Women's views of their experiences in the CHIPS (Control of Hypertension in Pregnancy Study) Pilot Trial.

BACKGROUND: Satisfaction with maternity care is strongly related to the patient-caregiver relationship and involvement in the decision-making process. We sought to compare women's views about their care in a randomized trial of 'less tight' vs. 'tight' control of non-proteinuric pre-existing or gestational hypertension in pregnancy. METHODS: In the CHIPS Pilot Trial, women completed a postpartum questionnaire to assess their likes and dislikes about their blood pressure (BP) management and trial participation. Comparisons were descriptive. RESULTS: Baseline information was similar for the 'less tight' and 'tight' control groups. Of 132 women, 126 (95.5%) from 17 centers completed a postpartum questionnaire, usually within days of delivery. At least 90% of women in both groups were satisfied with their care, and would be willing to participate again or recommend participation to a friend. Women in both the 'less tight' and 'tight' groups were satisfied with BP management (98.4% vs. 95.1%), and the frequency of tests of maternal and fetal well being. Half of women in both groups perceived that their BP was too high and that caregivers thought that their BP was too high. More women in the 'less tight' (vs. the 'tight') control group took less medication than expected (71.7% vs. 38.2%). More women in the 'tight' (vs. the 'less tight') group took more medication than they expected (60.0% vs. 22.2%). At least 60% of all women used home BP monitoring. CONCLUSION: In the CHIPS Pilot Trial, while women stated that they were satisfied with their BP management and care, a surprising 50% in both groups thought that their BP was too high. The majority of women used home BP monitoring, the role of which must be further defined in hypertensive pregnancies.

The Control of Hypertension In Pregnancy Study pilot trial.

OBJECTIVE: To determine whether 'less tight' (versus 'tight') control of nonsevere hypertension results in a difference in diastolic blood pressure (dBP) between groups. DESIGN: Randomised controlled trial (ISRCTN#57277508). SETTING: Seventeen obstetric centres in Canada, Australia, New Zealand, and UK. POPULATION: Inclusion: pregnant women, dBP 90-109 mmHg, pre-existing/gestational hypertension; live fetus(es); and 20-33(+6) weeks. Exclusion: systolic blood pressure > or = 170 mmHg and proteinuria, contraindication, or major fetal anomaly. METHODS: Randomisation to less tight (target dBP, 100 mmHg) or tight (target dBP, 85 mmHg) blood pressure control. MAIN OUTCOME MEASURES: Primary: mean dBP at 28, 32 and 36 weeks. Secondary: clinician compliance and women's satisfaction. Other: serious perinatal and maternal complications. RESULTS: A total of 132 women were randomised to less tight (n = 66; seven had no study visit) or tight control (n= 66; one was lost to follow up; seven had no study visit). Mean dBP was significantly lower with tight control: -3.5 mmHg, 95% credible interval (-6.4, -0.6). Clinician compliance was 79% in both groups. Women were satisfied with their care. With less tight (versus tight) control, the rates of other treatments and outcomes were the following: post-randomisation antenatal antihypertensive medication use: 46 (69.7%) versus 58 (89.2%), severe hypertension: 38 (57.6%) versus 26 (40.0%), proteinuria: 16 (24.2%) versus 20 (30.8%), serious maternal complications: 3 (4.6%) versus 2 (3.1%), preterm birth: 24 (36.4%) versus 26 (40.0%), birthweight: 2675 +/- 858 versus 2501 +/- 855 g, neonatal intensive care unit (NICU) admission: 15 (22.7%) versus 22 (34.4%), and serious perinatal complications: 9 (13.6%) versus 14 (21.5%). CONCLUSION: The CHIPS pilot trial confirms the feasibility and importance of a large definitive trial to determine the effects of less tight control on serious perinatal and maternal complications.

Women's views regarding participation in a proposed randomized controlled trial of twin delivery.

