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Morphologic parameters of early cleavage-stage embryos that correlate with fetal development and delivery: prospective and applied data for increased pregnancy rates.

BACKGROUND: Many different embryo selection criteria have been used in assisted reproductive technologies (ART), but there are no published prospective studies to ascertain their usefulness in predicting implantation. METHODS: In a prospective trial, 20 early scoring parameters previously reported to influence clinical outcome were collected, but embryos were selected for transfer by current laboratory protocols; day 1 pronuclear (PN) (Z) score combined with day 3 or 5 morphology. Data points for each oocyte/embryo were scored independently and tracked individually. Data were analysed retrospectively for parameters most likely to result in a positive pregnancy test, fetal heartbeat (FHB) and delivery. RESULTS: Results indicated that day 1 PN morphology and nucleolar precursor body (NPB) ratio, day 2 cell number, blastomere symmetry and nucleation and the ability to cleave from day 2 to day 3 were the six most significant factors in fetal development. This outcome was then applied prospectively over 8 months. The implantation rate (IR) and clinical pregnancy rate (CPR) increased in each age group, and the number of embryos used decreased. CONCLUSION: In conclusion, early parameters that include PN morphology, number and ratio of NPBs per nucleus and the day 2 morphology of cleaving embryos are stronger positive predictors of implantation than day 3 morphology or the ability to achieve the blastocyst stage of development. Parameters that were most consistently correlated with no delivery were lack of PN symmetry, day 2 multinucleation and uneven cell size. Day 3 and day 5 parameters were not significant compared with the combination of early parameters.

Adult↗

Versatile high-performance liquid chromatographic computer system for solvent delivery, gradient control and data acquisition using the Commodore 64 personal computer.

An interface for a high-performance liquid chromatographic system based on the Commodore 64 personal computer has been designed as an alternative to the expensive and somewhat inflexible solvent programmers and data acquisition systems offered by commercial manufacturers. The system consists of the Commodore 64 with a single disk drive and monitor, and an interface that directly controls the flow-rates of two Waters pumps for solvent delivery in either isocratic or gradient mode, as well as analog-to-digital conversion of chromatographic data and either graphic data output to a dot-matrix printer or digital-to-analog conversion for output to a chart recorder. The interface permits computer-controlled flow-rates of up to 10.0 ml/min, with an accuracy of 0.0047 ml/min at flow-rates of 4.1 ml/min and an accuracy of 0.03 ml/min at flow-rates of 10 ml/min. The software for data analysis permits tabulation of elution times and areas for the peaks in a chromatogram with an option for baseline correction. The data are stored on floppy disks together with information pertinent to the chromatogram (flow-rate, solvent composition, etc.).

Chromatography, High Pressure Liquid↗

Effect of epidural vs parenteral opioid analgesia on the progress of labor: a meta-analysis.

CONTEXT: Epidural labor analgesia, if selected by the patient, is associated with high cesarean delivery rates. Results of randomized trials comparing rates of cesarean delivery using epidural anesthesia vs parenteral opioids are inconsistent. OBJECTIVE: To review the effects of epidural vs parenteral opioid analgesia on cesarean delivery rates. DATA SOURCES: Studies were identified by searching MEDLINE from January 1966 through January 1998, the Cochrane Database of Perinatal Trials, and relevant nonindexed journals and abstracts. STUDY SELECTION: We included all studies that randomized patients to epidural vs parenteral opioid labor analgesia. DATA EXTRACTION: Two authors independently extracted data from 10 trials enrolling 2369 patients. Odds ratios (ORs) for categorical data, weighted mean differences (WMDs) for continuous data, and 95% confidence intervals (CIs) were calculated using a random-effects model. DATA SYNTHESIS: The risk of cesarean delivery did not differ between patients receiving epidural (8.2%) vs parenteral opioid (5.6%) analgesia (OR, 1.5; 95% CI, 0.81-2.76). Epidural patients had longer first (WMD, 42 minutes; 95% CI, 17-68 minutes) and second (WMD, 14 minutes; 95% CI, 5-23 minutes) labor stages. While epidural patients were more likely to have instrumented delivery (OR, 2.19; 95% CI, 1.32-7.78), they were no more likely to have instrumented delivery for dystocia (OR, 0.68; 95% CI, 0.31-1.49). After epidural analgesia, neonates were less likely to have low 5-minute Apgar scores (OR, 0.38; 95% CI, 0.18-0.81) or to need naloxone (OR, 0.24; 95% CI, 0.07-0.77). Women receiving epidural analgesia had lower pain scores during the first (WMD, -40 mm on a 100-mm scale; 95% CI, -42 to -38 mm) and second (WMD, -29 mm; 95% CI, -38 to -21 mm) stages of labor. The odds of dissatisfaction were lower with epidural analgesia (OR, 0.25; 95% CI, 0.20-0.32). CONCLUSIONS: Epidural labor analgesia is not associated with increased rates of instrumented vaginal delivery for dystocia or cesarean delivery. Patients receiving epidural analgesia have longer labors. Patient satisfaction and neonatal outcome are better after epidural than parenteral opioid analgesia.

