Maternal anthropometric risk factors for caesarean delivery before or after onset of labour.

OBJECTIVE: To quantify the effects of pre-pregnancy body mass and gestational weight gain, above and beyond their known effects on birthweight, on the risk of primary and repeat caesarean delivery performed before or after the onset of labour. DESIGN: Hospital-based historical cohort study. SETTING: Canadian university-affiliated hospital. POPULATION: A total of 63 390 singleton term (> or = 37 weeks gestation) infants with cephalic presentation. METHODS: We studied prospectively archived deliveries at the Royal Victoria Hospital in Montreal, Canada, from 1 January 1978 to 31 March 2001 using multiple logistic regression models to estimate relative odds of caesarean delivery. MAIN OUTCOME MEASURE: Caesarean delivery, primary or repeat and before or after the onset of labour. RESULTS: Pregravid obesity (body mass index > or = 30 kg/m2) increased the likelihood of primary caesarean delivery before (OR = 2.01, 95% CI 1.39-2.90) and after (OR = 2.12, 95% CI 1.86-2.42) the onset of labour. High net rate of gestational weight gain (> 0.50 kg/week) increased the risk but only after labour onset (OR = 1.40, 95% CI 1.23-1.60). Among women with a previous caesarean, high weight gain modestly increased risk but only before labour (OR = 1.38, 95% CI 1.04-1.83), whereas obesity increased the risk of caesarean delivery both before (OR = 1.85, 95% CI 1.44-2.37) and after (OR = 1.96, 95% CI 1.11-3.47) labour onset. Increased risks of macrosomia accounted for the association between pregravid adiposity and repeat caesarean delivery performed after but not before the onset of labour. CONCLUSIONS: Pregravid obesity increases the risk of caesarean delivery both before and after the onset of labour and both with and without a history of caesarean.

Outcome of neonates less than 30 weeks gestation with histologic chorioamnionitis.

The purpose of this study was to determine the short-term outcome of newborns less than 30 weeks gestation when there is definite placental histologic chorioamnionitis. A retrospective analysis was performed of records of all neonates delivered at our institution from January 1989 through January 1999. This information was retrieved from our perinatal database and pathology database. The population was stratified according to the presence or absence of histologic chorioamnionitis. Statistical analysis was performed using student t-test and Mann-Whitney method. Logistic regression was used to control for potential confounding variables. There were 392 neonates less than 30 weeks gestation delivered during this time period. Complete placental histology was available for 342 patients (87.4%). Histologic chorioamnionitis was identified in 140 (40.9%) cases. Those with histologic chorioamnionitis delivered sooner (26.3 versus 27.5 weeks), were of lower birth weight (920.1 versus 1029.8 g), and had lower 5-minute Apgarscores. Neonatal septicaemia and pneumonia were strongly associated with underlying histologic chorioamnionitis. There was a significant reduction in the incidence of respiratory distress syndrome (RDS) when histologic chorioamnionitis was present. Severe histologic chorioamnionitis increases the risk of premature delivery and is strongly associated with neonatal sepsis. There is a significant reduction in the incidence of RDS and neonatal mortality.

Obstetric implications of low-lying placentas diagnosed in the second trimester.

OBJECTIVES: To determine the obstetrical outcome of pregnancies initially complicated by a low-lying placenta in the second trimester. METHODS: We reviewed the obstetric outcome of all women with singleton deliveries from 1 January 1997 to 31 March 1999 and compared the 703 women with low-lying placentas (placentas in the lower uterine segment) with the 6938 women with placentas that were normally situated in the upper uterine segment at 16-22 weeks' gestation. RESULTS: Pregnancies complicated by a low-lying placenta in the second trimester were not associated with antepartum hemorrhage, preterm births, preterm prelabor rupture of membranes, pregnancy-induced hypertension, fetal growth restriction or cesarean births. However, they had a higher incidence of postpartum hemorrhage (odds ratio 1.768, 95% confidence interval 1.137, 2.748) than women with a normally situated placenta in the second trimester. CONCLUSIONS: Pregnant women with low-lying placentas in the second trimester have a higher incidence of postpartum hemorrhage and hence, it would be prudent to carefully manage the third stage of labor in these women.