OBJECTIVE: To determine the views of women regarding participation in a proposed multicentre randomized controlled trial comparing planned vaginal birth to planned Caesarean delivery for twins at 32 or more weeks' gestation, in which the first twin (twin A) is presenting as a vertex. METHODS: Pregnant women with a known twin gestation were recruited from 2 hospital centres. Written information was provided about the proposed Twin Birth Study, and the women were then requested to complete a questionnaire to determine their views regarding participation in the proposed trial. RESULTS: Of the 64 women recruited for the study, 31 (48%) indicated they would be willing to consider participating in the proposed trial (95% CI, 37-60%), 14 (22%) were unsure about trial participation (95% CI, 13-33%), and 19 (30%) indicated they would not be willing to participate in the proposed study (95% CI, 20-42%). The most common reason for agreement to participation was altruism (n = 28). Those who responded "not sure" wished to speak with their partner (n = 5) or their doctor (n = 8) before deciding on participation. Of those who indicated they would not participate in the proposed trial, 12 (63%) indicated they preferred to have a vaginal birth, and 7 (37%) preferred to have a Caesarean section. CONCLUSIONS: Almost half the women in our sample were agreeable to considering their participation in a randomized trial that will compare planned vaginal birth to planned Caesarean section for twins at 32 or more weeks' gestation with twin A presenting as a vertex. Altruism was the most common reason for agreeing to participate, whereas preference for a specific mode of delivery was the most common reason for declining participation.

Prenatal diagnosis for arginase deficiency: a case study.

Arginase deficiency is a rare, autosomal recessive, disorder of the urea cycle characterized by mild hyperammonaemia, hyperargininaemia, dibasic aminoaciduria and orotic aciduria, associated with progressive spastic tetraplegia, seizures, psychomotor retardation, and growth failure. We report a family who presented with their daughter at 4 years 11 months of age with an acute encephalopathy. Initial laboratory results revealed hyperammonaemia (160 micromol/L; normal 0-34), hyperargininaemia (512 micromol/L; normal 23-86) and orotic aciduria. A diagnosis of arginase deficiency was confirmed by enzyme assay, and treatment with a modified protein-restricted diet along with sodium benzoate therapy was initiated. Over time, intellectual development has been normal, but the child developed spasticity in her lower extremities. Subsequently, the mother presented at 6 weeks of pregnancy seeking prenatal diagnosis. Prenatal testing for arginase deficiency has only been reported in one other case. Arginase is not expressed in cultured amniotic fluid cells or chorionic villus samples. Testing for arginase activity assay in red blood cells, isolated by cordocentesis, was performed and predicted an unaffected fetus. The result was confirmed by postnatal enzyme analysis of red cells from the newborn. On the basis of our experience, prenatal diagnosis of arginase deficiency by cord red blood cell arginase activity assay appears possible.

Serious perinatal complications of non-proteinuric hypertension: an international, multicentre, retrospective cohort study.

OBJECTIVE: To determine the proportion of births complicated by either a pre-existing or a gestational non-proteinuric hypertension, presenting at <34 weeks' gestation, and the associated incidence with 1 or more serious perinatal complications or birth weight <3rd centile for gestational age. METHODS: A retrospective chart review was conducted in 5 international centres, from 1998 to 2002, where "tight" control (normalization) of blood pressure (BP) is the norm. International Classification of Diseases (ICD) codes were used to identify women who delivered at > or =20 weeks' gestation, with any hypertensive disorder of pregnancy. Women were included if they had a diastolic blood pressure (dBP) of 90 to 109 mm Hg, due to either a pre-existing or a gestational non-proteinuric hypertension, presenting at <34 weeks' gestation. Women were excluded if they had ongoing severe hypertension, or if at presentation with dBP of 90 to 109 mm Hg, they had 1 or more of the following: proteinuria, an indication for "tight" control of BP or imminent delivery, or a known intrauterine fetal death or lethal fetal anomaly. Data were collected on paper forms, scanned into an electronic database, and summarized descriptively by type of hypertension. RESULTS: There were 305 eligible women (0.7% deliveries, 12.8% hypertensive deliveries) identified with non-proteinuric hypertension that was either pre-existing (133 [43.6%]) or gestational (172 [56.4%]). Regardless of hypertension type, 16.4% (n = 50) of pregnancies were complicated by birth weight <3rd centile or 1 or more serious perinatal complications, 34.3% (n = 100) by preterm birth, 30.8% (n = 94) by preeclampsia, and 2.0% (n = 6) by serious maternal complications. CONCLUSION: Non-proteinuric pre-existing or gestational hypertension, presenting before 34 weeks' gestation, identifies a subpopulation of hypertensive pregnant women at both substantial perinatal risk and maternal risk. The CHIPS (Control of Hypertension In Pregnancy Study) trial is designed to determine how best to manage the hypertension of such women in order to optimize perinatal outcome.

Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Term Breech Trial Collaborative Group.

BACKGROUND: For 3-4% of pregnancies, the fetus will be in the breech presentation at term. For most of these women, the approach to delivery is controversial. We did a randomised trial to compare a policy of planned caesarean section with a policy of planned vaginal birth for selected breech-presentation pregnancies. METHODS: At 121 centres in 26 countries, 2088 women with a singleton fetus in a frank or complete breech presentation were randomly assigned planned caesarean section or planned vaginal birth. Women having a vaginal breech delivery had an experienced clinician at the birth. Mothers and infants were followed-up to 6 weeks post partum. The primary outcomes were perinatal mortality, neonatal mortality, or serious neonatal morbidity; and maternal mortality or serious maternal morbidity. Analysis was by intention to treat. FINDINGS: Data were received for 2083 women. Of the 1041 women assigned planned caesarean section, 941 (90.4%) were delivered by caesarean section. Of the 1042 women assigned planned vaginal birth, 591 (56.7%) delivered vaginally. Perinatal mortality, neonatal mortality, or serious neonatal morbidity was significantly lower for the planned caesarean section group than for the planned vaginal birth group (17 of 1039 [1.6%] vs 52 of 1039 [5.0%]; relative risk 0.33 [95% CI 0.19-0.56]; p<0.0001). There were no differences between groups in terms of maternal mortality or serious maternal morbidity (41 of 1041 [3.9%] vs 33 of 1042 [3.2%]; 1.24 [0.79-1.95]; p=0.35). INTERPRETATION: Planned caesarean section is better than planned vaginal birth for the term fetus in the breech presentation; serious maternal complications are similar between the groups.

Role clarity, perception of the organization and burnout amongst support workers in residential homes for people with intellectual disability: a comparison between a National Health Service trust and a charitable company.

Changes in roles and responsibilities brought about by community care and the reorganization of the UK National Health Service (NHS) have resulted in higher levels of stress and insecurity amongst residential nursing staff working with people with intellectual disability. In the light of these organizational changes, questions have arisen about the relationship between role clarity, perception of the organization and occupational stress. A number of studies have investigated these issues amongst staff working with people with intellectual disability, although there have been few investigations in the UK. The present study examines the relationship between these variables in the context of the differences between the employees of an NHS trust and a charitable organization. The present study involved constructing a measure of role clarity and perception of the organization, and the use of the Maslach Burnout Inventory (MBI). The results indicated that most support workers regarded their role as being clear and their levels of burnout to be comparable with UK nursing norms. Charity staff were more likely to view their organization positively and rated their emotional exhaustion as significantly lower than NHS trust staff. A within-service comparison of homes revealed differences amongst NHS trust and charity homes on sub-scales of the MBI. The results are discussed in the context of previous research and changes in working practices in the field.

Induction of labour versus expectant management for prelabour rupture of the membranes at term: an economic evaluation. TERMPROM Study Group. Term Prelabour Rupture of the Membranes.

BACKGROUND: As the interval between rupture of the fetal membranes at term and delivery increases, so may the risk of fetal and maternal infection. Recently the TERMPROM (Term Prelabor Rupture of the Membranes) Study Group reported the results of a randomized controlled trial comparing 4 management strategies: induction with oxytocin (IwO), induction with prostaglandin (IwP), and expectant management and induction with either oxytocin (EM-O) or prostaglandin (EM-P) if complications developed. The study found no statistically significant differences in neonatal infection and cesarean section rates between any of the 4 groups. OBJECTIVE: To conduct an economic evaluation comparing the cost of (a) IwO and EM-O, (b) IwP and EM-P and (c) IwO and IwP. DESIGN: An economic analysis, conducted alongside the clinical trial, using a third-party payer perspective. Analysis included all treatment costs incurred for both the mother and the baby. Information on health care utilization and outcomes was collected for all study participants. Three countries (Canada, the United Kingdom and Australia), corresponding to the largest study recruitment, were chosen for calculation of unit costs. For each country, the base, low and high estimates of unit cost for each service item were generated. Intention-to-treat analysis. Extensive statistical and sensitivity analyses were performed. RESULTS: The median cost of IwO per patient was significantly lower statistically than that of EM-O and IwP. This result held in all 3 countries compared -$114 and -$46 in Canada, -113 Pounds and -63 Pounds in the UK, and -A$30 and -A$49 in Australia) and after an extensive sensitivity analysis. There was no statistically significant difference in median cost per patient between IwP and EM-P. CONCLUSION: Although the clinical results of the TERMPROM study did not find IwO to be preferable to the other treatment alternatives, the economic evaluation found it to be less costly. However, these cost differences, even though statistically significant, are not likely to be important in many countries. When this is the case, the authors recommend that women be offered a choice between management strategies.

