Journal of Midwifery & Women’s Health
www.jmwh.org
Updates from the Literature Sharon Bond, CNM, PhD RETHINKING OLD PRACTICES: EVIDENCE SUPPORTS WIPING, NOT SUCTIONING, NEWBORN SECRETIONS AT BIRTH
The practice of using a soft bulb or catheter to suction secretions from the newborn after birth in order to clear the airway and stimulate respiration has been a common practice for decades. Within the last several years, this practice has become the subject of studies, reviews, and opinion articles examining its necessity and safety.1–3 Since 2006, the World Health Organization (WHO) has not recommended the use of suction to clear the airway or stimulate respiration unless the newborn is not breathing.4,5 The American Heart Association advises that any suctioning, including the use of a bulb, be reserved only for newborns with an obvious impediment to spontaneous breathing.6 The American Academy of Pediatrics and the American College of Obstetricians and Gynecologists support the American Heart Association’s recommendations.7 Kelleher et al undertook this study in part because the earlier works did not directly compare the outcomes for wiping secretions at birth with the routine use of suctioning. Authors observed that, despite evidence showing that the use of routine suctioning shows no benefit and may produce harm, the practice remains commonplace. After screening more than 2000 women at 35 weeks’ gestation, researchers randomized 506 term newborns to either wiping the nose and mouth at birth with a towel or using a bulb syringe for oronasopharyngeal suction to test their hypothesis that there would be no differences in the respiratory rates between the 2 groups. The mean respiratory rate in the first 24 hours after birth was the primary measured outcome. An earlier study estimated the mean respiratory rate of newborns in the first 24 hours at 50 breaths per minute, and one standard deviation from the mean was estimated at 14 breaths per minute.8 Authors stated that using transient tachypnea as the primary outcome would have required a larger sample size; thus, it was not selected. Secondary outcomes were the use of advanced resuscitation by intubation, positive-pressure ventilation, chest compressions, use of emergency medications, Apgar scores, tachypnea within the first 24 hours, or admission to the neonatal intensive care unit (NICU). Randomization occurred through a computer-generated sequence. Although it was not practical to blind the birth room personnel, the request for specific intervention (wipe vs suction) was sealed in an envelope until birth. High-risk newborns were excluded based on conditions such as known major congenital anomalies, anticipated advanced resuscitation, nonvigorous newborns with meconium-stained amniotic fluid, and those previously enrolled in other studies involving birth room interventions. Women undergoing cesarean births were not excluded un-
less the risk factors described above were also identified. Two one-tailed t tests were used to analyze the primary outcome. Intention-to-treat analyses, including per treatment and per protocol, were used to examine outcomes (Box 1). Baseline characteristics of the 2 groups of women were similar. In the wipe-only arm (n = 246), 30% of women had cesareans and 13% had meconium-stained amniotic fluid. In the suction group (n = 242), 36% had cesareans and 10% had meconium-stained amniotic fluid. Rates for Apgar scores, diabetes, hypertension, and group B streptococcus status were similar between groups. Neonatal respiratory rates showed no differences in the intention-to-treat,9 per-treatment, or perprotocol analyses. Furthermore, secondary outcomes did not differ between groups, including any respiratory rate above 60 breaths per minute in the first 24 hours. More neonates from the wipe group (18%) were admitted to the NICU than from the suction group (12%). This difference was not statistically significant (P = .07), and the study was not adequately powered to measure this outcome. Approximately 10% of newborns require some form of assistance to begin breathing at birth.6 In 1971, a seminal study showed that 15% of newborns could experience arrhythmia and severe bradycardia following nasopharyngeal suctioning.10 This study by Kelleher et al demonstrates that removing secretions by wiping the newborn’s nose and mouth is as effective as suctioning, when assessed by a comparison of respiratory rate within the first 24 hours of birth. The strengths of this study include its large size, adequate power to achieve significance, and randomization design to assess a single outcome. An independent safety-monitoring board reviewed the data, without knowledge of randomization status when recruitment reached 25% and 75%. Authors acknowledge the limitations of their study; primarily deviations from the protocol that occurred at the beginning of the study, most likely because suctioning was the standard practice in the institution at the time. Crossovers from the wipe to the suction group (20%) most likely reflected staff bias that preferred suctioning to wiping; however, despite the crossovers, the pertreatment analysis also found suctioning and wiping to be equivalent. Whereas birth room nurses could not be blinded to the specific intervention assigned to each newborn, nursery nurses recorded respiratory rates and other outcome measures without knowledge of the treatment arm. These findings, along with recommendations from leading maternal health experts and the WHO, support using a towel to wipe secretions from the mouth and nose of newborns. Some studies have identified potential harms of bulb suctioning in otherwise vigorous newborns who spontaneously breathe at birth, including those born through meconium-stained amniotic fluid. Shifting longstanding practices can be challenging. With supportive evidence, midwives can initiate practice change in their respective settings.
220
c 2015 by the American College of Nurse-Midwives
Kelleher J, Bhat R, Salas AA, Addis D, Mills EC, Mallick H, et al. Oronasopharyngeal suction versus wiping of the mouth and nose at birth: a randomised equivalency trial. Lancet. 2013;382(9889):326-330.
1526-9523/09/$36.00 doi:10.1111/jmwh.12301
Box 1. What Is Intention-to-Treat Analysis?9
When conducting clinical trials in the real-world setting, problems with nonadherence to study protocols and missing data often occur despite the best plans. An intentionto-treat (ITT) analysis includes every participant, once randomized, whether or not the participant adhered to the protocol, withdrew from the study, or actually received the intended treatment. The benefit of this method of analysis is that it circumvents an overly optimistic estimate of findings that comes from the removal of participants who, for whatever reason, did not adhere to the protocol, leaving instead only those results from perfectly adherent participants. ITT analysis acknowledges that laboratoryperfect results do not always occur in actual clinical settings and recognizes that less-than-perfect participant adherence more likely reflects what happens in real-world settings. Consequently, with an ITT analysis, a more unbiased estimate of treatment effect is possible.
