Cohort profile: The promotion of breastfeeding intervention trial (PROBIT).

The PROmotion of Breastfeeding Intervention Trial (PROBIT) is a multicentre, cluster-randomized controlled trial conducted in the Republic of Belarus, in which the experimental intervention was the promotion of increased breastfeeding duration and exclusivity, modelled on the Baby-friendly hospital initiative. Between June 1996 and December 1997, 17,046 mother-infant pairs were recruited during their postpartum hospital stay from 31 maternity hospitals, of which 16 hospitals and their affiliated polyclinics had been randomly assigned to the arm of PROBIT investigating the promotion of breastfeeding and 15 had been assigned to the control arm, in which breastfeeding practices and policies in effect at the time of randomization was continued. Of the mother-infant pairs originally recruited for the study, 16,492 (96.7%) were followed at regular intervals until the infants were 12 months of age (PROBIT I) for the outcomes of breastfeeding duration and exclusivity; gastrointestinal and respiratory infections; and atopic eczema. Subsequently, 13,889 (81.5%) of the children from these mother-infant pairs were followed-up at age 6.5 years (PROBIT II) for anthropometry, blood pressure (BP), behaviour, dental health, cognitive function, asthma and atopy outcomes, and 13,879 (81.4%) children were followed to the age of 11.5 years (PROBIT III) for anthropometry, body composition, BP, and the measurement of fasted glucose, insulin, adiponectin, insulin-like growth factor-I, and apolipoproteins. The trial registration number for Current Controlled Trials is ISRCTN37687716 and that for ClinicalTrials.gov is NCT01561612. Proposals for collaboration are welcome, and enquires about PROBIT should be made to an executive group of the study steering committee (M.S.K., R.M.M., and E.O.). More information, including information about how to access the trial data, data collection documents, and bibliography, is available at the trial website (http://www.bristol.ac.uk/social-community-medicine/projects/probit/).

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 METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2013). SELECTION CRITERIA: All published and unpublished randomised 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 review 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 average risk ratio (RR) for categorical data and mean difference (MD) for continuous data. MAIN RESULTS: Twenty-two trials involving 15,288 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% confidence interval (CI) 1.04 to 1.12) and less likely to have intrapartum analgesia (RR 0.90, 95% CI 0.84 to 0.96) or to report dissatisfaction (RR 0.69, 95% CI 0.59 to 0.79). In addition, their labours were shorter (MD -0.58 hours, 95% CI -0.85 to -0.31), they were less likely to have a caesarean (RR 0.78, 95% CI 0.67 to 0.91) or instrumental vaginal birth (fixed-effect, RR 0.90, 95% CI 0.85 to 0.96), regional analgesia (RR 0.93, 95% CI 0.88 to 0.99), or a baby with a low five-minute Apgar score (fixed-effect, RR 0.69, 95% CI 0.50 to 0.95). There was no apparent impact on other intrapartum interventions, maternal or neonatal complications, or breastfeeding. Subgroup analyses suggested that continuous support was most effective when the provider 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.

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.

Antenatal care packages with reduced visits and perinatal mortality: a secondary analysis of the WHO antenatal care trial - Comentary: routine antenatal visits for healthy pregnant women do make a difference.

The practice and timing of routine antenatal visits for healthy pregnant women, introduced arbitrarily and without evidence of effectiveness, have become entrenched in obstetric practice over the last century. In 2001 the large, cluster randomized WHO Antenatal Care Trial concluded that a goal-orientated package of antenatal care with reduced visits seemed not to affect maternal and perinatal outcomes. The reduced visit package has been implemented in several countries. The current re-analysis finds that the significantly increased perinatal mortality which occurred in the reduced visit package persists after adjustment for potential confounding factors. The WHO Antenatal Care Trial provided the first evidence from a randomized trial that the traditional high frequency of routine visits in the third trimester may well reduce perinatal mortality.

Understanding the moral nature of intrapartum nursing.