International Multicentre Term Prelabor Rupture of Membranes Study: evaluation of predictors of clinical chorioamnionitis and postpartum fever in patients with prelabor rupture of membranes at term.

OBJECTIVES: Our purpose was to determine significant predictors for the development of clinical chorioamnionitis and postpartum fever in patients with prelabor rupture of membranes at term. STUDY DESIGN: Logistic regression analysis with odds ratios and 95% confidence intervals was used to determine the significant predictors of clinical chorioamnionitis and postpartum fever in women with prelabor rupture of membranes at term enrolled in this study. The study recently compared in a randomized controlled trial four strategies of management: induction with oxytocin, induction with prostaglandin, expectant management, and, if failed, induction with oxytocin or prostaglandin. RESULTS: The following variables were significantly associated with clinical chorioamnionitis: (1) number of digital vaginal examinations: > 8, 7 to 8, 5 to 6, 3 to 4 (vs 0 to 2) (odds ratio 5.07, 3.80, 2.62, 2.06); (2) duration of active labor: > or = 12, 9 to < 12, 6 to < 9 hours (vs < 3 hours) (odds ratio 4.12, 2.94, 1.97); (3) meconium-stained amniotic fluid (odds ratio 2.28); (4) parity of 0 (odds ratio 1.80); (5) time from membrane rupture to active labor: > or = 48, 24 to < 48 hours (vs < 12 hours) (odds ratio 1.76, 1.77); and (6) group B streptococcal colonization (odds ratio 1.71). Variables significantly associated with postpartum fever were (1) clinical chorioamnionitis (odds ratio 5.37), (2) duration of active labor: > or = 12, 9 to < 12, 6 to < 9, 2 to < 6 hours (vs < 3 hours) (odds ratio 4.86, 3.53, 3.46, 3.04), (3) cesarean section, operative vaginal delivery (odds ratio 3.97, 1.86), (4) group B streptococcal colonization (odds ratio 1.88), and (5) maternal antibiotics before delivery (odds ratio 1.94). CONCLUSIONS: Increasing numbers of digital vaginal examinations, longer duration of active labor, and meconium staining of the amniotic fluid were the most important risk factors for the development of clinical chorioamnionitis in women with prelabor rupture of membranes at term. The most important risk factors for the development of postpartum fever were clinical chorioamnionitis, increasing duration of active labor, and cesarean section delivery.

Evaluation of an educational program to prevent adolescent pregnancy.

The authors evaluated the effectiveness of a school-based sex education program in decreasing rates of sexual intercourse, improving birth control use, and decreasing the incidence of pregnancies among teenagers 16 years of age and younger. Twenty-one schools received either the McMaster Teen Program or the conventional didactic sex education program. Preprogram, the mean age of the students was 12.6 years. There were no statistically significant differences between groups in time to first sexual activity for males, chi 2(1) = 2.93, p = 0.09; time to first sexual activity for females, chi 2(1) = 0.50, p = 0.48; and time to first pregnancy, chi 2(1) = 1.90, p = 0.17. Significantly more experimental group males reported always using birth control at year 1 (difference 8.9%; 95% confidence interval [CI] = 0.4, 17.4). Limitations of the program that may have influenced the results were the exclusion of contraception information and its short duration.

Women's evaluations of induction of labor versus expectant management for prelabor rupture of the membranes at term. TermPROM Study Group.

BACKGROUND: Induction of labor has become common practice in many Western countries, but few studies have assessed women's views. METHODS: A randomized, controlled trial was conducted at 72 hospitals in six countries. Five thousand forty-one women meeting eligibility criteria, with no contraindications for induction of labor or expectant management, were randomly assigned to four groups: induction with intravenous oxytocin, induction with vaginal prostaglandin E2 gel, or expectant management followed by induction with either oxytocin or with prostaglandin E2 gel if complications developed. The three main outcome measures were evaluations of the treatment received, perceived control during childbirth, and evaluations of the experience of trial participation. RESULTS: Questionnaires were completed by 81.9 percent of the sample. No significant differences occurred between the two induction groups. Compared with the expectant management groups, induced women were less likely to report there was nothing they liked about their treatment and less likely to report that the treatment caused additional worry. No between-group differences occurred in experienced control during childbirth. Women in the induction groups were more likely to be willing to participate in the study again and to feel reassured. CONCLUSIONS: Women's preferences should be considered when making decisions about their method of management when membranes rupture before labor. Obtaining participants' views is both feasible and worthwhile when evaluating forms of medical care.