1.Graves BW, Haley MM. Newborn transition. J Midwifery Womens Health. 2013;58(6):662-670.
2.Raghuveer TS, Cox AJ. Neonatal resuscitation: An update. Am Fam Physician. 2011;83(8):911-918. 3.O’Donnell CP. Turn and face the strange - ch..ch..ch..changes to neonatal resuscitation guidelines in the past decade. J Paediatr Child Health. 2012;48(9):735-739. 4.WHO. Pregnancy, Childbirth, Postpartum and Newborn Care: A Guide for Essential Practice, 2nd ed. Geneva, Switzerland: World Health Organization, 2009. 5.WHO. Guidelines on basic newborn resuscitation. http://www.who.int/ maternal child adolescent/documents/basic newborn resuscitation/ en/. Accessed January 15, 2015. 6.Kattwinkel J, Perlman JM, Aziz K, Colby C, Fairchild K, Gallagher J, et al. Part 15: neonatal resuscitation: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2010;122(suppl 3):S909S919. 7.American Academy of Pediatrics and American College of Obstetricians and Gynecologists. Guidelines for Perinatal Care, 7th ed. Elk Grove, IL: American Academy of Pediatrics. 2012. 8.Morley CJ, Thornton AJ, Fowler MA, Cole TJ, Hewson PH. Respiratory rate and severity of illness in babies under 6 months old. Arch Dis Child. 1990;65(8):834-837. 9.Gupta SK. Intention-to-treat concept: A review. Perspec Clin Res. 2011;2(3): 109-112. 10.Cordero L, Jr., Hon EH. Neonatal bradycardia following nasopharyngeal stimulation. J Pediatrics. 1971;78(3):441-447.
ELECTRONIC ACCESS NOW AVAILABLE FOR UPDATED ADULT IMMUNIZATION SCHEDULES
Centers for Disease Control and Prevention. Adult immunization schedules. United States 2015. http://www.cdc. gov/vaccines/schedules/hcp/adult.html Every year, approximately 226,000 people in the United States are hospitalized with influenza, leading to between 3000 and 49,000 deaths either from influenza or its complications, respectively.1 In 2012, 3300 adults died from pneumococcal illness.1 Each year, the human papillomavirus causes 17,000 cancers in women and 9000 cancers in men.1 Vaccines can help prevent more than 25 illnesses leading to death, disability, and chronic pain. Indeed, vaccination is credited with being one of the 10 greatest public health achievements of the 20th century.2 The Advisory Committee on Immunization Practices convenes to review the recommended adult (aged ⬎ 18 years) vaccination schedules to be certain that these align with current recommendations. With mounting new evidence, an annual review process is essential to maintain safety and currency. Multiple professional organizations, including the American College of Nurse-Midwives, participate in this process and endorse new recommendations. Most of the changes for 2015 concern pneumococcal vaccine recommendations and influenza vaccine contraindications and precautions. With respect to the influenza vaccine, there are currently 3 types available: inactivated, recombinant, and live
attenuated. Because the recombinant influenza does not contain any egg protein, it is indicated for individuals aged 8 to 49 years. The live attenuated influenza vaccine is contraindicated in pregnant women, adults with egg allergy, those with immunosuppression, and any adults who have used influenza antiviral medications (eg, oseltamivir phosphate [Tamiflu]). Furthermore, individuals should avoid the use of influenza antivirals for 14 days following vaccination. These changes are reflected in the footnotes section and in wording changes to the contraindications table. Midwives can download a free app for their mobile device containing the latest and most updated information for child, adolescent, and adult schedules.3 Any changes to the vaccine schedules are directly released through updates to the app. 1.Centers for Disease Control and Prevention. Vaccine-preventable adult diseases. http://www.cdc.gov/vaccines/adults/vpd.html. Accessed January 15, 2015. 2.Centers for Disease Control and Prevention. Ten great public health achievements in the 20th century. http://www.cdc.gov/about/history/ tengpha.htm. Accessed January 15, 2015. 3.Centers for Disease Control and Prevention. CDC vaccine schedules app for clinicians and other immunization providers. http://www.cdc.gov/vaccines/schedules/hcp/schedule-app.html. Accessed January 15, 2015.
AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS RELEASES COMMITTEE OPINION ON ESTIMATION OF DUE DATE
American College of Obstetricians and Gynecologists. Method for estimating due date. Committee opinion no. 611. Obstet Gynecol. 2014;124(4):863-866.
Journal of Midwifery & Women’s Health r www.jmwh.org
The estimated date of birth (EDB) is a critical parameter to establish and improve health outcomes for women and newborns. Arriving at an EDB is the result of accurate history
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taking; physical examination; and in most midwifery and obstetric practices in the United States, the information obtained from ultrasound measurements. An accurate EDB is useful for determining the frequency of prenatal visits, collecting laboratory tests at specific gestational ages, assessing fetal growth parameters, and determining if and when to use interventions to prevent morbidities that occur as a consequence of preterm or postterm birth. Furthermore, gestational age at birth is a key data point on birth certificates and is used by state and national offices of vital statistics. A standardized approach to determining EDB is essential for public health investigations and research, in addition to clinical care. Historically, the EDB has been determined by reviewing the woman’s recollection of the first day of her last menstrual period (LMP), in conjunction with a physical examination, then adding 280 days. This method does not take into account the errors in a woman’s recall, irregularity of menstrual cycles, timing of ovulation, inconsistent use of contraception, inaccuracies in estimation of uterine size, and natural variations in the presence of fetal heart tones and gestational length. Ultrasound measurement has become exceedingly useful for dating pregnancies more precisely, and high-quality ultrasound is widely available in the United States.
