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.

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.

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.

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.

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.

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.

Does a mailed continuing education program improve physician performance? Results of a randomized trial in antihypertensive care.

Evidence is sparse concerning the value of the "educational" materials that physicians receive in the mail. We conducted a randomized trial of a mailed continuing education program on hypertension for primary care physicians. Although formal pretesting documented that the program led to significant improvements in physician knowledge over the short term, the current study showed no lasting effect on physician knowledge (mean scores on an end-of-study questionnaire were 50% and 52% for study and control physicians, respectively) and no influence on performance in lowering the blood pressures of patients referred from screening (mean blood pressure drop for study patients, 12.2/10.4 mm Hg vs 13.0/10.6 mm Hg for control patients). The chance that we missed a difference in diastolic blood pressure as great as 3 mm Hg is less than 5%. Resources spent on instructional materials mailed to physicians may be wasted.