A Sleep Hygiene and Relaxation Intervention for Children With Acute Lymphoblastic Leukemia: A Pilot Randomized Controlled Trial.

BACKGROUND: Sleep disturbance and fatigue are common and distressing pediatric cancer-related outcomes. Sleep hygiene education and relaxation techniques are recommended to improve sleep in healthy children and adult cancer survivors. No studies have tested these interventions to improve sleep and fatigue for children with acute lymphoblastic leukemia (ALL) in the home setting. OBJECTIVES: The aim of this study is to establish the feasibility and acceptability of a sleep hygiene and relaxation intervention to improve sleep and fatigue for children receiving maintenance chemotherapy for ALL. The child's fatigue and sleep data were collected to inform sample size calculations for a future trial. METHODS: In this pilot randomized controlled trial, 20 children were allocated randomly to the sleep intervention or control group. The sleep intervention group received a 60-minute educational session to discuss sleep and fatigue in children with cancer and strategies to improve sleep, including use of 2 storybooks to teach deep breathing and progressive muscle relaxation. Objective sleep data were collected using actigraphy and fatigue was measured using the Childhood Cancer Fatigue Scale. RESULTS: The intervention was acceptable to families, and feasibility of the intervention and data collection was clearly established. Although not statistically significant, increases in mean nighttime sleep and decreases in mean wake time after sleep onset in the sleep intervention group represented clinically important improvements. CONCLUSIONS: This pilot study demonstrated the feasibility and acceptability of a sleep hygiene and relaxation intervention for children undergoing maintenance chemotherapy for ALL. IMPLICATIONS FOR PRACTICE: Given the clinically important improvements in sleep observed, replication in a larger, adequately powered randomized controlled trial is merited.

Sleep, sleepiness, and fatigue outcomes for parents of critically ill children.

OBJECTIVES: To describe sleep quantity, sleep patterns, fatigue, and sleepiness for parents of critically ill hospitalized children. DESIGN: Prospective observational study. SETTING: Quaternary academic PICU. PARTICIPANTS: One hundred eighteen parents of 91 children recruited during their child's PICU stay. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: For 5 days and nights, parents wore an actigraph to determine objective sleep-wake times and reported sleep location, level of fatigue (Fatigue Visual Analogue Scale), and sleepiness (Stanford Sleepiness Scale). Mean amounts of nocturnal sleep were less than recommended for optimal health (398 min, fathers vs 422 min, mothers; p = 0.04). Parents woke frequently (7.8 wakes, fathers; 7.2 wakes, mothers) and spent over an hour awake at night (65 min, fathers; 60 min, mothers). On 130 nights (26%), parents slept less than 6 hours and 209 nights (44%) were evaluated as "worse" sleep than usual. Fifty-four parents (53%) experienced more than 30% difference in minutes of sleep between consecutive nights. Mean morning fatigue levels (41 mm, fathers vs 46 mm, mothers; p = 0.03) indicated clinically significant fatigue. Sleeping in a hotel, parent room, or residence was associated with 3.2 more wakes per night (95% CI, 0.61-5.78; p = 0.015) than sleeping in a hospital lounge or waiting room. CONCLUSIONS: We performed a prospective observational study of 118 parents of critically ill children using objective measures of sleep and validated scales to assess fatigue and sleepiness. We found that more than a quarter of nights met criteria for acute sleep deprivation, there was considerable variability in the amount of nocturnal sleep that individual participants slept on different nights, and sleep was fragmented with a large portion of the night spent awake. Future research should focus on interventions that improve parents' ability to return to sleep upon awakening and maintain regular sleep-wake schedules.

Repeated hands-and-knees positioning during labour: a randomized pilot study.