A controlled trial of nurse practitioners in neonatal intensive care.

OBJECTIVE: To compare a clinical nurse specialist/neonatal practitioner (CNS/NP) team with a pediatric resident team in the delivery of neonatal intensive care. DESIGN: Randomized, controlled trial. SETTING: A 33-bed tertiary-level neonatal intensive care unit. PATIENTS: Of 821 infants admitted to the neonatal intensive care unit between September 1991 and September 1992, 414 were randomized to care by the CNS/NP team, and 407 were randomized to care by the pediatric resident team. INTERVENTION: Infants assigned to the CNS/NPs team were cared for by CNS/NPs during the day and by pediatric residents during the night. Infants assigned to the pediatric resident team were cared for by pediatric residents around the clock. Neonatologists supervised both teams. MEASURES: Outcome measures included mortality; number of neonatal complications; length of stay; quality of care, as assessed by a quantitative indicator condition approach; parent satisfaction with care, measured using the Neonatal Index of Parent Satisfaction; long-term outcomes, measured using the Minnesota Infant Development Inventory; and costs. RESULTS: There were 19 (4.6%) deaths in the CNS/NP group and 24 (5.9%) in the resident group (relative risk [RR], 0.78; confidence interval [CI], 0.43 to 1.40). In the CNS/NP group, 230 (55.6%) neonates had complications, in comparison with 220 (54.1%) in the resident group (RR, 1.03; CI 0.91 to 1.16). Mean lengths of stay were 12.5 days in the CNS/NP group and 11.7 days in the resident group (difference in means, 0.8 days; CI, -1.1 to 2.7). The performance on the indicator conditions was comparable in the two groups except for two instances, jaundice and charting, both of which favored the CNS/NP group. Mean scores on the Neonatal Index of Parent Satisfaction were 140 in the CNS/NP group and 139 in the resident group (difference in means, 1.0; CI, -3.6 to 5.6). In the CNS/NP group, 6 (2.6%) infants performed 30% or more below their age level in the Minnesota Infant Development Inventory, in comparison with 2 (0.9%) in the resident group (RR, 2.87; CI, 0.59 to 14.06) The cost per infant in the CNS/NP group was $14,245 and in the resident group $13,267 (difference in means, $978; CI, -1303.18 to 3259.05). CONCLUSIONS: CNS/NP and resident teams are similar with respect to all tested measures of performance. These results support the use of CNS/NPs as an alternative to pediatric residents in delivering care to critically ill neonates.

Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group.

BACKGROUND: As the interval between rupture of the fetal membranes at term and delivery increases, so may the risk of fetal and maternal infection. It is not known whether inducing labor will reduce this risk or whether one method of induction is better then another. METHODS: We studied 5041 women with prelabor rupture of the membranes at term. The women were randomly assigned to induction of labor with intravenous oxytocin; induction of labor with vaginal prostaglandin E2 gel; or expectant management for up to four days, with labor induced with either intravenous oxytocin or vaginal prostaglandin E2 gel if complications developed. The primary outcome was neonatal infection. Secondary outcomes were the need for cesarean section and women's evaluations of their treatment. RESULTS: The rates of neonatal infection and cesarean section were not significantly different among the study groups. The rates of neonatal infection were 2.0 percent for the induction-with-oxytocin group, 3.0 percent for the induction-with-prostaglandin group, 2.8 percent for the expectant-management (oxytocin) group, and 2.7 percent for the expectant-management (prostaglandin) group. The rates of cesarean section ranged from 9.6 to 10.9 percent. Clinical chorioamnionitis was less likely to develop in the women in the induction-with-oxytocin group than in those in the expectant-management (oxytocin) group (4.0 percent vs. 8.6 percent, P<0.001), as was postpartum fever (1.9 percent vs. 3.6 percent, P=0.008). Women in the induction groups were less likely to say they liked "nothing" about their treatment than those in the expectant-management groups. CONCLUSIONS: In women with prelabor rupture of the membranes at term, induction of labor with oxytocin or prostaglandin E2 and expectant management result in similar rates of neonatal infection and cesarean section. Induction of labor with intravenous oxytocin results in a lower risk of maternal infection than does expectant management. Women view induction of labor more positively than expectant management.