Determinants of unexplained antepartum fetal deaths.

OBJECTIVE: To assess fetal, maternal, and pregnancy-related determinants of unexplained antepartum fetal death. METHODS: We conducted a hospital-based cohort study of 84,294 births weighing 500 g or more from 1961-1974 and 1978-1996. Unexplained fetal deaths were defined as fetal deaths occurring before labor without evidence of significant fetal, maternal, or placental pathology. RESULTS: One hundred ninety-six unexplained antepartum fetal deaths accounted for 27.2% of 721 total fetal deaths. Two thirds of the unexplained fetal deaths occurred after 35 weeks' gestation. The following factors were independently associated with unexplained fetal death: maternal prepregnancy weight greater than 68 kg (adjusted odds ratio [OR] 2.9; 95% confidence interval [CI] 1.85, 4.68), birth weight ratio (defined as ratio of birth weight to mean weight for gestational age) between 0.75 and 0.85 (OR 2.77; 95% CI 1.48, 5.18) or over 1.15 (OR 2.36; 95% CI 1.26, 4.44), fewer than four antenatal visits in women whose fetuses died at 37 weeks or later (OR 2.21; 95% CI 1.08, 4.52), primiparity (OR 1.74; 95% CI 1.26, 2.40), parity of three or more (OR 2.01; 95% CI 1.26, 3.20), low socioeconomic status (OR 1.59; 95% CI 1.14, 2.22), cord loops (OR 1.75; 95% CI 1.04, 2.97) and, for the 1978-1996 period only, maternal age 40 years or more (OR 3.69; 95% CI 1.28, 10.58). Trimester of first antenatal visit, low maternal weight, postdate pregnancy, fetal-to-placental weight ratio, fetal sex, previous fetal death, previous abortion, cigarette smoking, and alcohol use were not significantly associated with unexplained fetal death. CONCLUSION: In this study, we identified several factors associated with an increased risk of unexplained fetal death.

Knobloch syndrome involving midline scalp defect of the frontal region.

We report on a 4-year-old boy with Knobloch syndrome. He has vitreoretinal degeneration, high myopia, cataract, telecanthus, hypertelorism, and a high-arched palate. He also has a defect of the anterior midline scalp with involvement of the frontal bone as documented by a computed tomography (CT) scan. The brain was normal on CT scan and magnetic resonance imaging. We present a review of the 23 published cases with this syndrome. Our patient illustrates the importance of investigating for underlying ocular and central nervous system pathology whenever midline scalp defects are present.

Are all growth-restricted newborns created equal(ly)?

BACKGROUND: Previous etiologic studies have defined intrauterine growth restriction (IUGR) based on a single cutoff. OBJECTIVE: To assess the relative importance of known etiologic determinants for different degrees (mild versus severe) and timing (preterm versus term) of fetal growth restriction. DESIGN: Hospital-based cohort study. SETTING: Tertiary-care university hospital. PARTICIPANTS: Sixty-five thousand two hundred eighty inborn singleton infants without major congenital anomalies delivered between January 1, 1978 and March 31, 1996. MEASUREMENTS: Comparison of adjusted odds ratios (ORs) and 95% confidence intervals for mild IUGR (defined as birth weight 75% to <85% of the mean for gestational age, the latter cutoff equivalent to the 9.9th percentile for this cohort) and severe IUGR (<75% of mean, or 2.3rd percentile), after controlling for maternal age, education, marital status, and other potential determinants by means of multiple logistic regression. RESULTS: Maternal prepregnancy overweight (body mass index [BMI] >26.0-29.0 kg/m2) and obesity (BMI >29.0 kg/m2) had stronger protective effects against mild IUGR than against severe IUGR, but most of the determinants showed the opposite pattern. This was especially true for pathologic determinants; ORs (and 95% confidence intervals) for severe versus mild IUGR were 18.5 (14.5-23.8) vs 4.6 (3.6-5.8) for severe pregnancy-induced hypertension (PIH), 3.5 (2.2-5.5) vs 2.3 (1. 5-3.4) for prepregnancy hypertension, and 3.4 (2.9-3.9) vs 2.2 (2. 0-2.4) for smoking >/=11 cigarettes/day. Primiparity, short stature, prepregnancy BMI, maternal weight gain, and cigarette smoking had significantly larger effects on term IUGR, whereas the effect of severe PIH was more than twice as large for preterm IUGR (OR = 9.7 [7.3-13.0]) as for term IUGR (OR = 4.0 [3.0-5.3]). CONCLUSION: Pathologic determinants of IUGR such as prepregnancy and PIH and cigarette smoking predispose to more severe fetal growth retardation, and PIH in particular seems to do so before 37 weeks. Growth-restricted newborns are not, therefore, all created equal(ly).