Background. Caesarean birth rates in North America continue to rise, in the absence of benefit for mothers and babies. One reason may be that hospitalized labouring women spend most of their labours in recumbent or semi-recumbent positions. Although hands-and-knees position has theoretical advantages, efforts to encourage its adoption in practice are severely hampered by the lack of compelling evidence that it is beneficial. Before a definitive, large scale trial, with spontaneous vaginal birth as the primary outcome, could be justified in terms of time, effort, and expense, several feasibility and acceptability questions had to be addressed. We aimed to enrol 60 women in a pilot study to assess feasibility and acceptability of the trial protocol, and to obtain estimates of treatment effects on method of birth and persistent back pain. Methods. We conducted a pilot study at two North American hospitals. In ten months of recruitment, 30 nulliparous women in labour at term were randomly allocated to either usual care (use of any position during labour except hands-and-knees) or to try hands-and-knees for 15 min every hour during labour. Data were collected about compliance, acceptability, persistent back pain, intrapartum interventions, and women's views of their experiences. Results. Although mean length of time from randomization to delivery was over 12 hours, only 9 of the 16 women allocated to repeated hands-and-knees used it more than twice. Two of the 14 in the usual care group used hands-and-knees once. Twenty-seven women had regional analgesia (15 in the hands-and-knees group and 12 in the usual care group). Eleven in the hands-and-knees group and 14 in the usual care group had spontaneous vaginal births. One woman (in the hands-and-knees group) had a vacuum extraction. Four women in the hands-and-knees group and none in the usual care group gave birth by caesarean section. Hourly back pain ratings were highly variable in both groups, covering the full range of possible scores. Given the low compliance with the hands-and-knees position, it was not possible to explore relationships between use of the position and persistent back pain scores. When asked to rate their overall satisfaction with their birth experiences, the hands-and-knees group's ratings tended to be lower than those in the usual care group, although 11 in the hands-and-knees group and 8 in the usual care group stated they would probably or definitely try the position in a subsequent labour. Conclusion. We concluded that we could not justify the time and expense associated with a definitive trial. However such a trial could be feasible with modifications to eligibility criteria and careful selection of suitable settings.

Effect of behavioural-educational intervention on sleep for primiparous women and their infants in early postpartum: multisite randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of a behavioural-educational sleep intervention delivered in the early postpartum in improving maternal and infant sleep. DESIGN: Randomised controlled trial. SETTING: Postpartum units of two university affiliated hospitals. PARTICIPANTS: 246 primiparous women and their infants randomised while in hospital with an internet based randomisation service to intervention (n=123) or usual care (n=123) groups. INTERVENTIONS: The behavioural-educational sleep intervention included a 45-60 minute meeting with a nurse to discuss sleep information and strategies to promote maternal and infant sleep, a 20 page booklet with the content discussed, and phone contacts at one, two, and four weeks postpartum to reinforce information, provide support, and problem solve. The usual care group received calls at weeks one, two, and four to maintain contact without provision of advice. MAIN OUTCOME MEASURES: Primary outcome was maternal nocturnal (9 pm to 9 am) sleep (minutes) and secondary outcome was longest stretch of infant nocturnal sleep (minutes) measured at six and 12 weeks postpartum by actigraphy. Other outcomes measured at six and 12 weeks were number of maternal and infant night time awakenings by actigraphy, fatigue visual analogue scale, general sleep disturbance scale, and Edinburgh postnatal depression scale. Rates of exclusive breast feeding were measured at 12 weeks postpartum only. RESULTS: All women who completed any outcome measures at six or 12 weeks were included in analysis. Sleep outcomes were completed at one or both of six and 12 weeks postpartum for 215 of 246 (87%) women (110/123 intervention and 105/123 usual care). Longitudinal mixed effects model analyses indicated no significant differences between the groups on any of the outcomes. The estimated mean difference in maternal nocturnal sleep between the intervention and usual care groups was 5.97 minutes (95% confidence interval -7.55 to 19.5 minutes, P=0.39). No differences in any outcomes were noted based on the specific nurse delivering the intervention or the number of phone contacts received. CONCLUSION: A behavioural-educational intervention delivered in the early postpartum, in hospital, and in the first weeks at home, was ineffective in improving maternal and infant sleep or other health outcomes in the first months postpartum. TRIAL REGISTRATION: ISRCT No 13501166.

