A Behavioral-Educational Intervention to Promote Pediatric Sleep During Hospitalization: A Pilot Randomized Controlled Trial.

OBJECTIVE/BACKGROUND: Hospitalization can contribute to common sleep difficulties in children. Interventions aimed at hospitalized children need to be developed and piloted with rigorous evaluative methods. The primary purpose of this study was to examine the feasibility and acceptability of a behavioral-educational intervention aimed at increasing nighttime sleep for hospitalized children. PARTICIPANTS: Hospitalized children aged 4-10 years and their caregivers. METHODS: A pilot randomized, controlled trial with concealed-group allocation was conducted. Forty-eight hospitalized children (ages 4-10) and their care-givers were randomized to either the Relax to Sleep (RTS) intervention group (n = 24) or the Usual Care (UC) comparison group (n = 24). The RTS intervention was comprised of a one-on-one educational session for the parent that was guided by a standardized booklet containing information on sleep and instructions for training the child in the use of a diaphragmatic breathing exercise. UC participants received no information about sleep or relaxation. Children wore actigraphs for 3 days and nights and completed sleep diaries. Outcome measures included feasibility, acceptability, and sleep outcomes. RESULTS: Parental reports indicated they enjoyed the discussion on sleep, found the information helpful, and their child found diaphragmatic breathing easy to use, and would use it again in the future. Children in the RTS group averaged 50 minutes more nighttime sleep, and had less wake after sleep onset time compared to children in the UC group. CONCLUSION: Sleep is critically important to children's health and well-being and should be given important consideration during hospitalization. Although the results of this pilot trial seem promising, more interventional studies are needed.

A Randomized Controlled Trial of an Individualized Preoperative Education Intervention for Symptom Management After Total Knee Arthroplasty.

Pain and nausea limit recovery after total knee arthroplasty (TKA) patients. The aim of this study was to determine the effect of a preoperative educational intervention on postsurgical pain-related interference in activities, pain, and nausea. Participants (n = 143) were randomized to intervention or standard care. The standard care group received the usual teaching. The intervention group received the usual teaching, a booklet containing symptom management after TKA, an individual teaching session, and a follow-up support call. Outcome measures assessed pain, pain interference, and nausea. There were no differences between groups in patient outcomes. There were no group differences for pain at any time point. Respondents had severe postoperative pain and nausea and received inadequate doses of analgesia and antiemetics. Individualizing education content was insufficient to produce a change in symptoms for patients. Further research involving the modification of system factors affecting the provision of symptom management interventions is warranted.

Evaluating the feasibility of a parent-briefing intervention in a pediatric acute care setting.

PURPOSE: The purpose of this study was to test the feasibility of a parent-briefing intervention for parents of hospitalized children with complex healthcare needs. DESIGN AND METHODS: A phase I, single-group, posttest study. There were 18 physicians, 25 nurses, and 31 parents who participated in the study. Participants were asked to sit while carrying out the briefings with parents. Parents and clinicians completed a feasibility questionnaire post briefings. RESULTS: Sixty-eight briefings were carried out. Parents and nurses evaluated the briefings in a favorable manner, whereas physicians' ratings were mixed. PRACTICE IMPLICATIONS: Further inquiry is recommended to understand the effects of a structured communication intervention on parent-professional decision-making practices.

Bourdieu at the bedside: briefing parents in a pediatric hospital.

The philosophy of family-centered care (FCC) promotes partnerships between families and staff to plan, deliver, and evaluate services for children and has been officially adopted by a majority of pediatric hospitals throughout North America. However, studies indicated that many parents have continued to be dissatisfied with their decision-making roles in their child's care. This is particularly salient for parents of children with chronic ongoing complex health problems. These children are dependent upon medical technology and require frequent hospitalizations during which parents must contribute to difficult decisions regarding their child's care. Given this clinical issue, an alternative theoretical perspective was explored to redress this problem. Pierre Bourdieu's theoretical concepts of field, capital, and habitus were used to analyze the hierarchical relationships in pediatric acute care hospitals and to design a briefing intervention aimed at improving parents' satisfaction with decision making in that health care setting.

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.

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.

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.

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 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.

A randomized controlled trial of the effect of intrapartum intravenous fluid management on breastfed newborn weight loss.

OBJECTIVE: To determine the effect of conservative versus usual intrapartum intravenous (IV) fluid management for low-risk women receiving epidural analgesia on weight loss in breastfed newborns. DESIGN: A randomized controlled trial. SETTING: A tertiary perinatal center in a large urban setting. SAMPLE: Women experiencing uncomplicated pregnancies who planned to have epidural analgesia and to breastfeed. METHODS: Healthy pregnant women were randomized to receive an IV epidural preload volume of <500 mLs continuing at an hourly rate of 75-100 mL/h (conservative care) or an epidural preload volume of ≥500 mLs and an hourly rate >125 mL/h (usual care). The primary study outcome was breastfed newborn weight loss >7% prior to hospital discharge. Secondary study outcomes included breastfeeding exclusivity, referral to outpatient breastfeeding clinic support, and delayed discharge. Other outcomes were admission to the neonatal intensive care unit and cord blood pH <7.25. RESULTS: Two hundred women participated (100 in the conservative care and 100 in the usual care groups). Forty-eight of 100 infants in the usual care group and 44 of the 100 infants in the conservative care group lost >7% of their birth weight prior to discharge, p < 0.52 RR 0.92 [0.68-1.24]. CONCLUSION: A policy of restricted IV fluids did not affect newborn weight loss. Women and their care providers should be reassured that the volumes of IV fluid <2500 mLs are unlikely to have a clinically meaningful effect on breastfed newborn weight loss >7%. Exploratory analyses suggest that breastfed newborn weight loss increases when intrapartum volumes infused are >2500 mLs. Care providers are encouraged to consider volumes of IV fluid infused intrapartum as a factor that may have contributed to early newborn weight loss in the first 48 h of life.