In this committee opinion, the American College of Obstetricians and Gynecologists, in conjunction with the American Institute of Ultrasound in Medicine and the Society for Maternal-Fetal Medicine, outline a standardized approach to determining EDB, recognizing that ultrasound measurements are most accurate when obtained within the first 13 6/7 weeks’ gestation based on LMP. With advancing gestational age, discrepancies between ultrasound and LMP dating increase. For example, a discrepancy of more than 5 to 7 days between LMP dating and assessment from the crown-rump length measurement taken in the first 13 6/7 weeks’ gestation supports basing the EDB on the ultrasound measure rather than the LMP. A discrepancy of more than 21 days between the LMP and assessment from ultrasound measurements of biparietal diameter, head and abdominal circumference, and femur length at a gestational age of 28 weeks and later supports basing the EDB on the ultrasound. The document contains a useful table highlighting the guidelines for reassigning the EDB based on ultrasound measures according to the most current evidence and expertise. Midwives will find this opinion a valuable reference, and the guidelines presented in Table 1 are a useful adjunct when reconciling discrepant LMPs and ultrasound measures.
US PREVENTIVE SERVICES TASK FORCE GUIDELINE SUPPORTS LOW-DOSE ASPIRIN FOR PREVENTION OF PREECLAMPSIA
LeFevre M; U.S. Preventive Services Task Force. Low-dose aspirin use for the prevention of morbidity and mortality from preeclampsia: U.S. Preventive Services Task Force recommendation statement. Ann Int Med. 2014;161(11):819-826. Preeclampsia affects approximately 3% to 6% of all pregnancies. Women pregnant for the first time have a 1.5 to 2.0 greater risk for developing preeclampsia than women having subsequent pregnancies, and prevalence of the disease appears to be increasing from 2.5% in 1987 to 3.2% in 2004.1 This apparent increase may be the result of differences in lifestyle factors over time (eg, decrease in smoking rates, increase in obesity rates) or changes in diagnostic criteria.1 Preeclampsia accounts for 15% of all preterm births in the United States.2 This statement from the US Preventive Services Task Force (USPTSF) summarizes the current state of evidence and recommendations for use of low-dose aspirin (81 mg, or 60 mg-150 mg) after 12 weeks’ gestation in women at high risk for preeclampsia. This is presented as a grade B recommendation.2 Women identified as high risk for preeclampsia include those with a history of preeclampsia, especially when accompanied by an untoward outcome; multiple gestation; chronic hypertension; diabetes (type 1 or 2); renal disease; or autoimmune syndromes such as systemic lupus erythematosus or antiphospholipid syndrome. Harms that may result from using low-dose aspirin are considered small in relation to potential benefits. In developing their guideline, the USPTSF examined 15 randomized placebo-controlled trials, rated as good quality, to assess maternal and child health benefits. In brief, pooled findings from 10 studies of women at increased risk
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of preeclampsia taking aspirin (N = 11,779) showed a 14% reduction in risk for preterm birth (relative risk [RR], 0.86; 95% confidence interval [CI], 0.76-0.98; I2 = 33.2%). The reduction in preterm birth resulted from fewer women who developed preeclampsia, in addition to a delay in its development; that is, those women who developed preeclampsia did so at later gestational ages. Furthermore, pooled findings from 13 studies of high-risk women using aspirin (N = 12,184) showed a 24% reduction in risk for preeclampsia (RR, 0.76; 95% CI, 0.62-0.95). In pooled estimates from 13 studies (N = 10,712), newborns whose mothers took aspirin had increased mean birth weight (weighted mean difference, 130.0 g; 95% CI, 36.2-223.3 g; I 2 = 60%). Pooled RR for intracranial hemorrhage in newborns in 6 studies (N = 22,158) was 0.84 (95% CI, 0.61-1.16). It is believed that the antiinflammatory, antiangiogenesis, and antiplatelet properties of aspirin influence the protective benefits against preeclampsia. This guideline updates a previous publication from 1996 stating that there was insufficient evidence to recommend the use of low-dose aspirin to prevent preeclampsia. This guideline generally endorses (with minor differences) previous recommendations from other well-recognized organizations concerned with maternal child health, including the World Health Organization, the American Congress of Obstetricians and Gynecologists, the American Heart Association, the American Academy of Family Physicians, and the National Institute for Health and Care Excellence. By reviewing risk factors for preeclampsia and applying guidelines as recommended, midwives can apply the most updated evidence to inform their practices and improve the health of women and newborns.
Volume 60, No. 2, March/April 2015
1.Ananth CV, Keyes KM, Wapner RJ. Pre-eclampsia rates in the United States, 1980-2010: Age-period-cohort analysis. BMJ. 2013;347: f6564 2.Henderson JT, Whitlock EP, O’Connor E, Senger CA, Thompson JH, Rowland MG. Low-Dose Aspirin for the Prevention of Morbidity and Mortality From Preeclampsia: A Systematic Review for the U.S.
Preventive Services Task Force. Evidence Synthesis no. 112. AHRQ publication no. 14-05027-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2014. 3.U. S. Preventive Services Task Force. Grade definitions. http://www. uspreventiveservicestaskforce.org/Page/Name/grade-definitions. Accessed January 15, 2015.
A SYSTEMATIC APPROACH TO CARING FOR WOMEN WITH PERSISTENT AND RECURRENT VAGINITIS
Nyirjesy P. Management of persistent vaginitis. Obstet Gynecol. 2014;124(6):1135-1146. This clinical expert series describes in detail a systematic approach to caring for women with persistent, chronic, and recurring vaginitis. Nyirjesy presents an extensive description of normal physiologic vaginal discharge and how it compares with features and symptoms of abnormal discharge. A pH-based algorithm guides examiners in diagnosing the most common causes of vaginitis based on infectious versus noninfectious etiologies. The 3 most common types described include vulvovaginal candidiasis, bacterial vaginosis, and trichomoniasis. Of special interest are sections devoted to concerns of older women that produce vaginal symptoms such as vulvovaginal atrophy (genitourinary syndrome of menopause) and desquamative inflammatory vaginitis. An important focus of this work concerns the management of women with recurrent, persistent, and chronically recurring vaginal symptoms. Practices such as telephone prescribing, failure to perform an adequate history, not including
a vaginal pH in the initial assessment, reliance on the Papanicolaou test to identify conditions such as bacterial vaginosis, and failure to follow up are strongly discouraged. Use of yeast (fungal) cultures and other ancillary testing techniques are essential for proper identification of etiology, and therefore, for appropriate treatment. When recurrences develop, Nyirjesy outlines therapy options based on the best available evidence and expert opinion. This work goes beyond the Centers for Disease Control and Prevention’s Sexually Transmitted Disease Guidelines1 particularly with respect to treating difficult cases, recurrent and persistent vaginitis, and noninfectious conditions found in postmenopausal women when the addition of estrogen may or may not be the sole solution. This is an essential read for midwives seeing pregnant, nonpregnant, and postmenopausal women with vaginal symptoms. 1.Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2010. http://www.cdc.gov/std/ treatment/2010/. Accessed January 15, 2015.