Secular trends in preterm birth: a hospital-based cohort study.

CONTEXT: Canada and the United States have reported a recent increase in the incidence of preterm birth, but the reasons for this increase are unknown. OBJECTIVE: To assess secular trends in preterm birth and its potential determinants. DESIGN: Hospital-based cohort study. SETTING: Canadian tertiary care university teaching hospital, 1978-1996. PARTICIPANTS: A total of 65574 nonreferred live births and stillbirths. MAIN OUTCOME MEASURES: Changes in occurrence of preterm birth, before and after adjustment for changes in method of gestational age assessment, obstetric intervention, registration of births weighing less than 500 g, and sociodemographic, behavioral, and clinical determinants. RESULTS: A crude secular increase in preterm births was seen for births less than 37, 34, and 32 completed weeks using 3 alternative gestational age estimation methods. Based on an algorithm incorporating both menstrual and early ultrasound gestational age estimates, rates increased from 6.6% to 9.8% for births at less than 37 weeks' gestation, 1.7% to 2.3% at less than 34 weeks, and 1.0% to 1.2% at less than 32 weeks. Exclusion of births weighing less than 500 g and those with induction or preterm cesarean delivery without labor before each of the corresponding gestational age cutoffs eliminated the secular trends for births before 34 and 32 weeks and attenuated the trend for births before 37 weeks. Nearly half of the remaining trend for births before 37 weeks was accounted for by the increasing use of early ultrasound dating. The residual trend was eliminated after controlling for secular increases in unmarried status and the proportion of women aged 35 years or older. These factors, combined with a decrease in alcohol consumption and increases in histological chorioamnionitis and cocaine use, appear to have counteracted a reduction in preterm birth since the mid-1980s that otherwise would have been observed. CONCLUSIONS: This hospital's increase in preterm births since 1978 parallels increases reported in population-based national studies from the United States and Canada. This trend appears largely attributable to the increasing use of early ultrasound dating, preterm induction and preterm cesarean delivery without labor, and changes in sociodemographic and behavioral factors.

How small is too small in a twin pregnancy?

OBJECTIVE: The objective was to determine whether small twins had a survival advantage with respect to small singletons after controlling for other factors associated with adverse perinatal outcome. STUDY DESIGN: A hospital-based cohort study included all births between 1980 and 1995 of babies born between 24 and 43 weeks' gestation. Logistic regression was used to estimate the perinatal mortality risks for monochorionic and dichorionic twins with growth restriction after adjusting for gestational age, maternal age, parity, method of delivery, and the presence or absence of congenital malformations. RESULTS: The study sample included 1062 dichorionic twins, 354 monochorionic twins, and 59,873 singletons. Small monochorionic and dichorionic twins showed a similar overall risk of perinatal mortality (odds ratio 1.40, confidence interval 0.86 to 2.25). However, monochorionic twins with birth weights <10th percentile faced an increased risk of perinatal death compared with singletons (odds ratio 2.45, confidence interval 1.20 to 5.02). Dichorionic twins had no such increased risk (odds ratio 0.91, confidence interval 0.45 to 1.84). CONCLUSIONS: Twins with growth restriction are not protected against perinatal loss, even after adjusting for congenital malformations. In fact, monochorionic twins are more than twice as likely to die in the perinatal period as are their singleton counterparts.