OBJECTIVE: To explore how intrapartum nurses understand and negotiate their moral responsibilities toward women during childbirth. DESIGN: Qualitative critical narrative. SETTING: Labor and birth unit in an urban Canadian hospital. PARTICIPANTS: Fourteen intrapartum registered nurses. METHODS: Critical narrative analysis using a feminist ethics perspective. RESULTS: Nurses understood their moral responsibilities to laboring women in a variety of ways depending on the nurses' personal and professional experiences, the people involved, and the context of care. Four themes were identified: organizing and coordinating care, responding to the unpredictable, recognizing limits of responsibilities to others, and negotiating care with women and families. A key factor influencing responses to women was the degree to which expectations related to birth were deemed to be reasonable and mutually agreed upon among nurses, physicians, women, and their families. Although nurses were able to identify contextual influences that constrained their ability to maintain effective relationships with women, the influence of their own values on the care they provided was less apparent. Nurses also described limits of their responsibilities for others, which departed from the idealized expectations often reflected in professional guidelines CONCLUSION: These findings suggest a need to challenge assumptions related to the provision of choice and family centered care to create environments that can support and sustain understanding and trust between nurses and women giving birth. In addition, given the lack of shared understandings of what constitutes best care, there is a need to develop collaborative models of care that include the voices of women as a central component.

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 METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2012). SELECTION CRITERIA: All published and unpublished randomised 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 review 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 average risk ratio (RR) for categorical data and mean difference (MD) for continuous data. MAIN RESULTS: Twenty-two trials involving 15,288 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% confidence interval (CI) 1.04 to 1.12) and less likely to have intrapartum analgesia (RR 0.90, 95% CI 0.84 to 0.96) or to report dissatisfaction (RR 0.69, 95% CI 0.59 to 0.79). In addition, their labours were shorter (MD -0.58 hours, 95% CI -0.85 to -0.31), they were less likely to have a caesarean (RR 0.78, 95% CI 0.67 to 0.91) or instrumental vaginal birth (fixed-effect, RR 0.90, 95% CI 0.85 to 0.96), regional analgesia (RR 0.93, 95% CI 0.88 to 0.99), or a baby with a low five-minute Apgar score (fixed-effect, RR 0.69, 95% CI 0.50 to 0.95). There was no apparent impact on other intrapartum interventions, maternal or neonatal complications, or breastfeeding. Subgroup analyses suggested that continuous support was most effective when the provider 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 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 setting. Secondary: to determine if the effects of birth settings are influenced by staffing, architectural features, organizational models or geographical location. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 March 2012). SELECTION CRITERIA: All randomized or quasi-randomized controlled trials which compared the effects of an alternative institutional birth setting to a conventional setting. DATA COLLECTION AND ANALYSIS: We used the standard methods of the Cochrane Collaboration Pregnancy and Childbirth Group. Two review authors evaluated methodological quality. We performed double data extraction and presented results using risk ratios (RR) and 95% confidence intervals (CI). MAIN RESULTS: Ten trials involving 11,795 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/anesthesia (six trials, n = 8953; RR 1.18, 95% CI 1.05 to 1.33); spontaneous vaginal birth (eight trials; n = 11,202; RR 1.03, 95% CI 1.01 to 1.05); 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 (eight trials, n = 10.931; RR 0.80, 95% CI 0.74 to 0.87); oxytocin augmentation of labour (eight trials, n = 11,131; RR 0.77, 95% CI 0.67 to 0.88); instrumental vaginal birth (eight trials, n = 11,202; RR 0.89, 95% CI 0.79 to 0.99), and episiotomy (eight trials, n = 11,055; RR 0.83, 95% CI 0.77 to 0.90). There was no apparent effect on other adverse maternal or neonatal outcomes. Care by the same or separate staff had no apparent effects. No conclusions could be drawn regarding the effects of continuity of caregiver or architectural characteristics. In several of the trials included in this review, the design features of the alternative setting were confounded by important differences in the organizational models for care (separate staff for the alternative setting, offering more continuity of caregiver), and thus it is difficult to draw inferences about the independent effects of the physical birth environment. AUTHORS' CONCLUSIONS: Hospital birth centres are associated with lower rates of medical interventions during labour and birth and higher levels of satisfaction, without increasing risk to mothers or babies.

Mind-body interventions during pregnancy for preventing or treating women's anxiety.

