute odds ratios (ORs) and 95% CIs for chorioamnionitis duration length as a continuous explanatory variable.16,650 pregnancies were analyzed, 1965 (12%) with chorioamnionitis, which was associated with significantly increased risks of maternal blood transfusion, uterine atony, septic pelvic thrombophlebitis, and pelvic abscess (RR 2.3-3.7), as well as 5-minute Apgaror=3, neonatal sepsis, and seizures (RR 2.1-2.8). By test of trend, only uterine atony (P.01), maternal blood transfusion (P=.03), maternal admission to intensive care unit (P=.02), and 5-minute Apgaror=3 (P.01) were associated with duration of chorioamnionitis. By logistic analysis, only uterine atony (OR for each hour of chorioamnionitis 1.03, 95% CI 1.00-1.06), 5-minute Apgaror=3 (OR 1.09, 95% CI 1.00-1.16), and neonatal mechanical ventilation within 24 hours of birth (OR 1.07, 95% CI 1.01-1.12) were significantly associated with chorioamnionitis duration.Chorioamnionitis was associated with increased rates of morbidity after cesarean at term. The duration of chorioamnionitis, however, was not related to most measures of adverse maternal or fetal-neonatal outcome.

Background Women who have had a spontaneous preterm delivery are at greatly increased risk for preterm delivery in subsequent pregnancies. The results of several small trials have suggested that 17 alpha-hydroxyprogesterone caproate (17P) may reduce the risk of preterm delivery. Methods We conducted a double-blind, placebo-controlled trial involving pregnant women with a documented history of spontaneous preterm delivery. Women were enrolled at 19 clinical centers at 16 to 20 weeks of gestation and randomly assigned by a central data center, in a 2:1 ratio, to receive either weekly injections of 250 mg of 17P or weekly injections of an inert oil placebo; injections were continued until delivery or to 36 weeks of gestation. The primary outcome was preterm delivery before 37 weeks of gestation. Analysis was performed according to the intention-to-treat principle. Results Base-line characteristics of the 310 women in the progesterone group and the 153 women in the placebo group were similar. Treatment with 1...

The Preterm Prediction Study conducted by the Maternal Fetal Medicine Network between 1993 and 1996 studied a large number of risk factors for preterm birth in more than 3,000 women at 10 centers. The goals of the study were to better understand the strength of one risk factor versus another and to explore interactions among the predictors looking for combinations of factors that were more predictive of preterm birth than any single factor used alone. The most potent factors that were associated with spontaneous preterm birth at32 weeks were a positive cervical-vaginal fetal fibronectin test (odds ratio, 32.7) andl0th 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), and75th percentile of granulocyte colony-stimulating factor (odds ratio, 5.5). Results for spontaneous preterm birth at35 weeks were generally similar but not as strong. The overlap among the strongest biologic markers for predicting spontaneous preterm birth was small. This suggests that the use of tests such as maternal alpha-fetoprotein, alkaline phosphatase, and granulocyte colony-stimulating factor as a group or adding their results to fetal fibronectin 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.

The study was undertaken to identify early pregnancy vaginal markers predictive of subsequent preterm birth.In a multicenter Bacterial Vaginosis (BV) Trial, 21,554 women were screened with a vaginal pH and of these, two populations were studied. These included 12,041 who had a pregnancy outcome in the database and 6838 women who had a vaginal pH of 4.5 or greater and a Gram stain score and a pregnancy outcome in the database. ColorpHast Indicator Strips were used to determine the vaginal pH and the Nugent criteria were used to determine a vaginal Gram stain score of 0 to 10.Delivery at37,35, or32 weeks' gestation was similar for women with a vaginal pH of less than 4.4 or 4.7 (P not significant) but was increased in women with a pH of 5.0 (P =.04,.02,.03, respectively) or with a pH of 5.0 or greater (at each gestational age P.0001). The effect of pH of 5.0 or greater was similar for women who had a spontaneous preterm birth at each gestational age (P.0001) or birth weight of less than 2500 g or less than 1500 g (P.0005). Women with a vaginal pH of 4.5 or greater and a Gram stain score of 9 to 10 (compared with 0-8) had increased preterm births at37,35, and32 weeks' gestation (P.01), and birth weights less than 2500 g (P.0001) or less than 1500 g (P.01). Women whose vaginal pH was 5.0 or greater had a higher prevalence of vaginal fetal fibronectinor =50 ng/mL (P.0001), but the proportion of women with a vaginal fetal fibronectinor =50 mg/mL did not differ by Gram stain score.Women with a vaginal pH of 5.0 or greater or a vaginal pH of 4.5 or greater and a Gram stain score of 9 to 10 had significantly increased preterm births at37,35, and 32 weeks' gestation and/or a birth weight less than 2500 g or less than 1500 g.