Dexamethasone for pulmonary interstitial emphysema in preterm infants.

The efficacy of a 3-day course of dexamethasone (0.5 mg/kg/ day) in 10 preterm infants (< or = 30 weeks gestation) with pulmonary interstitial emphysema (PIE) was studied in a retrospective case review. PIE was diagnosed at a median age of 7.5 days and treatment with dexamethasone began at 8.5 days. Seven of the 10 subjects had at least 2 days of conservative treatment (lowered mean airway pressure) preceding dexamethasone during which the mean airway pressure (MAP), oxygenation index (OI) and mechanical ventilation index (MVI) were not significantly different although within 3 days of dexamethasone each variable improved significantly (p < 0.05). Similarly, for all 10 infants, OI and MAP were significantly lower at 3 and 7 days from baseline (p < 0.005). By day 7, FiO2 (p = 0.022) and MVI (p = 0.011) were significantly lower and PIE had resolved on chest X-ray in 7/9 (78%) and improved in the remaining 2/9 (22%). Nine of the 10 infants survived to term. Three days of dexamethasone was associated with significant clinical improvement in most of these infants. The mechanism may relate to reduced airway oedema and inflammation and reduced airway obstruction.

Factors associated with growth of extremely premature infants during initial hospitalization.

OBJECTIVE: To quantify the factors associated with growth of very small premature infants during initial hospitalization. POPULATION: Study patients were 109 infants who were appropriate for gestational age, weighed <1000 g at birth, and were fed intravenous hyperalimentation then calcium-supplemented 81-kcal preterm formula according to a protocol. ANALYSIS: Multiple regression analysis was performed for periods of 0 to 56, 0 to 14, and 15 to 56 days of age. Growth was determined as change in weight during the period. Variables assessed in the initial model were caloric intake, protein intake, respiratory support duration, patent ductus arteriosus, dexamethasone use, infection, birth weight ratio (weight divided by expected intrauterine weight for gestation), gestational age, sex, calendar time from study start, maternal betamethasone administration, and necrotizing enterocolitis. For the 0 to 14-day period, maximum oxygen requirement for respiratory distress syndrome replaced respiratory support duration, and 5-minute Apgar score was added, whereas dexamethasone and necrotizing enterocolitis were deleted. RESULTS: Mean change in weight was 785 g for 0 to 56 days, -16 g for 0 to 14 days, and 770 g for 15 to 56 days. Mean weight was 94% (13 SD) of mean intrauterine at birth, 73% (10 SD) at 14 days, and 73% (12 SD) at 56 days. Regression models explained 85%, 43%, and 80%, respectively, of variation in growth. Of the initial variables assessed, the following were the independent prognostic determinants of growth. There was a positive association with caloric intake at 0 to 56 days and 15 to 56 days, and with protein intake at 0 to 14 days. Negative associations were found for birth weight ratio and gestational age at 0 to 56 and 0 to 14 days. Respiratory support duration was negatively associated at 15 to 56 days, and dexamethasone was negatively associated at 0 to 56 and 15 to 56 days. Formulas to predict growth were established from the final regression models. CONCLUSION: The growth failure in appropriate-for-gestational-age, <1000-g birth weight infants can be related in part to dexamethasone use and respiratory support duration. Increasing caloric intake and early protein intake improves growth. However, for the majority of these patients, early losses are not corrected completely by 56 days using currently recommended intakes.

Growth of very premature infants fed intravenous hyperalimentation and calcium-supplemented formula.