Prospective economic evaluation of a peer support intervention for prevention of postpartum depression among high-risk women in Ontario, Canada.

OBJECTIVE: A previous multisite, randomized, controlled trial of peer support compared with usual care for prevention of postpartum depression demonstrated a reduction in depression symptoms at 12 weeks postbirth. Our objective was to determine the cost-effectiveness of this intervention. STUDY DESIGN: Prospectively planned economic evaluation alongside the clinical trial to determine the cost per case of postpartum depression averted, using individual patient data (n = 610) and societal perspective. All costs were expressed in 2011 Canadian dollars. RESULTS: The mean cost per woman was $4,497 in the peer support group and $3,380 in the usual care group (difference of $1,117, p < 0.0001). There was a 95% probability that the program would cost less than $20,196 per case of postpartum depression averted. CONCLUSIONS: Although this is a volunteer-based program, it results in a net cost to the health care system and society. However, this cost is within the range for other accepted interventions for this population.

Continuous support for women during childbirth.

BACKGROUND: Historically, women have been attended and supported by other women during labour. However in hospitals worldwide, continuous support during labour has become the exception rather than the routine. OBJECTIVES: Primary: to assess the effects of continuous, one-to-one intrapartum support compared with usual care. Secondary: to determine whether the effects of continuous support are influenced by: (1) routine practices and policies; (2) the provider's relationship to the hospital and to the woman; and (3) timing of onset. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 December 2010). SELECTION CRITERIA: All published and unpublished randomized controlled trials comparing continuous support during labour with usual care. DATA COLLECTION AND ANALYSIS: We used standard methods of the Cochrane Collaboration Pregnancy and Childbirth Group. Two authors independently evaluated methodological quality and extracted the data. We sought additional information from the trial authors. We used random-effects analyses for comparisons in which high heterogeneity was present, and we reported results using the risk ratio for categorical data and mean difference for continuous data. MAIN RESULTS: Twenty-one trials involving 15061 women met inclusion criteria and provided usable outcome data. Results are of random-effects analyses, unless otherwise noted. Women allocated to continuous support were more likely to have a spontaneous vaginal birth (RR 1.08, 95% CI 1.04 to 1.12) and less likely to have intrapartum analgesia (RR 0.90, 95% CI 0.84 to 0.97) or to report dissatisfaction (RR 0.69, 95% CI 0.59 to 0.79). In addition their labours were shorter (mean difference -0.58 hours, 95% CI -0.86 to -0.30), they were less likely to have a caesarean (RR 0.79, 95% CI 0.67 to 0.92) or instrumental vaginal birth (fixed-effect, RR 0.90, 95% CI 0.84 to 0.96), regional analgesia (RR 0.93, 95% CI 0.88 to 0.99), or a baby with a low 5-minute Apgar score (fixed-effect, RR 0.70, 95% CI 0.50 to 0.96). There was no apparent impact on other intrapartum interventions, maternal or neonatal complications, or on breastfeeding. Subgroup analyses suggested that continuous support was most effective when provided by a woman who was neither part of the hospital staff nor the woman's social network, and in settings in which epidural analgesia was not routinely available. No conclusions could be drawn about the timing of onset of continuous support. AUTHORS' CONCLUSIONS: Continuous support during labour has clinically meaningful benefits for women and infants and no known harm. All women should have support throughout labour and birth.

Alternative versus conventional institutional settings for birth.