Analgesics, Opioid↗

Effects of intramyocardial pVEGF165 delivery on regional myocardial blood flow: evidence for a spatial 'delivery-efficacy' mismatch.

The aim of this study was to determine the effects of direct intramyocardial pVEGF165 gene transfer on regional myocardial blood flow in a porcine model of chronic myocardial ischaemia. Pigs underwent placement of an ameroid constrictor around the left circumflex coronary artery. After 3 weeks, animals received direct intramyocardial injections of pVEGF165 (20 x 50 microl at 1 microg/microl, n=11) or a plasmid vector encoding chloramphenicol acetyltransferase (20 x 50 microl at 1 microg/microl, n=11) into a specified target area (TA) of the left lateral wall. At 3 weeks after gene transfer, animals underwent final evaluation including a systematic assessment of regional myocardial blood flow (MBF) under resting and stress conditions. In all, 20 animals (10 per group) reached final studies. There was no change in mean arterial blood pressure or Rentrop collateral score from gene delivery to final studies in either group, nor were there differences between study groups. MBF was significantly higher in the areas adjacent to the TA in the VEGF group under resting (P<0.001) and stress conditions (P<0.05). In addition, pVEGF165 gene transfer abolished flow differences between the adjacent areas and the septum. MBF was not different between study groups in the TA, the anterior wall, or the septum. In conclusion, direct intramyocardial pVEGF165 gene transfer significantly improves myocardial blood flow. However, this effect is limited to the myocardial segments adjacent to the area of gene delivery. These data, therefore, demonstrate a spatial 'delivery-efficacy' mismatch with implications for myocardial gene delivery sites and detection of treatment effects in vivo.

Animals↗

Outcomes of term vaginal breech delivery.

In December 2001, the American College of Obstetricians and Gynecologists revised their recommendations for breech delivery. These recommendations acknowledge that although a planned vaginal delivery may no longer be appropriate, there are instances in which vaginal breech delivery is inevitable. Moreover, there continues to be patients who for any number of reasons will choose vaginal over cesarean delivery when faced with a fetus in the breech presentation. We sought to review maternal and fetal outcomes in such circumstances when vaginal breech delivery occurs, and compare these outcomes to elective cesarean deliveries for breech presentation. We performed a retrospective review of all singleton breech deliveries at our county hospital from January 2002 through June 2003. We reviewed maternal age, ethnicity, gestational age, gravity, parity, birthweight, mode of delivery, Apgar scores, umbilical arterial blood gases, and maternal and infant complications of both cesarean deliveries and vaginal breech deliveries. Univariate and logistic regression statistical analyses were performed with NCSS software. We had a total of 150 term breech deliveries with gestational ages between 37 and 42 weeks. Of these, 41 were vaginal breech and 109 were cesarean deliveries. Greater than 95% of patients are of Hispanic origin. There were no statistically significant differences in maternal age, ethnicity, gravity, or gestational age. Mean birthweight was significantly lower and parity was significantly higher in the vaginal delivery group. There was also a higher proportion of patients who underwent labor induction/augmentation in the vaginal group. We found no differences in the outcomes of 5-minute Apgar scores, umbilical arterial blood gas values, neonatal intensive care unit admissions, deaths or maternal/fetal complications reported between the two groups. Mean umbilical arterial blood gas values were greater than 7.18 in both groups. Vaginal breech delivery cannot always be avoided. Moreover, at our county hospital several patients continue to choose vaginal breech delivery. Our data would suggest that vaginal breech delivery remains a viable option in selected patients.