OBJECTIVE: To describe growth during initial hospitalization for very small premature infants fed intravenous hyperalimentation, then calcium supplemented 1460 mg/L (36.5 mmol/L) 81 kcal preterm formula. POPULATION: A total of 109 survivors whose <1000 g birth weight was appropriate for gestational age. Mean gestational age was 25.8 weeks. RESULTS: Graphs were constructed for weight, length, and head circumference by week of age. Mean and +/- 2 SD lines were depicted, with mean intrauterine growth lines for comparison. Separate graphs showed mean weight, length, and head circumference growth by 100 g birth weight cohorts. Mean Z scores based on normal intrauterine growth curves were calculated. Weight Z scores were -.35 at birth, -1.79 at 14 days, and -1.87 at 56 days. Length Z scores were -.32 at birth, -1.29 at 14 days, and -2.24 at 56 days. Head circumference Z scores were 0.01 at birth, -1.26 at 14 days, and -1.06 at 56 days. (Z score = [measured parameter - intrauterine mean for gestation]/intrauterine SD for gestation). Repeated-measures multivariate ANOVAs showed the following significant Z score changes. There were decreases in Z scores for weight, length, and head circumference between birth and 14 days and an additional decrease for length between 14 and 56 days. Head circumference Z scores increased from day 14 to day 56, but remained smaller at day 56 than at day 0. Initially, head circumference Z scores were better than weight or length (possibly because of late head measurement timing). At day 14, the Z scores for weight were lower than those for length and head circumference. At day 56, the head circumference Z scores were higher than those for length or weight. CONCLUSION: Compared with intrauterine standards, weight, length, and head circumference were all worse at day 56 than at birth, although there was relative head-sparing and weight growth paralleled intrauterine growth after 14 days. Length worsened from day 14 to day 56 in spite of the use of calcium and phosphorus-enriched formula.

Home health nurse patient care and coordination time. Health maintenance organization versus fee-for-service.

Home health nurse visit and care coordination time were compared between Medicare patients enrolled in an health maintenance organization (HMO) and in the traditional Medicare fee-for-service program. In home nurse visit time did not differ for the two groups. Coordination time per episode of care was approximately 40 minutes longer for an HMO patient. When home health administrators develop discounted visit rates for HMO contracts, they must include the extra coordination time in the rates.

Etiologic determinants of abruptio placentae.

OBJECTIVE: To quantify the roles of suspected sociodemographic, anthropometric, behavioral, and pathologic determinants in the etiology of abruptio placentae. METHODS: We performed a hospital-based cohort study of 36,875 nonreferred births between January 1978 and March 1989. Gestational age was based on menstrual dates confirmed (within 7 days) by early ultrasound. RESULTS: Parity, maternal education, pre-pregnancy weight, and the rate of net gestational weight gain did not have significant independent associations with abruption. Significant determinants included the following: severe small for gestational-age (SGA) birth (odds ratio [OR] 3.99; 95% confidence interval [CI] 2.75, 5.77), chorioamnionitis (OR 2.50; 95% CI 1.58, 3.98), prolonged rupture of membranes (OR 2.38; 95% CI 1.55, 3.65), preeclampsia (OR 2.05; 95% CI 1.39, 3.04), pregnancy-induced hypertension without albuminuria (OR 1.57; 95% CI 1.00, 2.46), pre-pregnancy hypertension (OR 1.77; 95% CI 1.05, 2.99), maternal age at least 35 years (OR 1.50; 95% CI 1.14, 2.01), unmarried status (OR 1.50; 95% CI 1.13, 1.98), cigarette smoking (OR 1.40; 95% CI 1.00, 1.97 for ten to 19 cigarettes per day and OR 1.13; 95% CI 0.81, 1.59 for at least 20 cigarettes per day), and male fetal gender (OR 1.38; 95% CI 1.12, 1.70). Removal of SGA from the regression model resulted in little change in the magnitude of the other associations. CONCLUSIONS: Severe fetal growth restriction, prolonged rupture of membranes, chorioamnionitis, hypertension (before pregnancy and pregnancy-induced), cigarette smoking, advanced maternal age, unmarried status, and male fetal gender are significant etiologic determinants of placental abruption. Non-SGA determinants appear to operate largely independently of their effects on fetal growth.