DATA FROM 6 HEALTH PLANS IN THE UNITED STATES SHOW ELECTIVE INDUCTIONS ON THE DECLINE
Dublin S, Johnson KE, Walker RL, Avalos LA, Andrade SE, Beaton SJ, et al. Trends in elective labor induction for six United States health plans, 2001-2007. J Womens Health. 2014;23(11):904-911. This is a retrospective cohort study examining trends in elective labor induction from 2001 to 2007 using data from 6 large health plans in the United States. A review of earlier studies showed that rates of labor induction in the United States climbed rapidly from 9% in 1989 to 19% in 1998 to 23% in 1-3 2008. Currently, there is a lack of evidence suggesting that labor induction that was performed for convenience or that did not otherwise meet criteria for an accepted medical indication (such as preeclampsia) improves maternal–child health outcomes. Dublin et al used birth certificate and health plan data to examine 339,123 births at 35 weeks’ gestation or later between 2001 and 2007. Researchers were able to link birth certificate and health plan data to identify information about maternal health, pregnancy complications, and health outcomes. Labor inductions were considered elective if no accepted indication was coded. Acceptable indications for labor induction included documented maternal or obstetric conditions such as gestational age of 41 completed weeks or greater, premature rupture of membranes, gestational hypertension and preeclampsia, diabetes, oligohydramnios, hypertension, intrauterine growth restriction, maternal renal or cardiac disease, abruption, ABO incompatibility, and fetal distress Journal of Midwifery & Women’s Health r www.jmwh.org
before onset of labor. Contraindications to labor induction, as described by the American College of Obstetricians and Gynecologists (eg, multiple gestation, placenta previa, malpresentation), and women with previous cesarean births were identified if documented on the birth certificate or health plan. Percentages were calculated for categorical variables, and means and standard deviations were calculated for continuous variables. Chi-square tests and analyses of variance were used to test for statistical significance. Overall, 100,459 (26%) of the 339,123 births examined were induced. Elective (no acceptable medical indication) labor induction occurred in 11% (95% confidence interval, 10.7%-11.3%). From 2001 to 2005, there was a shift to induction of labor at earlier gestational ages. Overall rates of induction of labor rose from 28.1% in 2001 to 32% in 2005 and then declined to 29.1% in 2007. Among the induced group, 58.9% had documented accepted medical indications, whereas the remaining 41.1% had not. The most common time for elective labor induction to occur was at 40 completed weeks’ gestation, although the largest decline during the study period, from 20.8% to 17.1%, occurred among this group and was most evident in nulliparous women when compared with parous women. Women who had elective labor induction were more likely to be non-Hispanic white. Dublin et al note that only 36% of the elective labor inductions were confirmed on review of medical records. When separated out, the rates of medically indicated labor induction appeared stable over time, whereas the rates for elective labor induction trended over time, 223
peaking in 2005. Furthermore, there were significant variations in rates among the 6 health plans. Authors attribute the trends for rates of elective labor inductions to changes in practice patterns, patient preferences, coding changes, and national and local initiatives. Strengths of this study lie in the inclusion of 6 health plans representing a diverse population, multiple institutions, and varied geographic regions in the United States. The use of health plan data, in addition to birth certificate data, improves accuracy and reliability of findings because birth certificate data are notoriously unreliable.4,5 Authors note that their measure of elective labor induction may have limitations. They cite possible false positives as well as false negatives. Some medically indicated labor inductions may have been inadvertently omitted, and some that were coded as elective may have been medically needed. Several of the health plans transitioned to electronic records during this time period, which may have affected coding practices. Despite the strengths and limitations presented, this study raises questions about the benefits and harms of elective labor induction at term. Previous studies have defined unfavorable neonatal outcomes of elective labor induction before 39 weeks’ gestation, precipitating national campaigns to limit the practice such as the March of Dimes’ Healthy Babies are
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Worth the Wait. Midwives will want to follow trends and practices in elective labor induction and work with hospital committees to evaluate and reduce health consequences. Midwives are model contributors and leaders in state and institutional efforts to decrease elective labor induction rates. 1.Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Matthews TJ, Osterman MJ. Births: Final data for 2008. Natl Vital Stat Rep. 2010;59(1):1,3-71. 2.Zhang J, Yancey MK, Henderson CE. U.S. national trends in labor induction, 1989-1998. J Reprod Med. 2002;47(2):120-124. 3.MacDorman MF, Mathews TJ, Martin JA, Malloy MH. Trends and characteristics of induced labour in the United States, 1989-98. Paediatr Perinat Epidemiol. 2002;16(3):263-273. 4.Grimes D. Epidemiologic research using administrative databases: Garbage in, garbage out. Obstet Gynecol. 2010;116(5):1018-1019. 5.Northam S, Knapp TR. The reliability and validity of birth certificates. JOGNN. 2006;35(1):3–12.
AUTHOR
Sharon Bond, CNM, PhD, FACNM, is in clinical practice at the Medical University of South Carolina Womens’ Health at Cannon Place and a member in the Department of Obstetrics and Gynecology at the Medical University of South Carolina.
