Five years to the Term Breech Trial: the rise and fall of a randomized controlled trial.
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Biomedical subjects
Publications and source records attributed to Mary Hannah.
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A shortened cervix is often considered to be equivalent to cervical insufficiency, and a cerclage may be offered as an intervention to prolong pregnancy; however, we may not be differentiating between true cervical insufficiency and intrauterine causes of cervical shortening. A recent meta-analysis found no significant reduction in preterm birth < 35 weeks' gestation in women with cerclage compared with no cerclage in the total population of women studied. However, there was a potentially significant reduction in preterm birth < 35 weeks among women with a singleton pregnancy (relative risk [RR] 0.74; 95% confidence intervals [CI] 0.57-0.96), with a singleton pregnancy and a previous preterm birth (RR 0.61; 95% CI 0.40-0.92), and with a singleton pregnancy with a previous mid-trimester loss (RR 0.57; 95% CI 0.33-0.99). An increase was found in preterm birth among twin gestations with cerclage placed for a shortened cervix on transvaginal ultrasound (RR 2.15; 95% CI 1.15-4.01). This unexpected finding underscores the possibility of harm with this intervention. This intervention deserves further study. A national registry or database would allow us to identify women who may benefit more significantly from cerclage by collecting data on possible confounding effects such as concomitant intrauterine infection or placental disease.
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BACKGROUND: The decreased use of electronic fetal monitoring (EFM) for healthy women in labour and the increased provision of professional support to all women in labour is recommended by experts. We evaluated the effectiveness of a community-wide approach to transferring research results to practice using a regional committee, newsletter articles and annual conference presentations compared with an additional tailored hospital intervention involving workshops to enhance self-efficacy for nurses, policy review, multidisciplinary meetings, rounds and unit discussions. METHODS: We compared the proportion of women at low risk who received EFM and the proportion of nurses' time spent providing labour support before and after the intervention within each of 4 hospitals (2 tertiary and 2 secondary). One hospital of either type was randomly selected to receive the tailored intervention. Randomly selected charts (n = 200) were reviewed for the use of EFM at each hospital before (1995) and after (1996) the intervention. Trained observers at randomly selected times recorded the nurses' activities, including time spent providing labour support before and after the intervention. RESULTS: At the intervention secondary hospital, there was a large decrease in the use of EFM, from 90.1% before to 41.0% after the intervention (p < 0.001), but no change in nurses' time spent providing labour support. At the intervention tertiary hospital there was no change in EFM rates, but there was a small, statistically significant increase in time spent providing labour support (23.5% to 29.8%, p < 0.001). A negative effect on time spent providing labour support was found at the control secondary hospital (decrease from 19.6% to 12.8%, p < 0.001), with no change in the EFM rate. At the control tertiary hospital there was a small decrease in the use of EFM, from 99.5% to 91.4% (p < 0.001), but no change in time spent providing labour support. INTERPRETATION: The results are mixed, and the tailored intervention thus appeared to have limited effects. No association was found between the reduction in the use of EFM and an increase in nurses' time spent providing labour support.
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OBJECTIVE: The purpose of this review was to assess the effects of repeated doses of antenatal corticosteroids on lung and brain function and on growth restriction in animals. STUDY DESIGN: MEDLINE and EMBASE were searched for randomized controlled trials that compared repeated doses of antenatal corticosteroids versus a single dose, with or without placebo, in pregnant animals. RESULTS: Nineteen studies were included. The animals that were studied included sheep, monkeys, rabbits, and mice. There were 8 studies that assessed the effects of repeated doses of antenatal corticosteroids on lung function. All the studies reported improvement in lung function after repeated doses of antenatal corticosteroids. Seven studies investigated the effects of repeated doses of antenatal corticosteroids on brain or nervous system function or growth; all the studies found adverse effects with repeated doses of antenatal corticosteroids. Eleven studies looked at the effect of repeated doses of antenatal corticosteroids on fetal growth. Nine studies found evidence of fetal growth restriction with repeated doses of antenatal corticosteroids. One study assessed long-term behavioral outcomes in mice and found no effect. CONCLUSION: Evidence from randomized controlled trials in animals suggests that repeated doses of antenatal corticosteroids may have beneficial effects in terms of lung function but may have adverse effects on brain function and fetal growth. Because of the differences between animals and humans, it is difficult to extrapolate directly the results of these studies to humans. Therefore, randomized controlled trials in humans are needed to assess the effects of repeated courses of antenatal corticosteroids for pregnant women who are at increased risk of preterm birth in terms of important perinatal, neonatal, and maternal outcomes.
OBJECTIVE: The purpose of this study was to compare the outcomes of pregnancy after transabdominal cerclage versus after transvaginal cerclage in patients with a failed transvaginal cerclage during a previous pregnancy. STUDY DESIGN: MEDLINE and EMBASE were searched in English. We included studies that reported perinatal and/or maternal outcomes in women who had a transabdominal cerclage or a transvaginal cerclage placed at or before 20 weeks of gestation, after having had a failed nonemergent transvaginal cerclage in a previous pregnancy. Data were included for individual patients if they met the inclusion criteria, and their outcomes were reported separately. We excluded patients with cervical amputation because transvaginal cerclage is not an option for these women because of technical difficulty. RESULTS: Fourteen studies met the inclusion criteria. Thirteen of the studies were case series (12 retrospective and 1 prospective), and one study was a retrospective cohort study. In total, 157 women in the studies had a failed vaginal cerclage in a previous pregnancy; 117 women had a subsequent transabdominal cerclage; 40 women had a subsequent transvaginal cerclage. The likelihood of perinatal death or delivery at <24 weeks was 6.0% (95% CI, 3.8%-8.2%) after transabdominal cerclage and 12.5% (95% CI, 2.7%-22.7%) after transvaginal cerclage. The likelihood of serious operative complications after transabdominal cerclage was 3.4% (95% CI, 0.01%, 6.8%). There were no serious operative complications after transvaginal cerclage. CONCLUSION: Transabdominal cerclage may be associated with a lower risk of perinatal death or delivery at <24 weeks of gestation, but it may be associated with a higher risk of serious operative complications. A multicenter randomized controlled trial should be conducted to address this question.