BACKGROUND: Alternative institutional settings have been established for the care of pregnant women who prefer and require little or no medical intervention. The settings may offer care throughout pregnancy and birth, or only during labour; they may be part of hospitals or freestanding entities. Specially designed labour rooms include bedroom-like rooms, ambient rooms, and Snoezelen rooms. OBJECTIVES: Primary: to assess the effects of care in an alternative institutional birth environment compared to care in a conventional institutional setting. Secondary: to determine if the effects of birth settings are influenced by staffing, architectural features, organizational models or geographical location. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2010). SELECTION CRITERIA: All randomized or quasi-randomized controlled trials which compared the effects of an alternative institutional maternity care setting to conventional hospital care. DATA COLLECTION AND ANALYSIS: We used standard methods of the Cochrane Collaboration Pregnancy and Childbirth Group. Two review authors evaluated methodological quality. We performed double data entry and have presented results using risk ratios (RR) and 95% confidence intervals (CI). MAIN RESULTS: Nine trials involving 10684 women met the inclusion criteria. We found no trials of freestanding birth centres or Snoezelen rooms. Allocation to an alternative setting increased the likelihood of: no intrapartum analgesia/anaesthesia (five trials, n = 7842; RR 1.17, 95% CI 1.01 to 1.35); spontaneous vaginal birth (eight trials; n = 10,218; RR 1.04, 95% CI 1.02 to 1.06); breastfeeding at six to eight weeks (one trial, n = 1147; RR 1.04, 95% CI 1.02 to 1.06); and very positive views of care (two trials, n = 1207; RR 1.96, 95% CI 1.78 to 2.15). Allocation to an alternative setting decreased the likelihood of epidural analgesia (seven trials, n = 9820; RR 0.82, 95% CI 0.75 to 0.89); oxytocin augmentation of labour (seven trials, n = 10,020; RR 0.78, 95% CI 0.66 to 0.91); and episiotomy (seven trials, n = 9944; RR 0.83, 95% CI 0.77 to 0.90). There was no apparent effect on serious perinatal or maternal morbidity/mortality, other adverse neonatal outcomes, or postpartum hemorrhage. No firm conclusions could be drawn regarding the effects of variations in staffing, organizational models, or architectural characteristics of the alternative settings. AUTHORS' CONCLUSIONS: When compared to conventional settings, hospital-based alternative birth settings are associated with increased likelihood of spontaneous vaginal birth, reduced medical interventions and increased maternal satisfaction.

Effectiveness of percutaneous laser revascularization therapy for refractory angina.

Refractory angina is a debilitating disease characterized by persistent cardiac pain resistant to all conventional treatments for coronary artery disease. Percutaneous myocardial laser revascularization (PMLR) has been proposed to improve symptoms in these patients. We used meta-analysis to assess the effectiveness of PMLR versus optimal medical therapy for improving angina symptoms, health-related quality of life (HRQL), and exercise performance; the impact on all-cause mortality was also examined. Seven trials, involving a total of 1,213 participants were included. Our primary analyses showed that at 12-month follow-up, those who had received PMLR had ≥2 Canadian Cardiovascular Society class angina symptom reductions, OR 2.13 (95% CI, 1.22 to 3.73), as well as improvements in aspects of HRQL including angina frequency, SMD = 0.29 (95% CI, 0.05 to 0.52), disease perception, SMD = 0.37 (95% CI, 0.14 to 0.61), and physical limitations, SMD = 0.29 (95% CI, 0.05 to 0.53). PMLR had no significant impact on all-cause mortality. Our secondary analyses, in which we considered data from one trial that featured a higher-dose laser group, yielded no significant overall impact of PMLR across outcomes. While PMLR may be effective for improving angina symptoms and related burden, further work is needed to clarify appropriate dose and impact on disease-specific mortality and adverse cardiac events.

Support during pregnancy for women at increased risk of low birthweight babies.

