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Current Resources for Evidence-Based Practice, November/December 2013 Melissa D. Avery

Correspondence Melissa D. Avery, PhD, CNM, FACNM, FAAN, University of Minnesota, School of Nursing, 5-140 Weaver Densford Hall, 308 Harvard St. SE, Minneapolis, MN 55455. [email protected]

Melissa D. Avery, PhD, CNM, FACNM, FAAN is a professor and Chair of the Child and Family Health Co-operative, University of Minnesota, School of Nursing, Minneapolis, MN.

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ublished simultaneously in the Journal of Midwifery & Women’s Health, 58(6).

Evidence Summary and Research Needed on U.S. Birth Settings On March 6–7, 2013, the Institute of Medicine (IOM) hosted a workshop on research assessing birth settings. The purpose of the meeting was to update the findings from a similar IOM event held in 1982. Experts representing midwifery, nursing, medicine, consumer, and other perspectives presented current evidence related to birth settings, including hospital, hospital-associated and freestanding birth centers, and home. The workshop agenda, speaker slide decks, and recordings of presentations are available online (Institute of Medicine, 2013a). The context within which the 1982 conference was held was similar and different than the 2013 meeting: approximately 1% of U.S. births occurred at home, and three freestanding birth centers in 1975 had increased to 130 in 1982. Rates of induction of labor rose from 8.6% in 1967 to 11.8% in 1977. The cesarean birth rate increased from 7.3% in 1972 to 13.4% in 1977. Physicians attended the majority of births; only 1.6% of births were attended by midwives.

The author report no conflict of interest or relevant financial relationships.

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Information presented at the 2013 workshop included the following data: the cesarean rate was 32.8% in 2011 and appeared to stabilize after two decades of increase. Average gestational age at birth decreased from 40 weeks in 1990 to 39 weeks in 2006; since 2006 the number of births at 37 and 38 weeks decreased whereas the number at 39 and 40 weeks increased. The preterm birth and low-birth-weight rates decreased in recent years. After a decline from 1990 to 2004, out-of-hospital births increased in 2010 to 1.2% of U.S. births. Approximately two thirds of those occurred at home, and nearly one third occurred in birth centers, now numbering more than 250 in

the United States (American Association of Birth Centers, 2013). Midwives now attend the majority of out-of-hospital births and more births in all settings. A higher proportion of births occur to women older than age 30, and the number of women gaining more than 40 pounds during pregnancy has increased. Summaries of the workshop panels included considerations for evaluating studies of birth settings and recommendations for future research. Many of the issues that were described in 1982 were similar to current issues, although more research is now available to guide investigators. Alternative birth settings have been shown to result in the use of fewer interventions. Research was presented showing that the physical environment can affect health outcomes. In reviewing studies of birth settings, it is important to consider possible bias inherent in characteristics of women who choose alternative compared to conventional birth settings. Policies and practices of institutional birth settings and the type and role of care providers are additional considerations that may influence research findings. Common definitions of normal and low risk and other process and outcome measures are needed and will benefit future research. Currently, transfers from home to the hospital setting are not reported, and this information is needed for ongoing research. Although randomized controlled trials can be more difficult in birth setting research, they may be possible in some situations and were recommended for freestanding birth centers and other alternative settings. Longer term outcomes, such as women’s reproductive and gynecologic health and family and childhood outcomes, should be examined as well as shorter term outcomes, such as Apgar score and measures of morbidity and mortality. All states are required to use the new standard birth certificate in 2014, which will help with national-level data collection. System-level information is also needed and includes the best

 C 2013 AWHONN, the Association of Women’s Health, Obstetric and Neonatal Nurses

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configuration of health care teams in birth settings, specifics regarding the role and contributions of nurses, and impact of birth settings on health work force needs. More data are needed related to ideal staffing models in various birth settings as well as the cost of care, which varies considerably by setting and state to state. Medicaid pays for more than 40% of U.S. births and yet does not cover out-of-hospital births in all states and reimbursement level varies by state thus making national data collection difficult. Women’s input regarding care models is important, and more information is needed about how maternity care professionals can best work collaboratively and be educated together to provide excellent care to women and improve outcomes. Finally, improvement of the national vital statistics systems and improved measurement and reporting of perinatal morbidity and mortality are needed. A final report of this meeting is available from the IOM (2013b).