Causes of fetal death in women of advanced maternal age.

OBJECTIVE: To examine which causes of fetal death occur more often in older women and to determine whether these causes have changed significantly since the 1960 s and early 1970 s. METHODS: Data from the McGill Obstetrical Neonatal Database were used to calculate rates of specific causes of fetal death in women younger than 35 and in women 35 years or older. Among the 101,640 births between 1961 and 1995, there were 715 stillbirths and 822 neonatal deaths. The autopsy rate was 97% and categorization of the causes of fetal death remained consistent over this 34-year period. The rates of specific causes of fetal death per 10,000 total births were determined for an earlier period (1961-1974) and a later period (1978-1995). RESULTS: Compared with the 1961-1974 period, there was a 60% reduction in the rates of both fetal and neonatal deaths during 1978-1995 (P < .001). During 1961-1974, women 35 years or older were more likely than their younger counter-parts to have fetal death due to lethal congenital anomalies (odds ratio [OR] 3.2; 95% confidence interval [CI] 1.5, 6.5); this was no longer true in the 1978-1995 period. From 1978 to 1995, older women were at a statistically significant increased risk for "unexplained" fetal death (OR 2.2; 95% CI 1.3, 3.8); women 35 years of age or older had approximately one in 440 births end in unexplained fetal death, compared to one in 1000 births for women younger than 35. CONCLUSIONS: Advanced maternal age is no longer associated with an increased risk for fetal death due to congenital anomalies. However, older women have a significantly higher risk for unexplained fetal death. The identification of those maternal and fetal characteristics that contribute to unexplained fetal death and its prevention remain important challenges for contemporary obstetric practice.

How to measure the effectiveness of quality assurance.

Measuring is an essential component of any Total Quality Management System. In the Good Laboratory Practices arena this normally is done by measuring the quality of the customer's (e.g. Toxicology) output. This paper describes a holistic approach to measuring the effectiveness of the Quality Assurance Unit (QAU), which includes measures of both the customer and the QAU. When taken together, these measures provide management with a picture of the effectiveness of the QAU.

Recurrent respiratory distress syndrome in successive preterm pregnancies.

BACKGROUND: Earlier studies suggesting an increased recurrence risk of respiratory distress syndrome (RDS) among the subsequent infants of women with a previously affected infant were based on low birth weight inclusion criteria that did not differentiate between preterm and growth-retarded infants. METHODS: We therefore carried out two cohort studies of women who delivered two singleton preterm (gestational age < 37 completed weeks) infants: 1978 to 1989 at the Royal Victoria Hospital (RVH) in Montreal and 1959 to 1966 in the United States Collaborative Perinatal Project (CPP). We compared the relative risk (RR) of the development of RDS in the second infant according to the RDS status of the first. The diagnosis of RDS was based on respiratory distress of more than 24 hours' duration and a reticulogranular pattern on a chest radiograph. RESULTS: The RVH study sample comprised 284 infants born to 142 women, and the CPP sample 642 infants born to 321 mothers. In the RVH cohort the crude RR of RDS in the second sibling was 3.3 (95% confidence interval = 1.0 to 15.1) in women whose first preterm infant had RDS versus those whose first preterm infant did not have RDS. In the CPP cohort the corresponding RR was 2.5 (95% confidence interval = 0.8 to 7.9). These elevated risks were not altered substantially when multiple logistic regression was used to control for potentially confounding factors known to influence the risk of RDS (gestational age, sex, route of delivery, antenatal corticosteroids, and respiratory depression of birth). CONCLUSIONS: We conclude that preterm infants born to women with a previous preterm infant affected by RDS are at an increased risk of RDS, which suggests an important genetic (or other familial) tendency in its origin.

Possible new variant of Nijmegen breakage syndrome.