Volume 60, No. 2, March/April 2015
www.jmwh.org
Updates from the Literature Sharon Bond, CNM, PhD RETHINKING OLD PRACTICES: EVIDENCE SUPPORTS WIPING, NOT SUCTIONING, NEWBORN SECRETIONS AT BIRTH
The practice of using a soft bulb or catheter to suction secretions from the newborn after birth in order to clear the airway and stimulate respiration has been a common practice for decades. Within the last several years, this practice has become the subject of studies, reviews, and opinion articles examining its necessity and safety.1–3 Since 2006, the World Health Organization (WHO) has not recommended the use of suction to clear the airway or stimulate respiration unless the newborn is not breathing.4,5 The American Heart Association advises that any suctioning, including the use of a bulb, be reserved only for newborns with an obvious impediment to spontaneous breathing.6 The American Academy of Pediatrics and the American College of Obstetricians and Gynecologists support the American Heart Association’s recommendations.7 Kelleher et al undertook this study in part because the earlier works did not directly compare the outcomes for wiping secretions at birth with the routine use of suctioning. Authors observed that, despite evidence showing that the use of routine suctioning shows no benefit and may produce harm, the practice remains commonplace. After screening more than 2000 women at 35 weeks’ gestation, researchers randomized 506 term newborns to either wiping the nose and mouth at birth with a towel or using a bulb syringe for oronasopharyngeal suction to test their hypothesis that there would be no differences in the respiratory rates between the 2 groups. The mean respiratory rate in the first 24 hours after birth was the primary measured outcome. An earlier study estimated the mean respiratory rate of newborns in the first 24 hours at 50 breaths per minute, and one standard deviation from the mean was estimated at 14 breaths per minute.8 Authors stated that using transient tachypnea as the primary outcome would have required a larger sample size; thus, it was not selected. Secondary outcomes were the use of advanced resuscitation by intubation, positive-pressure ventilation, chest compressions, use of emergency medications, Apgar scores, tachypnea within the first 24 hours, or admission to the neonatal intensive care unit (NICU). Randomization occurred through a computer-generated sequence. Although it was not practical to blind the birth room personnel, the request for specific intervention (wipe vs suction) was sealed in an envelope until birth. High-risk newborns were excluded based on conditions such as known major congenital anomalies, anticipated advanced resuscitation, nonvigorous newborns with meconium-stained amniotic fluid, and those previously enrolled in other studies involving birth room interventions. Women undergoing cesarean births were not excluded un-
less the risk factors described above were also identified. Two one-tailed t tests were used to analyze the primary outcome. Intention-to-treat analyses, including per treatment and per protocol, were used to examine outcomes (Box 1). Baseline characteristics of the 2 groups of women were similar. In the wipe-only arm (n = 246), 30% of women had cesareans and 13% had meconium-stained amniotic fluid. In the suction group (n = 242), 36% had cesareans and 10% had meconium-stained amniotic fluid. Rates for Apgar scores, diabetes, hypertension, and group B streptococcus status were similar between groups. Neonatal respiratory rates showed no differences in the intention-to-treat,9 per-treatment, or perprotocol analyses. Furthermore, secondary outcomes did not differ between groups, including any respiratory rate above 60 breaths per minute in the first 24 hours. More neonates from the wipe group (18%) were admitted to the NICU than from the suction group (12%). This difference was not statistically significant (P = .07), and the study was not adequately powered to measure this outcome. Approximately 10% of newborns require some form of assistance to begin breathing at birth.6 In 1971, a seminal study showed that 15% of newborns could experience arrhythmia and severe bradycardia following nasopharyngeal suctioning.10 This study by Kelleher et al demonstrates that removing secretions by wiping the newborn’s nose and mouth is as effective as suctioning, when assessed by a comparison of respiratory rate within the first 24 hours of birth. The strengths of this study include its large size, adequate power to achieve significance, and randomization design to assess a single outcome. An independent safety-monitoring board reviewed the data, without knowledge of randomization status when recruitment reached 25% and 75%. Authors acknowledge the limitations of their study; primarily deviations from the protocol that occurred at the beginning of the study, most likely because suctioning was the standard practice in the institution at the time. Crossovers from the wipe to the suction group (20%) most likely reflected staff bias that preferred suctioning to wiping; however, despite the crossovers, the pertreatment analysis also found suctioning and wiping to be equivalent. Whereas birth room nurses could not be blinded to the specific intervention assigned to each newborn, nursery nurses recorded respiratory rates and other outcome measures without knowledge of the treatment arm. These findings, along with recommendations from leading maternal health experts and the WHO, support using a towel to wipe secretions from the mouth and nose of newborns. Some studies have identified potential harms of bulb suctioning in otherwise vigorous newborns who spontaneously breathe at birth, including those born through meconium-stained amniotic fluid. Shifting longstanding practices can be challenging. With supportive evidence, midwives can initiate practice change in their respective settings.
220
c 2015 by the American College of Nurse-Midwives
Kelleher J, Bhat R, Salas AA, Addis D, Mills EC, Mallick H, et al. Oronasopharyngeal suction versus wiping of the mouth and nose at birth: a randomised equivalency trial. Lancet. 2013;382(9889):326-330.
1526-9523/09/$36.00 doi:10.1111/jmwh.12301
Box 1. What Is Intention-to-Treat Analysis?9
When conducting clinical trials in the real-world setting, problems with nonadherence to study protocols and missing data often occur despite the best plans. An intentionto-treat (ITT) analysis includes every participant, once randomized, whether or not the participant adhered to the protocol, withdrew from the study, or actually received the intended treatment. The benefit of this method of analysis is that it circumvents an overly optimistic estimate of findings that comes from the removal of participants who, for whatever reason, did not adhere to the protocol, leaving instead only those results from perfectly adherent participants. ITT analysis acknowledges that laboratoryperfect results do not always occur in actual clinical settings and recognizes that less-than-perfect participant adherence more likely reflects what happens in real-world settings. Consequently, with an ITT analysis, a more unbiased estimate of treatment effect is possible.