The effect of telephone-based interpersonal psychotherapy for the treatment of postpartum depression: study protocol for a randomized controlled trial.

BACKGROUND: Substantial data indicate potential health consequences of untreated postpartum depression (PPD) on the mother, infant, and family. Studies have evaluated interpersonal psychotherapy (IPT) as treatment for PPD; however, the results are questionable due to methodological limitations. A comprehensive review of maternal treatment preferences suggests that mothers favor 'talking therapy' as a form of PPD treatment. Unfortunately, IPT is not widely available, especially in rural and remote areas. To improve access to care, telepsychiatry has been introduced, including the provision of therapy via the telephone. METHODS/DESIGN: The purpose of this randomized controlled trial is to evaluate the effect of telephone-based IPT on the treatment of PPD. Stratification is based on self-reported history of depression and province. The target sample is 240 women. Currently, women from across Canada between 2 and 24 weeks postpartum are able to either self-identify as depressed and refer themselves to the trial or they may be referred by a health professional based on a score >12 on the Edinburgh Postnatal Depression Scale (EPDS). Following contact by the trial coordinator, a detailed study explanation is provided. Women who fulfill the eligibility criteria (including a positive diagnostic assessment for major depression) and consent to participate are randomized to either the control group (standard postpartum care) or intervention group (standard postpartum care plus 12 telephone-based IPT sessions within 12 to 16 weeks, provided by trained nurses). Blinded research nurses telephone participants at 12, 24, and 36 weeks post-randomization to assess for PPD and other outcomes including depressive symptomatology, anxiety, couple adjustment, attachment, and health service utilization. Results from this ongoing trial will: (1) develop the body of knowledge concerning the effect of telephone-based IPT as a treatment option for PPD; (2) advance our understanding of training nurses to deliver IPT; (3) provide an economic evaluation of an IPT intervention; (4) investigate the utility of the EPDS in general clinical practice to identify depressed mothers; and (5) present valuable information regarding PPD, along with associated couple adjustment, co-morbid anxiety and self-reported attachment among a mixed rural and urban Canadian population. TRIAL REGISTRATION: Current Controlled Trials Ltd. ISRCTN88987377.

An all-purpose nipple ointment versus lanolin in treating painful damaged nipples in breastfeeding women: a randomized controlled trial.

BACKGROUND: The negative outcomes associated with painful and damaged nipples have been widely documented in the breastfeeding literature. Numerous studies have been conducted evaluating topical preparations to treat nipple pain and damage with equivocal findings. No studies have evaluated the effectiveness of the increasingly popular all-purpose nipple ointment (APNO). The purpose of this trial is to evaluate the effect of the APNO versus lanolin on nipple pain among breastfeeding women with damaged nipples. SUBJECTS AND METHODS: A double-blind, randomized controlled trial was conducted in a large single-site, tertiary-care hospital in Toronto, ON, Canada. Breastfeeding women (n=151) identified as having damage to one or both nipples were randomized to apply either APNO (intervention group) or lanolin (control group) to their nipples according to the trial protocol. The primary outcome was nipple pain at 1 week after randomization measured using the Short Form McGill Pain Questionnaire. Additional outcomes at 1 week after randomization and 12 weeks postpartum included nipple yeast symptoms and/or mastitis, rates of breastfeeding duration and exclusivity, and maternal satisfaction with infant feeding method and treatment ointment. RESULTS: There were no significant group differences in mean pain scores at 1 week after randomization. Women in the lanolin group reported significantly greater satisfaction with their infant feeding method and had nonsignificantly higher breastfeeding duration and exclusivity rates at 12 weeks postpartum. CONCLUSION: Results suggest that APNO is not superior to lanolin in treating painful, damaged nipples.

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.

Effects of guided imagery on blood pressure in pregnant women with hypertension: a pilot randomized controlled trial.

BACKGROUND: Hypertension occurs in nearly 10 percent of pregnancies, and is associated with higher risk of infant and maternal morbidity and mortality than in normal pregnancies. Previous studies have suggested that relaxation therapies reduce blood pressure in nonpregnant adults. The objectives of this pilot randomized trial were to provide preliminary evidence of whether relaxation by means of guided imagery would reduce blood pressure in hypertensive pregnant women, and to assess the feasibility of a larger trial. METHODS: A total of 69 pregnant women with hypertension were randomized to periods of guided imagery or of quiet rest, twice daily for 4 weeks or until delivery, whichever came first. Daytime ambulatory mean arterial pressure, systolic and diastolic blood pressure, and anxiety were measured weekly for up to 4 weeks. RESULTS: Women allocated to guided imagery had lower mean arterial pressure elevations over time than those allocated to quiet rest (guided imagery: M = 1.58 mmHg, SD = 7.63; quiet rest: M = 5.93 mmHg, SD = 6.55; t = 2.36, p = 0.02). However, when adjusted for baseline mean arterial pressure and gestation, the effect was not significant (p = 0.14). Numbers of women prescribed antihypertensive medication postrandomization were similar (guided imagery: n = 16; quiet rest: n = 13, χ(2) = 0.74, p = 0.46). There was also no evidence of an effect on women's anxiety. Nearly 90 percent (n = 26) of the guided imagery group indicated that they would use it again. CONCLUSIONS: Further rigorous study is warranted to determine effects of guided imagery on maternal blood pressure and perinatal health outcomes.