BACKGROUND: Anxiety during pregnancy is a common problem. Anxiety and stress could have consequences on the course of the pregnancy and the later development of the child. Anxiety responds well to treatments such as cognitive behavioral therapy and/or medication. Non-pharmacological interventions such as mind-body interventions, known to decrease anxiety in several clinical situations, might be offered for treating and preventing anxiety during pregnancy. OBJECTIVES: To assess the benefits of mind-body interventions during pregnancy in preventing or treating women's anxiety and in influencing perinatal outcomes. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2010), MEDLINE (1950 to 30 November 2010), EMBASE (1974 to 30 November 2010), the National Center for Complementary and Alternative Medicine (NCCAM) (1 December 2010), ClinicalTrials.gov (December 2010) and Current Controlled Trials (1 December 2010), searched the reference lists of selected studies and contacted professionals and authors in the field. SELECTION CRITERIA: Randomized controlled trials, involving pregnant women of any age at any time from conception to one month after birth, comparing mind-body interventions with a control group. Mind-body interventions include: autogenic training, biofeedback, hypnotherapy, imagery, meditation, prayer, auto-suggestion, tai-chi and yoga. Control group includes: standard care, other pharmacological or non-pharmacological interventions, other types of mind-body interventions or no treatment at all. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for inclusion all assessed risk of bias for each included study. We extracted data independently using an agreed form and checked it for accuracy. MAIN RESULTS: We included eight trials (556 participants), evaluating hypnotherapy (one trial), imagery (five trials), autogenic training (one trial) and yoga (one trial). Due to the small number of studies per intervention and to the diversity of outcome measurements, we performed no meta-analysis, and have reported results individually for each study. Compared with usual care, in one study (133 women), imagery may have a positive effect on anxiety during labor decreasing anxiety at the early and middle stages of labor (MD -1.46; 95% CI -2.43 to -0.49; one study, 133 women) and (MD -1.24; 95% CI -2.18 to -0.30). Another study showed that imagery had a positive effect on anxiety and depression in the immediate postpartum period. Autogenic training might be effective for decreasing women's anxiety before delivering. AUTHORS' CONCLUSIONS: Mind-body interventions might benefit women's anxiety during pregnancy. Based on individual studies, there is some but no strong evidence for the effectiveness of mind-body interventions for the management of anxiety during pregnancy. The main limitations of the studies were the lack of blinding and insufficient details on the methods used for randomization.

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.

An internet-based self-management program with telephone support for adolescents with arthritis: a pilot randomized controlled trial.

OBJECTIVE: To determine the feasibility of a 12-week Internet-based self-management program of disease-specific information, self-management strategies, and social support with telephone support for youth with juvenile idiopathic arthritis (JIA) and their parents, aimed at reducing physical and emotional symptoms and improving health-related quality of life (HRQOL). METHODS: A nonblind pilot randomized controlled trial (NCT01011179) was conducted to test the feasibility of the "Teens Taking Charge: Managing Arthritis Online" Internet intervention across 4 tertiary-level centers in Canada. Participants were 46 adolescents with JIA, ages 12 to 18 years, and 1 parent for each participant, who were randomized to the control arm (n = 24) or the Internet intervention (n = 22). RESULTS: The 2 groups were comparable on demographic and disease-related variables and treatment expectation at baseline. Attrition rates were 18.1% and 20.8%, respectively, from experimental and control groups. Ninety-one percent of participants randomized to the experimental group completed all 12 online modules and weekly phone calls with a coach in an average of 14.7 weeks (SD 2.1). The control group completed 90% of weekly attention-control phone calls. The Internet treatment was rated as acceptable by all youth and their parents. In posttreatment the experimental group had significantly higher knowledge (p < 0.001, effect size 1.32) and lower average weekly pain intensity (p = 0.03, effect size 0.78). There were no significant group differences in HRQOL, self-efficacy, adherence, and stress posttreatment. CONCLUSION: Findings support the feasibility (acceptability, compliance, and user satisfaction) and initial efficacy of Internet delivery of a self-management program for improving disease-specific knowledge and reducing pain in youth with JIA.

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.

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.

WITHDRAWN: Continuity of caregivers for care during pregnancy and childbirth.