BACKGROUND: Studies consistently show a relationship between social disadvantage and low birthweight. Many countries have programs offering special assistance to women thought to be at risk for giving birth to a low birthweight infant. These programs may include advice and counseling (about nutrition, rest, stress management, alcohol, and recreational drug use), tangible assistance (e.g., transportation to clinic appointments, household help), and emotional support. The programs may be delivered by multidisciplinary teams of health professionals, specially trained lay workers, or combination of lay and professional workers. OBJECTIVES: The primary objective was to assess effects of programs offering additional social support compared with routine care, for pregnant women believed at high risk for giving birth to babies that are either preterm or weigh less than 2500 gm, or both, at birth. Secondary objectives were to determine whether effectiveness of support was mediated by timing of onset (early versus later in pregnancy) or type of provider (healthcare professional or lay woman). SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2010). SELECTION CRITERIA: Randomized trials of additional support during at-risk pregnancy by either a professional (social worker, midwife, or nurse) or specially trained lay person, compared to routine care. We defined additional support as some form of emotional support (e.g., counseling, reassurance, sympathetic listening) and information or advice or both, either in home visits or during clinic appointments, and could include tangible assistance (e.g., transportation to clinic appointments, assistance with care of other children at home). DATA COLLECTION AND ANALYSIS: Two review authors evaluated methodological quality. We performed double data entry. MAIN RESULTS: We included 17 trials (12,264 women). Programs offering additional social support for at-risk pregnant women were not associated with improvements in any perinatal outcomes, but there was a reduction in the likelihood of antenatal hospital admission (three trials; n = 737; RR 0.79, 95% CI 0.68 to 0.92) and caesarean birth (nine trials; n = 4522; RR 0.87, 95% CI 0.78 to 0.97). AUTHORS' CONCLUSIONS: Pregnant women need the support of caring family members, friends, and health professionals. While programs which offer additional support during pregnancy are unlikely to prevent the pregnancy from resulting in a low birthweight or preterm baby, they may be helpful in reducing the likelihood of antenatal hospital admission and caesarean birth.

Hands-and-knees positioning during labor with epidural analgesia.

Hands-and-knees position has shown promise as an intervention to improve labor and birth outcomes, but no reports exist that examine its use with women laboring with epidural analgesia. Concerns of safety, effects on analgesia, and acceptability of use may limit use of active positioning during labor with regional analgesia. This article presents a case study series of 13 women who used hands-and-knees position in the first stage of labor.

Re-conceptualizing the hospital labor room: the PLACE (pregnant and laboring in an ambient clinical environment) pilot trial.

BACKGROUND: Nearly all hospitalized laboring women spend most of the time in bed. We made simple but radical modifications to a hospital labor room, which included the removal of the standard hospital bed and the addition of equipment to promote relaxation, mobility, and calm. We designed a pilot study, the objectives of which were to test the feasibility of a randomized trial and the acceptability of the modified labor room to women and their care providers. METHODS: Women were assessed and invited to participate just before their admission to the labor and delivery suite. Sixty-two women at two Toronto teaching hospitals were randomly allocated to either the standard labor room or the "ambient room." Data about labor and birth events were abstracted from the medical records. Participants and their nurses and physicians completed questionnaires to elicit their views of their experiences with the labor rooms. RESULTS: Women's and practitioners' evaluations of the ambient room were generally very positive. Nineteen women (65.5%) in the ambient group, compared with 4 (13.3%) in the standard group, reported spending 50 percent or less of their hospital labor in the standard labor bed. Twelve women allocated to the ambient room had artificial oxytocin infusions, compared with 21 allocated to the standard room (X (2) = 4.73, p = 0.03). CONCLUSION: We conclude that the ambient labor room should be evaluated in an adequately powered randomized controlled trial.

Effect on birth outcomes of a formalised approach to care in hospital labour assessment units: international, randomised controlled trial.