Apgar Score↗

A classification of delivery patient groups using CART (Classification and Regression Trees) for an improvement of critical path.

Critical Path is able to offer high quality standardized medical treatment. In searching for the better Critical Path (CP) and improving CP, it is necessary to use it continuously. This paper indicates the improvement from two classes of delivery patient groups to five, using data mining method. The data used for analysis is medicine data based on the actual data of delivery patient groups. As a result, it became possible to offer higher quality medical treatment.

Critical Pathways↗

Maternal occupation and delivery outcome: a study using central registry data.

The outcome of all deliveries in Sweden in 1981 has been studied. The occupation of each mother was obtained by record linkage using census data from November 1980. Rates of perinatal deaths or congenital malformations did not vary according to maternal occupation, more than might be expected to happen by chance, which indicated that maternal occupation is not a major factor in the outcome of these deliveries. There was variation in the rates of low birth weight infants, according to maternal occupation, which may have been an effect of socioeconomic factors associated with the occupation. Within occupational groups, working situations may exist which entail an increased teratogenic risk, but in order to reveal such risks, studies with a different design must be carried out.

Congenital Abnormalities↗

Topiramate kinetics during delivery, lactation, and in the neonate: preliminary observations.

PURPOSE: To study the pharmacokinetics of topiramate (TPM) during delivery, lactation, and in the neonate. METHODS: TPM concentrations in plasma and breast milk were measured with fluorescence polarization immunoassay (FPIA) in five women with epilepsy treated with TPM during pregnancy and lactation. Blood samples were obtained at delivery from mothers, from the umbilical cord, and from the newborns on three occasions (24, 48, and 72 h) after delivery. Blood and breast milk also were collected from mothers 2 weeks, and 1 and 3 months postpartum. Blood samples also were drawn from the infants during breast-feeding. Three of the mother-infant pairs were studied both at delivery and during lactation; two contributed with data from delivery only. RESULTS: The umbilical cord plasma/maternal plasma ratios were close to unity, suggesting extensive transplacental transfer of TPM. The mean milk/maternal plasma concentration ratio was 0.86 (range, 0.67-1.1) at 2-3 weeks after delivery. The milk/maternal plasma concentration ratios at sampling 1 and 3 months after delivery were similar (0.86 and 0.69, respectively). Two to 3 weeks after delivery, two of the breast-fed infants had detectable (>0.9 microM) concentrations of TPM, although below the limit of quantification (2.8 microM), and one had an undetectable concentration. CONCLUSIONS: Our limited data suggest free passage of TPM over the placenta and an extensive transfer into breast milk. Breast-fed infants had very low TPM concentrations, and no adverse effects were observed in the infants.

Anticonvulsants↗

Managing the measurement: a model of data support in an integrated delivery system.

There are many functions in an integrated delivery system charged with focused, clinical excellence and process improvement based on data. Information system complexity, enhanced technology and software, and increased demand for data have created the need for one healthcare organization to look at an alternative system for data support of these key functions. This article describes a clinical data department model that has been implemented successfully in an integrated delivery system. It describes the structure and function of this department and its relationship in supporting the areas where clinical data is needed.

Data Collection↗

Risk factors for primary postpartum haemorrhage. A case control study.