BACKGROUND: Care during pregnancy, childbirth, and the postnatal period is often provided by multiple caregivers, many of whom work only in the antenatal clinic, labour ward or postnatal unit. However continuity of care is provided by the same caregiver or a small group from pregnancy through the postnatal period. OBJECTIVES: The objective of this review was to assess continuity of care during pregnancy and childbirth and the puerperium with usual care by multiple caregivers. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register was searched. Date of last search: April 2000. SELECTION CRITERIA: Controlled trials comparing continuity of care with usual care during pregnancy, childbirth and the postnatal period. DATA COLLECTION AND ANALYSIS: Trial quality was assessed. Study authors were contacted for additional information. MAIN RESULTS: Two studies involving 1815 women were included. Both trials compared continuity of care by midwives with non-continuity of care by a combination of physicians and midwives. The trials were of good quality. Compared to usual care, women who had continuity of care from a team of midwives were less likely to be admitted to hospital antenatally (odds ratio 0.79, 95% confidence interval 0.64 to 0.97) and more likely to attend antenatal education programs (odds ratio 0.58, 95% confidence interval 0.41 to 0.81). They were also less likely to have drugs for pain relief during labour (odds ratio 0.53, 95% confidence interval 0.44 to 0.64) and their newborns were less likely to require resuscitation (odds ratio 0.66, 95% confidence interval 0.52 to 0.83). No differences were detected in Apgar scores, low birthweight and stillbirths or neonatal deaths. While they were less likely to have an episiotomy (odds ratio 0.75, 95% confidence interval 0.60 to 0.94), women receiving continuity of care were more likely to have either a vaginal or perineal tear (odds ratio 1.28, 95% confidence interval 1.05, 1.56). They were more likely to be pleased with their antenatal, intrapartum and postnatal care. AUTHORS' CONCLUSIONS: Studies of continuity of care show beneficial effects. It is not clear whether these are due to greater continuity of care, or to midwifery care.

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.

The costs of planned cesarean versus planned vaginal birth in the Term Breech Trial.

BACKGROUND: The Term Breech Trial compared the safety of planned cesarean and planned vaginal birth for breech presentations at term. The combined outcome of perinatal or neonatal death and serious neonatal morbidity was found to be significantly lower among babies delivered by planned cesarean section. In this study we conducted a cost analysis of the 2 approaches to breech presentations at delivery. METHODS: We used a third-party-payer (i.e., Ministry of Health) perspective. We included all costs for physician services and all hospital-related costs incurred by both the mother and the infant. We collected health care utilization and outcomes for all study participants during the trial. We used only the utilization data from countries with low national rates of perinatal death (< or = 20/1000). Seven hospitals across Canada (4 teaching and 3 community centres) were selected for unit cost calculations. RESULTS: The estimated mean cost of a planned cesarean was significantly lower than that of a planned vaginal birth (7165 dollars v. 8042 dollars per mother and infant; mean difference -877 dollars, 95% credible interval -1286 dollars to -473 dollars). The estimated mean cost of a planned cesarean was lower than that of a planned vaginal birth for both women having a first birth (7255 dollars v. 8440 dollars) and women having had at least one prior birth (7071 dollars v. 7559 dollars). Although the treatment effect was largest in the subgroup of women having their first child, there was no statistically significant interaction between treatment and parity since the 95% credible intervals for difference in treatment effects between parity equalling zero and parity of one or greater all include zero. INTERPRETATION: Planned cesarean section was found to be less costly than planned vaginal birth for the singleton fetus in a breech presentation at term in the Term Breech Trial.

Mothers' views of their childbirth experiences 2 years after planned Caesarean versus planned vaginal birth for breech presentation at term, in the international randomized Term Breech Trial.

OBJECTIVE: To compare mothers' views at 2 years postpartum after participation in a randomized trial of planned Caesarean and planned vaginal birth for a singleton fetus in breech presentation at term. STUDY DESIGN: In selected centres in the Term Breech Trial, mothers completed a structured questionnaire at approximately 2 years postpartum to assess their likes and dislikes about their childbirth experiences and their views about their intrapartum care and care providers. RESULTS: Of 1159 mothers from 85 centres, 917 (79.1%) completed a follow-up questionnaire at 2 years postpartum. Baseline information was similar for both the planned Caesarean and planned vaginal birth groups. Planned Caesarean was associated with less worry about the baby's health (P < 0.001). While other differences were noted in likes and dislikes about their childbirth experiences, women's evaluations of the quality of intrapartum care, the helpfulness of staff, and their involvement in decision-making did not differ in the planned Caesarean delivery and planned vaginal birth groups. CONCLUSION: Planned mode of delivery influences aspects of women's evaluations of their childbirth experiences but does not affect evaluations of the quality of intrapartum care, support from care providers, or amount of involvement in decision-making.