We report on a child with microcephaly, small facial and body size, and immune deficiency. The phenotype is consistent with Nijmegen breakage syndrome (NBS), with additional clinical manifestations and laboratory findings not reported heretofore. Most investigations, including the results of radiation-resistant DNA synthesis, concurred with the diagnosis of NBS. Cytogenetic analysis documented abnormalities in virtually all cells examined. Along with the high frequency of breaks and rearrangements of chromosomes 7 and 14, we found breakage and monosomies involving numerous other chromosomes. Because of some variation in the clinical presentation and some unusual cytogenetic findings, we suggest that our patient may represent a new variant of Nijmegen breakage syndrome.

Successful pregnancy complicated by peritonitis in a 35- year old CAPD patient.

A 35-year old woman conceived six months after initiating continuous ambulatory peritoneal dialysis (CAPD). A medical plan was developed to give the patient adequate dialysis for a 1.5 g/kg/day protein intake. In addition, alterations in calcium, magnesium, and erythropoietin administration were required to reach the objectives set by the obstetrical/renal team. Three weeks prior to delivery, an amniotic leak developed, and vaginal cultures were positive for Escherichia coli. Oral amoxicillin was administered (500 mg per os q.i.d.) until the day of delivery. A 1545-g baby girl was delivered by cesarean section at 32 weeks. Five days postpartum the patient developed severe peritonitis, which subsequently grew E. coli. The patient fully recovered from the peritonitis, but catheter removal was required. Successful pregnancy can be expected on CAPD, and adequacy can be achieved with aggressive dialysis. Cesarean section delivery should probably be accompanied by full peritonitis therapy.

Developing an effective toxicology/quality assurance partnership. Improving quality, compliance, and cooperation.

Toxicology and Quality Assurance (QA) at Eli Lilly and Company are well integrated, yet still independent organizations that are aligned with the same overall business objective: to efficiently deliver a high-quality product to the customer. One of the keys to success has been the implementation of a monitoring/metric and trend analysis program of key work processes that are central to the delivery of final product. Our metrics program indicates that the multiple changes that we have made have resulted in a higher quality product. This paper will discuss the practical changes we have made as a part of our Total Quality journey. This article is based solely on the authors' experiences while at Eli Lilly and Company.

Increased maternal age and the risk of fetal death.

BACKGROUND: Although the fetal death rate has declined over the past 30 years among women of all ages, it is unknown whether particular characteristics of the mother, such as age, still affect the risk of fetal death. We undertook a study to determine whether older age, having a first child (nulliparity), or other characteristics of the mother are risk factors for fetal death. METHODS: We used data from the McGill Obstetrical Neonatal Database to evaluate risk factors for fetal death among all deliveries at the Royal Victoria Hospital in Montreal (n = 94,346) from 1961 through 1993. Data were available for two time periods (1961 through 1974 and 1978 through 1993); data for 1975 through 1977 have not been entered into the data base and were therefore not included. Using logistic regression, we estimated the effect of specific maternal characteristics and complications of pregnancy on the risk of fetal death. RESULTS: The fetal death rate decreased significantly from 11.5 per 1000 total births (including live births and stillbirths) in the 1960s to 3.2 per 1000 in 1990 through 1993 (P < 0.001). Between these periods, the average maternal age at delivery increased from 27 to 30 years (P < 0.001), and the frequency of the diagnosis of diabetes and hypertension during pregnancy increased fivefold (P < 0.001). Nevertheless, after we controlled for these and other maternal characteristics, women 35 years of age or older continued to have a significantly higher rate of fetal death than their younger counterparts (odds ratio for women 35 to 39 years of age as compared with women < 30 years of age, 1.9; 95 percent confidence interval, 1.3 to 2.7; for those 40 or older, 2.4; 95 percent confidence interval, 1.3 to 4.5). CONCLUSIONS: Changes in maternal health and obstetrical practice have resulted in a 70 percent decline in the rate of fetal death among pregnant women of all ages since the 1960s. Advancing maternal age, however, continues to be a risk factor for fetal death.