REFERENCES American Association of Birth Centers. (2013). Birth centers in United States. Retrieved from http://www.birthcenters.org/

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Valproate (valproic acid or sodium valproate or a combination of the two) for the prophylaxis of episodic migraine in adults

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legislation/materials

Elective preterm birth for fetal gastroschisis Interconception care for women with a history of gestational diabetes for improving maternal and infant outcomes Intravenous fluids for reducing the duration of labor in low-risk nulliparous women Interventions for supporting pregnant women’s decision making about mode of birth after a caesarean Postpartum misoprostol for preventing maternal mortality and morbidity Posture and fluids for preventing postdural puncture headache Regular (ICSI) versus ultra-high magnification (IMSI) sperm selection for assisted reproduction Telephone support for women during pregnancy and the first 6 weeks postpartum

Institute of Medicine. (2013a). Workshop on research issues in the assessment of birth settings, 2013. Retrieved from http://www.iom.edu/Activities/Women/BirthSettings/2013-MAR06.aspx Institute of Medicine. (2013b). An update on research issues in

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the assessment of birth settings - Workshop summary. Retrieved from http://www.iom.edu/Reports/2013/An-Update-on-

Early versus late administration of amino acids in preterm infants receiving parenteral nutrition

Research-Issues-in-the-Assessment-of-Birth-Settings.aspx

From Cochrane Database of Systematic Reviews (CDSR) ISSUES 6–7, 2013 New Systematic Reviews in CDSR: Women’s Health

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Acupuncture for menopausal hot flashes Acupuncture for stress urinary incontinence in adults Antiepileptics other than gabapentin, pregabalin, topiramate, and valproate for the prophylaxis of episodic migraine in adults Gabapentin or pregabalin for the prophylaxis of episodic migraine in adults Hormone replacement therapy for women with type 1 diabetes mellitus Hormone therapy for sexual function in perimenopausal and postmenopausal women Increased consumption of fruit and vegetables for the primary prevention of cardiovascular diseases Levonorgestrel-releasing intrauterine system for atypical endometrial hyperplasia

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Diet or exercise, or both, for weight reduction in women after childbirth Internet-based interventions for smoking cessation Maintenance chemotherapy for ovarian cancer Progestin-only contraceptives: effects on weight Psychological interventions for women with metastatic breast cancer Screening for breast cancer with mammography Selective serotonin reuptake inhibitors for premenstrual syndrome Weighted vaginal cones for urinary incontinence

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Antispasmodics for labor Antithrombotic therapy for improving maternal or infant health outcomes in women considered at risk of placental dysfunction Castor oil, bath and/or enema for cervical priming and induction of labor Drugs for treatment of very high blood pressure during pregnancy Effect of partogram use on outcomes for women in spontaneous labor at term Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes Enemas during labor High-dose versus low-dose oxytocin for augmentation of delayed labor Intravenous immunoglobulin for preventing infection in preterm and/or low-birth-weight infants Intravenous immunoglobulin for suspected or proven infection in neonates Interventionist versus expectant care for severe pre-eclampsia between 24 and 34 weeks’ gestation Interventions for treating cholestasis in pregnancy Interventions (other than pharmacological, psychosocial, or psychological) for treating antenatal depression Oxytocin augmentation of labor in women with epidural analgesia for reducing operative deliveries Oxytocin versus no treatment or delayed treatment for slow progress in the first stage of spontaneous labor Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth Support for mothers, fathers and families after perinatal death

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Screening for cervical cancer: A systematic review and meta-analysis

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FDG PET-CT for diagnosis of distant metastases in breast cancer patients: a metaanalysis

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Anemia, prenatal iron use, and risk of adverse pregnancy outcomes: Systematic review and meta-analysis Effect of aerobic exercise training on maternal weight gain in pregnancy: A metaanalysis of randomized controlled trials Screening tests for gestational diabetes: A systematic review for the U.S. Preventive Services Task Force

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Effectiveness of probiotics in the prophylaxis of necrotizing enterocolitis in preterm neonates: A systematic review and metaanalysis

Featured Review: Tura, G., Fantahun, M., & Worku, A. (2013). The effect of health facility delivery on neonatal mortality: Systematic review and meta-analysis. BMC Pregnancy & Childbirth, 13, 18. The United Nations Millennium Development Goal (MDG) four is to reduce the rate of mortality for children younger than age 5 by two thirds from 1990 to 2015. Progress has been made, and 1,400 fewer children die each day worldwide. However, nearly seven million children younger than age 5 died in 2011. As the overall rate of mortality for children younger than age 5 has declined, the proportion of deaths to infants one month of age or younger has increased (United Nations, 2013). More than 98% of deaths to children younger than age 5 occur in low and middle income countries, and Sub-Saharan Africa has the highest rate of one in nine. Home birth is common for women of multiple risk levels in many developing countries. Clinicians in developed countries have worked to provide safe home birth options for low-risk women. However, the safety of home birth in the absence of a skilled care provider, particularly in developing countries, has been questioned because place of birth has been associated with outcomes such as neonatal mortality within the first 28 days of life. The purpose of this systematic review and meta-analysis

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was to determine the pooled effect of birth in a health facility compared to home birth on neonatal mortality globally. Randomized controlled trials and observational studies in which researchers examined place of birth and neonatal mortality were included in the analysis. Studies were excluded in which the authors compared planned home birth, including higher risk women, to low-risk women who gave birth at home. The years 1980 to 2012 were included due to the small number of related studies. The review and analysis was conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. A total of 19 studies met criteria for review, and all but one were conducted in middle- and lowincome countries; the remaining study was conducted in Italy. Fourteen of the studies were published within the last 5 years. Research designs included cross sectional, prospective cohort, and community trial. In all, 1,606,805 births were represented. Across all studies examined, neonatal mortality was 11.32 per 1,000 live births. Stratification by place of birth resulted in neonatal mortality rates of 9.32 in a health facility and 32.88 when the birth occurred at home. Overall, a 29% pooled reduction in neonatal mortality was observed when births occurred in health facilities. Heterogeneity among studies was observed, and differences in sample size, study design, and proportion of births in facilities were determined to be the factors responsible.