The effect of unrestricted oral carbohydrate intake on labor progress.

OBJECTIVE: To determine if unrestricted oral carbohydrate intake during labor reduced the incidence of dystocia in low-risk nulliparous women. DESIGN AND SETTING: A randomized clinical trial at a university-affiliated hospital in southeastern Ontario. Low-risk nulliparous women were randomized between 30 and 40 weeks gestation to either an intervention or usual care group. INTERVENTION: Women in the intervention group received, prenatally, guidelines about food and fluid intake during labor and were encouraged to eat and drink as they pleased during labor. Women in the usual care group received no prelabor information and were restricted to ice chips and water during labor in the hospital. MAIN OUTCOME MEASURE: The incidence of dystocia, defined as a cervical dilatation rate of less than 0.5 cm/hr for a period of 4 hrs after a cervical dilatation of 3 cm. RESULTS: Three hundred twenty-eight women were randomized to the intervention (n = 163) or usual care (n = 165) groups. Women in the intervention group reported a significantly different pattern of oral intake during early labor in the hospital (chi(2) = 40.7, p < .001). The incidence of dystocia was 36% (n = 58) in the intervention group and 44% (n = 72) in the usual care group and was not significantly different (OR = 0.71, 95% CI = 0.46, 1.11). There were no significant differences in the other secondary outcomes or in the incidence of adverse maternal or neonatal complications. CONCLUSION: Eating and drinking early in labor had no significant impact on the incidence of dystocia and/or adverse maternal or neonatal outcomes.

Outcomes of children at 2 years after planned cesarean birth versus planned vaginal birth for breech presentation at term: the International Randomized Term Breech Trial.

OBJECTIVE: The purpose of this study was to determine whether planned cesarean delivery for the singleton fetus in breech presentation at term reduces the risk of death or neurodevelopmental delay at 2 years of age. STUDY DESIGN: In selected centers in the Term Breech Trial, children were screened for abnormalities at > or =2 years of age with the Ages and Stages Questionnaire, followed by a neurodevelopmental assessment if the Ages and Stages Questionnaire score was abnormal. RESULTS: A total of 923 of 1159 children (79.6%) from 85 centers were followed to 2 years of age. The risk of death or neurodevelopmental delay was no different for the planned cesarean than for the planned vaginal birth groups (14 children [3.1%] vs 13 children [2.8%]; relative risk, 1.09; 95% CI, 0.52- 2.30; P = .85; risk difference, +0.3%; 95% CI, -1.9%, +2.4%). CONCLUSION: Planned cesarean delivery is not associated with a reduction in risk of death or neurodevelopmental delay in children at 2 years of age.

Maternal outcomes at 2 years after planned cesarean section versus planned vaginal birth for breech presentation at term: the international randomized Term Breech Trial.

OBJECTIVE: This study was undertaken to compare maternal outcomes at 2 years postpartum after planned cesarean section and planned vaginal birth for the singleton fetus in breech presentation at term. STUDY DESIGN: In selected centers in the Term Breech Trial, mothers completed a structured questionnaire at 2 or more years postpartum to determine their health in the previous 3 to 6 months. RESULTS: A total of 917 of 1159 (79.1%) mothers from 85 centers completed a follow-up questionnaire at 2 years postpartum. There were no differences between groups in breast feeding, relationship with child or partner, pain, subsequent pregnancy, incontinence, depression, urinary, menstrual or sexual problems, fatigue, or distressing memories of the birth experience. Planned cesarean section was associated with a higher risk of constipation (P = .02). CONCLUSION: Maternal outcomes at 2 years postpartum are similar after planned cesarean section and planned vaginal birth for the singleton breech fetus at term.