OBJECTIVE: To determine if a complex nursing and midwifery intervention in hospital labour assessment units would increase the likelihood of spontaneous vaginal birth and improve other maternal and neonatal outcomes. DESIGN: Multicentre, randomised controlled trial with prognostic stratification by hospital. SETTING: 20 North American and UK hospitals. PARTICIPANTS: 5002 nulliparous women experiencing contractions but not in active labour; 2501 were allocated to structured care and 2501 to usual care. INTERVENTIONS: Usual nursing or midwifery care or a minimum of one hour of care by a nurse or midwife trained in structured care, consisting of a formalised approach to assessment of and interventions for maternal emotional state, pain, and fetal position. MAIN OUTCOME MEASURES: Primary outcome was spontaneous vaginal birth. Other outcomes included intrapartum interventions, women's views of their care, and indicators of maternal and fetal health during hospital stay and 6-8 weeks after discharge. RESULTS: Outcome data were obtained for 4996 women. The rate of spontaneous vaginal birth was 64.0% (n=1597) in the structured care group and 61.3% (n=1533) in the usual care group (odds ratio 1.12, 95% confidence interval 0.96 to 1.27). Fewer women allocated to structured care (n=403, 19.5%) rated staff helpfulness as less than very helpful than those allocated to usual care (n=544, 26.4%); odds ratio 0.67, 98.75% confidence interval 0.50 to 0.85. Fewer women allocated to structured care (n=233, 11.3%) were disappointed with the amount of attention received from staff than those allocated to usual care (n=407, 19.7%); odds ratio 0.51, 98.75% confidence interval 0.32 to 0.70. None of the other results met prespecified levels of statistical significance. CONCLUSION: A structured approach to care in hospital labour assessment units increased satisfaction with care and was suggestive of a modest increase in the likelihood of spontaneous vaginal birth. Further study to strengthen the intervention is warranted. TRIAL REGISTRATION: Current Controlled Trials ISRCTN16315180.

Development of a deer mouse whole-genome radiation hybrid panel and comparative mapping of Mus chromosome 11 loci.

A 5000-rad whole-genome radiation hybrid cell panel (BW5000) was developed for mapping the deer mouse (Peromyscus maniculatus bairdii) genome. The panel consists of 103 cell lines and has an estimated marker retention frequency of 63.9% (range, 28%-88%) based on PCR typing of 30 Type I (coding gene) and 25 Type II (microsatellite) markers. Using the composite Mus map, Type I markers were selected from six Mus chromosomes, 22 of which are on Mus Chr 11. Fifteen of the Mus Chr 11 markers were simultaneously mapped on an interspecific (P. maniculatus x P. polionotus) backcross panel to test the utility of the radiation hybrid panel, create a framework map, and help establish gene order. The radiation hybrids have effectively detected linkage in the deer mouse genome between markers as far apart as 6.7 cM and resolved markers that are, in the Mus genome, as close as 0.2 Mb. Combined results from both panels have indicated a high degree of gene order conservation of the telomeric 64 cM of Mus Chr 11 in the deer mouse genome. The remaining centromeric portion also shows gene order conservation with the deer mouse but as a separate linkage group. This indicates a translocation of that portion of Mus Chr 11 in P. maniculatus and is consistent with rearrangement breakpoints observed between Mus and other mammalian genomes, including rat and human. Furthermore, this separate linkage group is likely to reside in a chromosomal region of inversion polymorphism between P. maniculatus and P. polionotus.

Randomized controlled trial of hands-and-knees positioning for occipitoposterior position in labor.