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mortality rate. Retrieved from http://www.un.org/ millenniumgoals/childhealth.shtml Featured Review: Downe, S., Gyte, G. M. L., Dahlen, H. G., & Singata, M. (2013). Routine vaginal examinations for assessing progress of labour to improve outcomes for women and babies at term. Cochrane Database of Systematic Reviews, 7, CD010088. doi: 10.1002/14651858.CD010088.pub2 Digital vaginal examination (DVE) is commonly used by maternity care clinicians to assess the progress of labor. This assessment is often plotted on a partogram (pictorial view of labor progress) to observe change over time. If deviation from expected normal labor progress is observed, interventions such as transfer to higher level of care or use of techniques to augment labor progress can be instituted to assure safety for mother and newborn. Interventions such as position changes and relaxation techniques may also be used to promote labor progress in an effort to avoid unnecessary interventions such as cesarean birth. Digital vaginal examination for cervical dilation is usually conducted on admission to a labor unit or at onset of labor. Dilation is reassessed at intervals ranging from 2 to 4 hours. Additional determinations include identification of the fetal presenting part and descent and status of amniotic membranes. Accuracy of DVE has been questioned, especially when there are multiple examiners. Although believed to be helpful in assessing labor progress, DVE has also been associated with harms such as infection. Experiencing such an exam can be personally sensitive or embarrassing and uncomfortable for women.

Comment: The authors concluded there is moderate evidence of a 29% reduction in neonatal mortality when births occur in a formal health facility in middle- and low-income countries. The observed effect is higher in countries where the proportion of births in a health facility is higher. This may be because where the rate of health facility births is low, women are more likely to give birth at home and only go to a health facility when a problem occurs. In addition, where birth in facilities is more common, the availability of immunizations for mothers and newborns may prevent some deaths. Longitudinal studies are recommended in areas where evidence regarding the effect of health facility births is not yet available.

This review was conducted to assess the use of DVE for evaluating labor progress to improve maternal and newborn outcomes. Specifically, the authors focused on effectiveness, acceptability, and consequences of DVE. The goal was to compare DVE to no intervention and other interventions such as rectal examination, other mechanical assessments or imaging, the anal cleft (visible purple line associated with venous distention), and maternal behavioral cues. Timing of DVEs was also included. Primary outcomes were duration of labor, maternal and neonatal infection requiring antibiotics, and maternal positive reviews of intrapartum care (composite measure).

United Nations. (2013). Target 4.A: Reduce by two thirds, between 1990 and 2015, the under-five

Criteria for inclusion were randomized controlled trials (RCT) of DVE with or without abdominal

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examination for women at term in spontaneous or induced labor. Studies of partogram as the primary intervention were excluded due to an existing Cochrane Review. Following a comprehensive search, nine reports of seven trials were assessed for eligibility for review. Five trials (six reports) were excluded: in four the authors examined a different intervention, and in one a quasi-RCT format was used. Two trials conducted prior to 1995 were included: in one researchers compared vaginal and rectal examination, and in the other researchers compared 2- and 4-hour intervals of vaginal examination. The main difference between vaginal and rectal examination was that fewer women found the vaginal examination very uncomfortable compared to rectal examination. No differences in primary or secondary outcomes were found in the study comparing 2- and 4-hour vaginal exam intervals for those variables that were measured. Comment: The authors found no randomized controlled trials to support or reject the use of routine DVE to assess labor progress. Concern exists about the harms of obstructed labor and the overdiagnosis of labor dystocia, therefore, an accurate measure is needed. Large-scale trials to establish sensitive and specific methods of assessing labor progress were recommended. A systematic review of observational studies of all measures of maternal labor progress, including a wide diversity of women and birth settings in low-, middle-, and high-income countries was proposed as a next step. Clinicians might evaluate their use of DVE given the lack of evidence to support improvement in outcomes.

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the literature. Pediatric Infectious Disease Journal, 31(11), 1195–1197. van Laerhoven, H., de Haan, T. R., Offringa, M., Post, B., & van der Lee, J. H. (2013). Prognostic tests in term neonates with hypoxicischemic encephalopathy: A systematic review. Pediatrics, 131(1), 88–98. Watts, P., Maguire, S., Kwok, T., Talabani, B., Mann, M., Wiener, J., . . . Kemp, A. (2013). Newborn retinal hemorrhages: A systematic review. Journal of AAPOS, 17(1), 70–78.

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