Postterm pregnancy: putting the merits of a policy of induction of labor into perspective.

BACKGROUND: Several randomized, controlled trials compared the policies of induction of labor and expectant management for women who reach 41 weeks' gestation, and although they suggest a better outcome for mothers and infants with such a policy in place, controversy continues as to which is the better form of care. The Canadian Multicenter Postterm Pregnancy Trial (CMPPT) enrolled 3407 women, of whom 1701 were randomized to a policy of induction of labor (induced group) and 1706 were randomized to a policy of expectant management (expectant group). Secondary analyses of data from the CMPPT were undertaken to explore a number of controversial issues. METHODS: We used data from the CMPPT to explore further the timing of delivery for women enrolled between 41 0/7 and 41 6/7 weeks' gestation, the potential impact of more liberal use of prostaglandins on cesarean section rates, and the relative merits of induced versus spontaneous labor in the two groups. RESULTS: Most women in the CMPPT (89%) were enrolled at 41 0/7 to 41 6/7 weeks' gestation, of whom 86.2 percent in the induced group and 63.6 percent in the expectant group gave birth before 42 weeks' gestation. Assuming that administration of prostaglandins would reduce the likelihood of cesarean section by 12 to 15 percent, cesarean section rates were reduced in the induction group from 21.2 percent to 20.8 to 20.9 percent, and in the expectant group from 24.5 percent 23.3 to 24.2 percent. If labor was induced as part of a policy of expectant management, the cesarean section rate was much higher (33.5%) than if labor was either spontaneous or induced as part of a policy of induction (18.5%, 22.4%). CONCLUSIONS: Women should be informed of the benefits and risks associated with the policies of induction of labor and expectant management, and their preferences regarding these policies should be respected.

Cost-effectiveness of induction of labour versus serial antenatal monitoring in the Canadian Multicentre Postterm Pregnancy Trial.

OBJECTIVE: To determine the cost-effectiveness of induction of labour versus serial fetal monitoring while awaiting spontaneous labour in postterm pregnancies. DESIGN: Cost-effectiveness and cost-minimization analyses conducted as part of a Canadian multicentre randomized clinical trial. SETTING: Twenty-two Canadian hospitals, of which 19 were teaching hospitals and 3 were community hospitals. PATIENTS: Women with uncomplicated pregnancies of 41 or more weeks' gestation were randomly assigned to induction of labour or serial antenatal monitoring. Of the 3418 women enrolled, no data were received on 11. Therefore, results were based on data from 1701 women in the induction arm of the study and 1706 women in the monitoring arm. MAIN OUTCOME MEASURES: Perinatal mortality and neonatal morbidity, rates of cesarean section and health care costs. Hospital costing models were developed specifically for the study. Data on use of major resources (e.g., length of hospital stay, surgical procedures, major diagnostic tests and procedures, and medications) for all trial participants were collected and combined with data on minor tests and procedures (e.g., laboratory tests) abstracted from a detailed review of medical records of a sample of patients. RESULTS: Because the results of the clinical trial showed a nonsignificant difference in perinatal mortality and neonatal morbidity between the induction and monitoring arms, the authors conducted a cost-minimization rather than a cost-effectiveness analysis. The mean cost per patient with a postterm pregnancy managed through monitoring was $3132 (95% confidence interval [CI] $3090 to $3174) and per patient who underwent induction of labour was $2939 (95% CI $2898 to $2981), for a difference of $193. The significantly higher (p < 0.0001) mean cost per patient in the monitoring arm was due mainly to the costs of additional monitoring and the significantly higher rates of cesarean section among these patients. Estimated conservatively, the savings resulting from a universal policy of managing postterm pregnancies by induction of labour in Canada may be as high as $8 million a year. CONCLUSIONS: A policy of managing postterm pregnancy through induction of labour not only results in more favourable outcomes than a monitoring strategy but does so at a lower cost.