BACKGROUND: Hands-and-knees positioning during labor has been recommended on the theory that gravity and buoyancy may promote fetal head rotation to the anterior position and reduce persistent back pain. A Cochrane review found insufficient evidence to support the effectiveness of this intervention during labor. The purpose of this study was to evaluate the effect of maternal hands-and-knees positioning on fetal head rotation from occipitoposterior to occipitoanterior position, persistent back pain, and other perinatal outcomes. METHODS: Thirteen labor units in university-affiliated hospitals participated in this multicenter randomized, controlled trial. Study participants were 147 women laboring with a fetus at >or=37 weeks' gestation and confirmed by ultrasound to be in occipitoposterior position. Seventy women were randomized to the intervention group (hands-and-knees positioning for at least 30 minutes over a 1-hour period during labor) and 77 to the control group (no hands-and-knees positioning). The primary outcome was occipitoanterior position determined by ultrasound following the 1-hour study period and the secondary outcome was persistent back pain. Other outcomes included operative delivery, fetal head position at delivery, perineal trauma, Apgar scores, length of labor, and women's views with respect to positioning. RESULTS: Women randomized to the intervention group had significant reductions in persistent back pain. Eleven women (16%) allocated to use hands-and-knees positioning had fetal heads in occipitoanterior position following the 1-hour study period compared with 5 (7%) in the control group (relative risk 2.4; 95% CI 0.88-6.62; number needed to treat 11). Trends toward benefit for the intervention group were seen for several other outcomes, including operative delivery, fetal head position at delivery, 1-minute Apgar scores, and time to delivery. CONCLUSIONS: Maternal hands-and-knees positioning during labor with a fetus in occipitoposterior position reduces persistent back pain and is acceptable to laboring women. Given this evidence, hands-and-knees positioning should be offered to women laboring with a fetus in occipitoposterior position in the first stage of labor to reduce persistent back pain. Although this study demonstrates trends toward improved birth outcomes, further trials are needed to determine if hands-and-knees positioning promotes fetal head rotation to occipitoanterior and reduces operative delivery.

Effectiveness of nurses as providers of birth labor support in North American hospitals: a randomized controlled trial.

CONTEXT: North American cesarean delivery rates have risen dramatically since the 1960s, without concomitant improvements in perinatal or maternal health. A Cochrane Review concluded that continuous caregiver support during labor has many benefits, including reduced likelihood of cesarean delivery. OBJECTIVE: To evaluate the effectiveness of nurses as providers of labor support in North American hospitals. DESIGN: Randomized controlled trial with prognostic stratification by center and parity. Women were enrolled during a 2-year period (May 1999 to May 2001) and followed up until 6 to 8 postpartum weeks. SETTING: Thirteen US and Canadian hospitals with annual cesarean delivery rates of at least 15%. PARTICIPANTS: A total of 6915 women who had a live singleton fetus or twins, were 34 weeks' gestation or more, and were in established labor at randomization. INTERVENTION: Patients were randomly assigned to receive usual care (n = 3461) or continuous labor support by a specially trained nurse (n = 3454) during labor. MAIN OUTCOME MEASURES: The primary outcome measure was cesarean delivery rate. Other outcomes included intrapartum events and indicators of maternal and neonatal morbidity, both immediately after birth and in the first 6 to 8 postpartum weeks. RESULTS: Data were received for all 6915 women and their infants (n = 6949). The rates of cesarean delivery were almost identical in the 2 groups (12.5% in the continuous labor support group and 12.6% in the usual care group; P =.44). There were no significant differences in other maternal or neonatal events during labor, delivery, or the hospital stay. There were no significant differences in women's perceived control during childbirth or in depression, measured at 6 to 8 postpartum weeks. All comparisons of women's likes and dislikes, and their future preference for amount of nursing support, favored the continuous labor support group. CONCLUSIONS: In hospitals characterized by high rates of routine intrapartum interventions, continuous labor support by nurses does not affect the likelihood of cesarean delivery or other medical or psychosocial outcomes of labor and birth.

Crossing international boundaries: implications for the Term Breech Trial Data Coordinating Centre.

The Term Breech Trial (TBT) is a multicenter, international randomized trial that compared a policy of planned cesarean section with a policy of planned vaginal birth for selected pregnancies with a fetus in breech presentation at term. The TBT involved 121 centers in 26 countries that recruited 2088 women between January 9, 1997 and April 21, 2000. This paper briefly describes the impact of broad international collaboration on data coordinating center activities, including center selection, obtaining ethics approvals, data management, center funding, and recruitment.