OBJECTIVE: To estimate the rate of congenital varicella zoster virus syndrome in neonates born to women developing varicella zoster virus infections during pregnancy. METHODS: Pregnant women with clinical varicella zoster virus infection were enrolled at ten perinatal centers. Maternal and fetal immunoglobulin (Ig) G and IgM by fluorescent antibody confirmed 74.3% of cases. Specialists examined neonates at 0–6 months, 7–18 months, and 19–30 months after delivery to detect abnormalities of their eyes, hearing, and physical and developmental features. A hierarchical set of criteria was used to define congenital varicella syndrome. A jury of four investigators assigned the classification of all findings. RESULTS: In 362 women enrolled from 1993 to 1996, 15 had herpes zoster, and 347 had primary varicella zoster virus infection. Varicella zoster virus affected 140 women (38.7%) in the first trimester, 122 (33.7%) in the second trimester, and 100 (27.6%) in the third trimester. Five twin pairs were included. Only one case (0.4%) of definite congenital varicella syndrome was found, a 3360-g female infant having a left retinal macular lesion with typical skin scars after maternal varicella at 24 weeks. The maternal blood sample at birth was negative for IgG antibodies to toxoplasmosis and cytomegalovirus. Two cases involved fetal death at 20 weeks and fetal hydrops at 17 weeks after maternal varicella at 11 and 5 weeks, respectively. We found no cases of limb hypoplasia, microcephalus, or cataract. CONCLUSION: The frequency of congenital varicella syndrome is very low (0.4%) in a prospectively studied cohort. Eye examinations of exposed infants had a low yield.

High levels of a number of analytes are found in maternal blood; alkaline phosphatase,alpha-fetoprotein, and corticotropin-releasing hormone have been associated with spontaneous preterm birth. We investigated the relationship between 8 potential blood markers and subsequent spontaneous preterm birth in asymptomatic pregnant women.We performed a nested case control study that involved 127 women who were enrolled in the preterm prediction study and who had a singleton spontaneous preterm birth at35 weeks and 127 women who had a term birth and served as matched (age, parity, center) controls. Serum that was collected at 24 and 28 weeks was analyzed for alkaline phosphatase, alpha-fetoprotein, corticotropin-releasing hormone, and 5 other analytes.Alkaline phosphatase, alpha-fetoprotein, and corticotropin-releasing hormone, but not other analytes, were significantly elevated in pregnancies that ended in spontaneous preterm birth. For alkaline phosphatase at 24 weeks, the odds ratio for spontaneous preterm birth at32 weeks was 6.8 (range, 1.4-32.8) and for spontaneous preterm birth at35 weeks 5.1 (range, 1.7-15.6). Similar results were found at 28 weeks. For alpha-fetoprotein at 24 weeks, the odds ratio for spontaneous preterm birth at32 weeks was 8.3 (range,2.2-30.9) and for spontaneous preterm birth at35 weeks was 3.5 (range, 1.8-6.7). The levels at 28 weeks were still predictive but less so than at 24 weeks. Corticotropin-releasing hormone, at 28 weeks but not at 24 weeks, was predictive for spontaneous preterm birth at35 weeks, with an odds ratio 3.4 (range, 1.0-10.9).Elevated alkaline phosphatase and alpha-fetoprotein are associated with subsequent spontaneous preterm birth in asymptomatic pregnant women at 24 and 28 weeks. Elevated corticotropin-releasing hormone levels at 28 weeks are associated with spontaneous preterm birth at35 weeks.