1.Graves BW, Haley MM. Newborn transition. J Midwifery Womens Health. 2013;58(6):662-670.
2.Raghuveer TS, Cox AJ. Neonatal resuscitation: An update. Am Fam Physician. 2011;83(8):911-918. 3.O’Donnell CP. Turn and face the strange - ch..ch..ch..changes to neonatal resuscitation guidelines in the past decade. J Paediatr Child Health. 2012;48(9):735-739. 4.WHO. Pregnancy, Childbirth, Postpartum and Newborn Care: A Guide for Essential Practice, 2nd ed. Geneva, Switzerland: World Health Organization, 2009. 5.WHO. Guidelines on basic newborn resuscitation. http://www.who.int/ maternal child adolescent/documents/basic newborn resuscitation/ en/. Accessed January 15, 2015. 6.Kattwinkel J, Perlman JM, Aziz K, Colby C, Fairchild K, Gallagher J, et al. Part 15: neonatal resuscitation: 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2010;122(suppl 3):S909S919. 7.American Academy of Pediatrics and American College of Obstetricians and Gynecologists. Guidelines for Perinatal Care, 7th ed. Elk Grove, IL: American Academy of Pediatrics. 2012. 8.Morley CJ, Thornton AJ, Fowler MA, Cole TJ, Hewson PH. Respiratory rate and severity of illness in babies under 6 months old. Arch Dis Child. 1990;65(8):834-837. 9.Gupta SK. Intention-to-treat concept: A review. Perspec Clin Res. 2011;2(3): 109-112. 10.Cordero L, Jr., Hon EH. Neonatal bradycardia following nasopharyngeal stimulation. J Pediatrics. 1971;78(3):441-447.
ELECTRONIC ACCESS NOW AVAILABLE FOR UPDATED ADULT IMMUNIZATION SCHEDULES
Centers for Disease Control and Prevention. Adult immunization schedules. United States 2015. http://www.cdc. gov/vaccines/schedules/hcp/adult.html Every year, approximately 226,000 people in the United States are hospitalized with influenza, leading to between 3000 and 49,000 deaths either from influenza or its complications, respectively.1 In 2012, 3300 adults died from pneumococcal illness.1 Each year, the human papillomavirus causes 17,000 cancers in women and 9000 cancers in men.1 Vaccines can help prevent more than 25 illnesses leading to death, disability, and chronic pain. Indeed, vaccination is credited with being one of the 10 greatest public health achievements of the 20th century.2 The Advisory Committee on Immunization Practices convenes to review the recommended adult (aged ⬎ 18 years) vaccination schedules to be certain that these align with current recommendations. With mounting new evidence, an annual review process is essential to maintain safety and currency. Multiple professional organizations, including the American College of Nurse-Midwives, participate in this process and endorse new recommendations. Most of the changes for 2015 concern pneumococcal vaccine recommendations and influenza vaccine contraindications and precautions. With respect to the influenza vaccine, there are currently 3 types available: inactivated, recombinant, and live
attenuated. Because the recombinant influenza does not contain any egg protein, it is indicated for individuals aged 8 to 49 years. The live attenuated influenza vaccine is contraindicated in pregnant women, adults with egg allergy, those with immunosuppression, and any adults who have used influenza antiviral medications (eg, oseltamivir phosphate [Tamiflu]). Furthermore, individuals should avoid the use of influenza antivirals for 14 days following vaccination. These changes are reflected in the footnotes section and in wording changes to the contraindications table. Midwives can download a free app for their mobile device containing the latest and most updated information for child, adolescent, and adult schedules.3 Any changes to the vaccine schedules are directly released through updates to the app. 1.Centers for Disease Control and Prevention. Vaccine-preventable adult diseases. http://www.cdc.gov/vaccines/adults/vpd.html. Accessed January 15, 2015. 2.Centers for Disease Control and Prevention. Ten great public health achievements in the 20th century. http://www.cdc.gov/about/history/ tengpha.htm. Accessed January 15, 2015. 3.Centers for Disease Control and Prevention. CDC vaccine schedules app for clinicians and other immunization providers. http://www.cdc.gov/vaccines/schedules/hcp/schedule-app.html. Accessed January 15, 2015.
AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS RELEASES COMMITTEE OPINION ON ESTIMATION OF DUE DATE
American College of Obstetricians and Gynecologists. Method for estimating due date. Committee opinion no. 611. Obstet Gynecol. 2014;124(4):863-866.
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The estimated date of birth (EDB) is a critical parameter to establish and improve health outcomes for women and newborns. Arriving at an EDB is the result of accurate history
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taking; physical examination; and in most midwifery and obstetric practices in the United States, the information obtained from ultrasound measurements. An accurate EDB is useful for determining the frequency of prenatal visits, collecting laboratory tests at specific gestational ages, assessing fetal growth parameters, and determining if and when to use interventions to prevent morbidities that occur as a consequence of preterm or postterm birth. Furthermore, gestational age at birth is a key data point on birth certificates and is used by state and national offices of vital statistics. A standardized approach to determining EDB is essential for public health investigations and research, in addition to clinical care. Historically, the EDB has been determined by reviewing the woman’s recollection of the first day of her last menstrual period (LMP), in conjunction with a physical examination, then adding 280 days. This method does not take into account the errors in a woman’s recall, irregularity of menstrual cycles, timing of ovulation, inconsistent use of contraception, inaccuracies in estimation of uterine size, and natural variations in the presence of fetal heart tones and gestational length. Ultrasound measurement has become exceedingly useful for dating pregnancies more precisely, and high-quality ultrasound is widely available in the United States.