The objective of the study was to determine which background factors predispose women to primary postpartum haemorrhage (PPH) at the Obafemi Awolowo University Hospital. The study consisted of 101 women who developed PPH after a normal vaginal delivery and 107 women with normal unassisted vaginal delivery without PPH Both cases and controls were investigated for sociodemographic risk factors, medical and obstetric histories, antenatal events and labour and delivery outcomes. Data were abstracted from the medical and delivery records and risks were estimated by multivariate logistic regression. The results of the univariate analysis revealed a number of potential risk factors for PPH but after adjustment by logistic regression three factors remained significant. These were prolonged second and third stages of labour and non-use of oxytocics after vaginal delivery. Previously hypothesised risk factors for PPH such as grand multiparity, primigravidity and previous episodes of PPH were not significantly associated with PPH. We conclude that primary PPH in this population is mostly associated with prolonged second and third stages of labour and non use of oxytocics. Efforts to reduce the incidence of PPH should not only be directed at proper management of labour but also training and retraining of primary health care workers and alternative health care providers in the early referral of patients with prolonged labour.

Adult↗

[Fathers' childbirth experience and nursing interventions].

The purpose of the study was to describe the childbirth experience of fathers and nursing interventions used during labour and delivery. The data were collected by questionnaires from fathers attending delivery room during one month (n = 137). Five fathers refused to participate. The return rate was 81% out of 132 fathers. Data analysis included cross tabulations, factor analysis as well as content analysis for open ended questions. Nursing interventions which fathers found supportive were infant care, getting information and attention from the staff. Most of the respondents felt they got encouragement to take care of the infant. They also got information of the delivery and newborn's welfare. However, about half felt they got little encouragement to show their own feelings. Fathers found that being present at the delivery was an important part of their fatherhood. The best moments were attached to enjoyment of taking care of the newborn. Fathers felt themselves unable to help their partner enough. They felt very difficult to see their partner in pain. Most of the father were quite satisfied with nursing interventions used during labour. They wanted more attention to be paid to pain management. Fathers would like to get more advice during labour.

Adult↗

Setting bioequivalence requirements for drug development based on preclinical data: optimizing oral drug delivery systems.

The recently proposed Biopharmaceutics Classification System can be used to classify drugs and set standards for scale-up and post-approval changes as well as standards for in vitro/in vivo correlation for immediate and controlled release products. This classification scheme is based on determining the underlying process that is controlling the drug absorption rate and extent, namely, drug solubility and intestinal membrane permeability. Theoretical analysis and experimental results suggest that a permeability/solubility classification scheme can be used to set more rationale drug standards. In particular, high solubility/high permeability, rapidly dissolving drugs may be regulated on the basis of a single point rapid dissolution test while low solubility dissolution rate limited drugs can be regulated based on an in vitro dissolution test that reflects the in vivo dissolution process. This dissolution test may include multiple time points, media change, as well as surfactants in order to reflect the in vivo dissolution process and would be used by the manufacturer for requesting a waiver from a bioequivalence (BE) trial. For controlled release products, the regulation of bioequivalence standards is more complex due to the potential differences in position-dependent permeability/solubility and metabolism of drugs along the gastrointestinal tract. These differences may result in drug absorption rates that are highly transit time dependent. This paper will present the current status of the biopharmaceutic drug classification scheme, the underlying developed data base and its application to optimizing IR and CR products.

Administration, Oral↗

Data utilization and analytical skills among mid-level health programme managers in a developing country.

Mid-level health managers in a developing country were studied to examine the extent to which they are able to use and analyse data they receive from a new health information system. Among 168 managers filling out a self-administered questionnaire, 52% could compute a simple cost-effectiveness ratio and 27% were able to calculate proportions. Only 43% of the managers were able to construct a cumulative graph similar to the one recommended by WHO. Facility with these tasks was not related to levels of training or age. Twelve out of 25 programme managers interviewed in depth did not know how well their particular programme had performed in the previous year. Similarly, only six of these managers knew their best and poorest performing districts. The results of this study suggest; 1) Training managers in data analysis and use is critical if health information systems are to actually improve health care delivery. 2) Data intended for the use of programme managers need to be presented in simple ways. 3) Further social research is required to understand how managers perceive and use data. 4) Efforts to ensure the use of data should not be seen as something to be 'added on' after information systems are in place.

Data Interpretation, Statistical↗