OBJECTIVE: Low serum ferritin levels correlate with low iron stores, whereas high levels are associated with an acute-phase reaction. Our objective was to determine whether elevated levels of ferritin in the genital tract may be a potent marker to identify patients at risk for spontaneous preterm delivery. STUDY DESIGN: We performed a nested case-control study involving 182 women who had spontaneous preterm delivery and 182 term control subjects matched for race, parity, and recruitment center, and selected from 2929 women enrolled in the Preterm Prediction Study of the National Institute of Child Health and Development Maternal-Fetal Medicine Units Network. Cervical fluid ferritin was measured by use of radioimmunoassay. RESULTS: Cervical ferritin levels were significantly higher in women who subsequently had spontaneous early preterm delivery ( P =.002; and P =.004) than in term controls. A cervical ferritin of >75th percentile in the controls (>35.5 ng/mL) was found in 52.9% (9/17) of the women delivered CONCLUSIONS: Elevated cervical ferritin levels at 22 to 24 weeks of gestation in asymptomatic women are associated with subsequent spontaneous preterm birth. The strong correlation of cervical ferritin with other inflammatory markers provides support for the hypothesis of infection as a mediator of preterm delivery. (Am J Obstet Gynecol 2002;186:458-63.)

To determine the factors associated with an increased risk of developing varicella-zoster virus (VZV) pneumonia during pregnancy, a case-control analysis was done in which 18 pregnant women with VZV pneumonia were compared with 72 matched control subjects. VZV infection was identified clinically, and VZV pneumonia was diagnosed by dyspnea and findings on chest radiographs. Of 347 pregnant women with VZV infection, 18 (5.2%) had pneumonia treated with acyclovir, and none died. Mean gestational age at rash onset was 25.8 plus minus 8.8 weeks for patients with pneumonia and 17.7 +/- 10.3 weeks for control subjects, which was not significant in the multivariable model. Women with VZV pneumonia were significantly more likely to be current smokers (odds ratio [OR], 5.1; 95% confidence interval [CI], 1.6-16.7) and to have > or = 100 skin lesions (OR, 15.9; 95% CI, 1.9-130.2). Pregnant women with VZV infection may be more likely to develop varicella pneumonia if they are smokers or manifest > or = 100 skin lesions.

The measurement of the frequency of uterine contractions has not been useful for reducing the rate of preterm delivery in randomized trials. Nonetheless, ambulatory monitoring of contractions continues to be used in clinical practice.We assessed the frequency of uterine contractions as a predictor of the risk of spontaneous preterm delivery before 35 weeks of gestation. We enrolled women with singleton pregnancies between 22 and 24 weeks of gestation. The women used a contraction monitor at home to record contraction frequency twice daily on 2 or more days per week from enrollment to delivery or 37 weeks of gestation.We obtained 34,908 hours of successful monitoring recordings from 306 women. Although more contractions were recorded from women who delivered before 35 weeks than from women who delivered at 35 weeks or later, we could identify no threshold frequency that effectively identified women who delivered preterm infants. The sensitivity and positive predictive value of a maximal hourly frequency of contractions of four or more between 4 p.m. and 3:59 a.m. were 9 percent and 25 percent, respectively, at 22 to 24 weeks and 28 percent and 23 percent at 27 to 28 weeks. Other proposed screening tests, such as digital and ultrasound evaluations of the cervix and assays for fetal fibronectin in cervicovaginal secretions, also had low sensitivity and positive predictive value for preterm labor.Although the likelihood of preterm delivery increases with an increased frequency of uterine contractions, measurement of this frequency is not clinically useful for predicting preterm delivery.

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 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 Results: In the univariate analysis, the most potent markers that are associated with spontaneous preterm birth at 90th percentiles of α-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 P Conclusion: Overlap among the strongest biologic markers for spontaneous preterm birth is small. This suggests that the use of tests such as maternal serum α-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. (Am J Obstet Gynecol 2001;185:643-51.)

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.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.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).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.