In this committee opinion, the American College of Obstetricians and Gynecologists, in conjunction with the American Institute of Ultrasound in Medicine and the Society for Maternal-Fetal Medicine, outline a standardized approach to determining EDB, recognizing that ultrasound measurements are most accurate when obtained within the first 13 6/7 weeks’ gestation based on LMP. With advancing gestational age, discrepancies between ultrasound and LMP dating increase. For example, a discrepancy of more than 5 to 7 days between LMP dating and assessment from the crown-rump length measurement taken in the first 13 6/7 weeks’ gestation supports basing the EDB on the ultrasound measure rather than the LMP. A discrepancy of more than 21 days between the LMP and assessment from ultrasound measurements of biparietal diameter, head and abdominal circumference, and femur length at a gestational age of 28 weeks and later supports basing the EDB on the ultrasound. The document contains a useful table highlighting the guidelines for reassigning the EDB based on ultrasound measures according to the most current evidence and expertise. Midwives will find this opinion a valuable reference, and the guidelines presented in Table 1 are a useful adjunct when reconciling discrepant LMPs and ultrasound measures.
US PREVENTIVE SERVICES TASK FORCE GUIDELINE SUPPORTS LOW-DOSE ASPIRIN FOR PREVENTION OF PREECLAMPSIA
LeFevre M; U.S. Preventive Services Task Force. Low-dose aspirin use for the prevention of morbidity and mortality from preeclampsia: U.S. Preventive Services Task Force recommendation statement. Ann Int Med. 2014;161(11):819-826. Preeclampsia affects approximately 3% to 6% of all pregnancies. Women pregnant for the first time have a 1.5 to 2.0 greater risk for developing preeclampsia than women having subsequent pregnancies, and prevalence of the disease appears to be increasing from 2.5% in 1987 to 3.2% in 2004.1 This apparent increase may be the result of differences in lifestyle factors over time (eg, decrease in smoking rates, increase in obesity rates) or changes in diagnostic criteria.1 Preeclampsia accounts for 15% of all preterm births in the United States.2 This statement from the US Preventive Services Task Force (USPTSF) summarizes the current state of evidence and recommendations for use of low-dose aspirin (81 mg, or 60 mg-150 mg) after 12 weeks’ gestation in women at high risk for preeclampsia. This is presented as a grade B recommendation.2 Women identified as high risk for preeclampsia include those with a history of preeclampsia, especially when accompanied by an untoward outcome; multiple gestation; chronic hypertension; diabetes (type 1 or 2); renal disease; or autoimmune syndromes such as systemic lupus erythematosus or antiphospholipid syndrome. Harms that may result from using low-dose aspirin are considered small in relation to potential benefits. In developing their guideline, the USPTSF examined 15 randomized placebo-controlled trials, rated as good quality, to assess maternal and child health benefits. In brief, pooled findings from 10 studies of women at increased risk
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of preeclampsia taking aspirin (N = 11,779) showed a 14% reduction in risk for preterm birth (relative risk [RR], 0.86; 95% confidence interval [CI], 0.76-0.98; I2 = 33.2%). The reduction in preterm birth resulted from fewer women who developed preeclampsia, in addition to a delay in its development; that is, those women who developed preeclampsia did so at later gestational ages. Furthermore, pooled findings from 13 studies of high-risk women using aspirin (N = 12,184) showed a 24% reduction in risk for preeclampsia (RR, 0.76; 95% CI, 0.62-0.95). In pooled estimates from 13 studies (N = 10,712), newborns whose mothers took aspirin had increased mean birth weight (weighted mean difference, 130.0 g; 95% CI, 36.2-223.3 g; I 2 = 60%). Pooled RR for intracranial hemorrhage in newborns in 6 studies (N = 22,158) was 0.84 (95% CI, 0.61-1.16). It is believed that the antiinflammatory, antiangiogenesis, and antiplatelet properties of aspirin influence the protective benefits against preeclampsia. This guideline updates a previous publication from 1996 stating that there was insufficient evidence to recommend the use of low-dose aspirin to prevent preeclampsia. This guideline generally endorses (with minor differences) previous recommendations from other well-recognized organizations concerned with maternal child health, including the World Health Organization, the American Congress of Obstetricians and Gynecologists, the American Heart Association, the American Academy of Family Physicians, and the National Institute for Health and Care Excellence. By reviewing risk factors for preeclampsia and applying guidelines as recommended, midwives can apply the most updated evidence to inform their practices and improve the health of women and newborns.
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1.Ananth CV, Keyes KM, Wapner RJ. Pre-eclampsia rates in the United States, 1980-2010: Age-period-cohort analysis. BMJ. 2013;347: f6564 2.Henderson JT, Whitlock EP, O’Connor E, Senger CA, Thompson JH, Rowland MG. Low-Dose Aspirin for the Prevention of Morbidity and Mortality From Preeclampsia: A Systematic Review for the U.S.
Preventive Services Task Force. Evidence Synthesis no. 112. AHRQ publication no. 14-05027-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2014. 3.U. S. Preventive Services Task Force. Grade definitions. http://www. uspreventiveservicestaskforce.org/Page/Name/grade-definitions. Accessed January 15, 2015.
A SYSTEMATIC APPROACH TO CARING FOR WOMEN WITH PERSISTENT AND RECURRENT VAGINITIS
Nyirjesy P. Management of persistent vaginitis. Obstet Gynecol. 2014;124(6):1135-1146. This clinical expert series describes in detail a systematic approach to caring for women with persistent, chronic, and recurring vaginitis. Nyirjesy presents an extensive description of normal physiologic vaginal discharge and how it compares with features and symptoms of abnormal discharge. A pH-based algorithm guides examiners in diagnosing the most common causes of vaginitis based on infectious versus noninfectious etiologies. The 3 most common types described include vulvovaginal candidiasis, bacterial vaginosis, and trichomoniasis. Of special interest are sections devoted to concerns of older women that produce vaginal symptoms such as vulvovaginal atrophy (genitourinary syndrome of menopause) and desquamative inflammatory vaginitis. An important focus of this work concerns the management of women with recurrent, persistent, and chronically recurring vaginal symptoms. Practices such as telephone prescribing, failure to perform an adequate history, not including
a vaginal pH in the initial assessment, reliance on the Papanicolaou test to identify conditions such as bacterial vaginosis, and failure to follow up are strongly discouraged. Use of yeast (fungal) cultures and other ancillary testing techniques are essential for proper identification of etiology, and therefore, for appropriate treatment. When recurrences develop, Nyirjesy outlines therapy options based on the best available evidence and expert opinion. This work goes beyond the Centers for Disease Control and Prevention’s Sexually Transmitted Disease Guidelines1 particularly with respect to treating difficult cases, recurrent and persistent vaginitis, and noninfectious conditions found in postmenopausal women when the addition of estrogen may or may not be the sole solution. This is an essential read for midwives seeing pregnant, nonpregnant, and postmenopausal women with vaginal symptoms. 1.Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2010. http://www.cdc.gov/std/ treatment/2010/. Accessed January 15, 2015.