Induction of labor as compared with serial antenatal monitoring in post-term pregnancy. A randomized controlled trial. The Canadian Multicenter Post-term Pregnancy Trial Group.

BACKGROUND: The rates of perinatal mortality and neonatal morbidity are higher for post-term pregnancies than for term pregnancies. It is not known, however, whether the induction of labor results in better outcomes than does serial fetal monitoring while awaiting spontaneous labor. METHODS: We studied 3407 women with uncomplicated pregnancies of 41 or more weeks' duration. The women were randomly assigned to undergo induction of labor or to have serial antenatal monitoring and spontaneous labor unless there was evidence of fetal or maternal compromise, in which case labor was induced or cesarean section was performed. In the induction group, labor was induced by the intracervical application of prostaglandin E2. Serial antenatal monitoring consisted of counts of fetal kicks, nonstress tests, and assessments of amniotic-fluid volume. The outcomes we measured were the rates of perinatal mortality, neonatal morbidity, and delivery by cesarean section. RESULTS: Among the 1701 women in the induction group, 360 (21.2 percent) underwent cesarean section, as compared with 418 (24.5 percent) of the 1706 women in the monitoring group (P = 0.03). This difference resulted from a lower rate of cesarean section performed because of fetal distress among the women in the induction group (5.7 percent vs. 8.3 percent, P = 0.003). When two infants with lethal congenital anomalies were excluded, there were no perinatal deaths in the induction group and two stillbirths in the monitoring group (P not significant). The frequency of neonatal morbidity was similar in the two groups. CONCLUSIONS: In post-term pregnancy, the induction of labor results in a lower rate of cesarean section than serial antenatal monitoring; the rates of perinatal mortality and neonatal morbidity are similar with the two approaches to management.

Home blood pressure-measuring devices: a comparative study of accuracy.

Self monitoring of blood pressure by hypertensive patients has been shown to be of value and is increasingly popular. However, the accuracy and ease of use of at least some of the equipment for home use is questionable. We tested 23 pairs of home blood pressure devices, using static methods, trained observers with volunteer subjects and hypertensive patients. Eleven (48%) of the 23 pairs of devices tested were found inconsistent with their duplicate and failed the standards for automated devices of the Association for the Advancement of Medical Instrumentation. Several of the devices, all sold for home use by lay people, contained no instructions whatsoever and even patients using those machines with instructions required further training in blood pressure measurement. While home blood pressure monitoring is useful in certain circumstances, care must be taken in the choice of device, and training is required for all devices.

Are chronic digestive complaints the result of abnormal dietary patterns? Diet and digestive complaints in children at 22 and 40 months of age.

We studied 149 healthy children at 22 months of age and 74 at 40 months of age, employing a 24-hour dietary record based on premailed food measurement guide and telephone questionnaire. Parents cooperated in 94% of contacts. Chronic digestive complaints decreased from 27% to 5% of the sample over the study period: constipation from 16% to 3%, chronic diarrhea from 8% to 1%, and abdominal pain from 5% to 1%. Excessive fluid intake (1470 +/- 600 vs 840 +/- 300 mL/d) correlated most strongly for seven children at 22 months experiencing alternating symptoms of chronic diarrhea and constipation or abdominal pain. Many other children tolerated dietary extremes without complaint. All macronutrient categories except dietary fiber intake increased over the study period. Thus, excessive fluid intake may provoke symptoms suggesting the irritable bowel syndrome in a susceptible group of younger children. Failure to increase fiber intake from 22 to 40 months of age leaves children on an immature diet whose effects require further study.

Hypertension control in two Canadian communities: evidence for better treatment and overlabelling.

We evaluated the prevalence and control of hypertension in two Canadian cities without university medical centre facilities. A stratified multistage probability sample was selected, and we interviewed 6258 adults between the ages of 30 and 69 inclusive. Blood pressure measurements were obtained during home interviews. Up to two further visits were made to people with untreated blood pressure elevation. By a diagnostic criterion of 90 mmHg, the hypertension prevalence was 114/1000. Six per cent of the hypertensives were undetected, 6% detected but untreated, 17% treated but uncontrolled and 70% were being treated and controlled. Control was better in females and older subjects. These findings show no disadvantages to hypertensives living away from university medical centres. We found a hypertension prevalence of 143/1000 among people who reported being diagnosed as hypertensive but who had normal blood pressure while not on medication. These results suggest a problem with over-labelling of hypertensives.