DATA FROM 6 HEALTH PLANS IN THE UNITED STATES SHOW ELECTIVE INDUCTIONS ON THE DECLINE
Dublin S, Johnson KE, Walker RL, Avalos LA, Andrade SE, Beaton SJ, et al. Trends in elective labor induction for six United States health plans, 2001-2007. J Womens Health. 2014;23(11):904-911. This is a retrospective cohort study examining trends in elective labor induction from 2001 to 2007 using data from 6 large health plans in the United States. A review of earlier studies showed that rates of labor induction in the United States climbed rapidly from 9% in 1989 to 19% in 1998 to 23% in 1-3 2008. Currently, there is a lack of evidence suggesting that labor induction that was performed for convenience or that did not otherwise meet criteria for an accepted medical indication (such as preeclampsia) improves maternal–child health outcomes. Dublin et al used birth certificate and health plan data to examine 339,123 births at 35 weeks’ gestation or later between 2001 and 2007. Researchers were able to link birth certificate and health plan data to identify information about maternal health, pregnancy complications, and health outcomes. Labor inductions were considered elective if no accepted indication was coded. Acceptable indications for labor induction included documented maternal or obstetric conditions such as gestational age of 41 completed weeks or greater, premature rupture of membranes, gestational hypertension and preeclampsia, diabetes, oligohydramnios, hypertension, intrauterine growth restriction, maternal renal or cardiac disease, abruption, ABO incompatibility, and fetal distress Journal of Midwifery & Women’s Health r www.jmwh.org
before onset of labor. Contraindications to labor induction, as described by the American College of Obstetricians and Gynecologists (eg, multiple gestation, placenta previa, malpresentation), and women with previous cesarean births were identified if documented on the birth certificate or health plan. Percentages were calculated for categorical variables, and means and standard deviations were calculated for continuous variables. Chi-square tests and analyses of variance were used to test for statistical significance. Overall, 100,459 (26%) of the 339,123 births examined were induced. Elective (no acceptable medical indication) labor induction occurred in 11% (95% confidence interval, 10.7%-11.3%). From 2001 to 2005, there was a shift to induction of labor at earlier gestational ages. Overall rates of induction of labor rose from 28.1% in 2001 to 32% in 2005 and then declined to 29.1% in 2007. Among the induced group, 58.9% had documented accepted medical indications, whereas the remaining 41.1% had not. The most common time for elective labor induction to occur was at 40 completed weeks’ gestation, although the largest decline during the study period, from 20.8% to 17.1%, occurred among this group and was most evident in nulliparous women when compared with parous women. Women who had elective labor induction were more likely to be non-Hispanic white. Dublin et al note that only 36% of the elective labor inductions were confirmed on review of medical records. When separated out, the rates of medically indicated labor induction appeared stable over time, whereas the rates for elective labor induction trended over time, 223
peaking in 2005. Furthermore, there were significant variations in rates among the 6 health plans. Authors attribute the trends for rates of elective labor inductions to changes in practice patterns, patient preferences, coding changes, and national and local initiatives. Strengths of this study lie in the inclusion of 6 health plans representing a diverse population, multiple institutions, and varied geographic regions in the United States. The use of health plan data, in addition to birth certificate data, improves accuracy and reliability of findings because birth certificate data are notoriously unreliable.4,5 Authors note that their measure of elective labor induction may have limitations. They cite possible false positives as well as false negatives. Some medically indicated labor inductions may have been inadvertently omitted, and some that were coded as elective may have been medically needed. Several of the health plans transitioned to electronic records during this time period, which may have affected coding practices. Despite the strengths and limitations presented, this study raises questions about the benefits and harms of elective labor induction at term. Previous studies have defined unfavorable neonatal outcomes of elective labor induction before 39 weeks’ gestation, precipitating national campaigns to limit the practice such as the March of Dimes’ Healthy Babies are
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Worth the Wait. Midwives will want to follow trends and practices in elective labor induction and work with hospital committees to evaluate and reduce health consequences. Midwives are model contributors and leaders in state and institutional efforts to decrease elective labor induction rates. 1.Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Matthews TJ, Osterman MJ. Births: Final data for 2008. Natl Vital Stat Rep. 2010;59(1):1,3-71. 2.Zhang J, Yancey MK, Henderson CE. U.S. national trends in labor induction, 1989-1998. J Reprod Med. 2002;47(2):120-124. 3.MacDorman MF, Mathews TJ, Martin JA, Malloy MH. Trends and characteristics of induced labour in the United States, 1989-98. Paediatr Perinat Epidemiol. 2002;16(3):263-273. 4.Grimes D. Epidemiologic research using administrative databases: Garbage in, garbage out. Obstet Gynecol. 2010;116(5):1018-1019. 5.Northam S, Knapp TR. The reliability and validity of birth certificates. JOGNN. 2006;35(1):3–12.
AUTHOR
Sharon Bond, CNM, PhD, FACNM, is in clinical practice at the Medical University of South Carolina Womens’ Health at Cannon Place and a member in the Department of Obstetrics and Gynecology at the Medical University of South Carolina.
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