Midwife-assisted planned home birth: an essential component of improving the safety of childbirth in Sub-Saharan Africa.

Hospital births, when compared to out-of-hospital births, have generally led to not only a significantly reduced maternal and perinatal mortality and morbidity but also an increase in certain interventions. A trend seems to be emerging, especially in the US where some women are requesting home births, which creates ethical challenges for obstetricians and the health care organizations and policy makers. In the developing world, a completely different reality exists. Home births constitute the majority of deliveries in the developing world. There are severe limitations in terms of facilities, health personnel and deeply entrenched cultural and socio-economic conditions militating against hospital births. As a consequence, maternal and perinatal mortality and morbidity remain the highest, especially in Sub-Saharan Africa (SSA). Midwife-assisted planned home birth therefore has a major role to play in increasing the safety of childbirth in SSA. The objective of this paper is to propose a model that can be used to improve the safety of childbirth in low resource countries and to outline why midwife assisted planned home birth with coordination of hospitals is the preferred alternative to unassisted or inadequately assisted planned home birth in SSA.

Effects of hypothermia for perinatal asphyxia on childhood outcomes.

BACKGROUND: In the Total Body Hypothermia for Neonatal Encephalopathy Trial (TOBY), newborns with asphyxial encephalopathy who received hypothermic therapy had improved neurologic outcomes at 18 months of age, but it is uncertain whether such therapy results in longer-term neurocognitive benefits. METHODS: We randomly assigned 325 newborns with asphyxial encephalopathy who were born at a gestational age of 36 weeks or more to receive standard care alone (control) or standard care with hypothermia to a rectal temperature of 33 to 34°C for 72 hours within 6 hours after birth. We evaluated the neurocognitive function of these children at 6 to 7 years of age. The primary outcome of this analysis was the frequency of survival with an IQ score of 85 or higher. RESULTS: A total of 75 of 145 children (52%) in the hypothermia group versus 52 of 132 (39%) in the control group survived with an IQ score of 85 or more (relative risk, 1.31; P=0.04). The proportions of children who died were similar in the hypothermia group and the control group (29% and 30%, respectively). More children in the hypothermia group than in the control group survived without neurologic abnormalities (65 of 145 [45%] vs. 37 of 132 [28%]; relative risk, 1.60; 95% confidence interval, 1.15 to 2.22). Among survivors, children in the hypothermia group, as compared with those in the control group, had significant reductions in the risk of cerebral palsy (21% vs. 36%, P=0.03) and the risk of moderate or severe disability (22% vs. 37%, P=0.03); they also had significantly better motor-function scores. There was no significant between-group difference in parental assessments of children's health status and in results on 10 of 11 psychometric tests. CONCLUSIONS: Moderate hypothermia after perinatal asphyxia resulted in improved neurocognitive outcomes in middle childhood. (Funded by the United Kingdom Medical Research Council and others; TOBY ClinicalTrials.gov number, NCT01092637.).

Perinatal risks of planned home births in the United States.

OBJECTIVE: We analyzed the perinatal risks of midwife-attended planned home births in the United States from 2010 through 2012 and compared them with recommendations from the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) for planned home births. STUDY DESIGN: Data from the US Centers for Disease Control and Prevention's National Center for Health Statistics birth certificate data files from 2010 through 2012 were utilized to analyze the frequency of certain perinatal risk factors that were associated with planned midwife-attended home births in the United States and compare them with deliveries performed in the hospital by certified nurse midwives. Home birth deliveries attended by others were excluded; only planned home births attended by midwives were included. Hospital deliveries attended by certified nurse midwives served as the reference. Perinatal risk factors were those established by ACOG and AAP. RESULTS: Midwife-attended planned home births in the United States had the following risk factors: breech presentation, 0.74% (odds ratio [OR], 3.19; 95% confidence interval [CI], 2.87-3.56); prior cesarean delivery, 4.4% (OR, 2.08; 95% CI, 2.0-2.17); twins, 0.64% (OR, 2.06; 95% CI, 1.84-2.31); and gestational age 41 weeks or longer, 28.19% (OR, 1.71; 95% CI, 1.68-1.74). All 4 perinatal risk factors were significantly higher among midwife-attended planned home births when compared with certified nurse midwives-attended hospital births, and 3 of 4 perinatal risk factors were significantly higher in planned home births attended by non-American Midwifery Certification Board (AMCB)-certified midwives (other midwives) when compared with home births attended by certified nurse midwives. Among midwife-attended planned home births, 65.7% of midwives did not meet the ACOG and AAP recommendations for certification by the American Midwifery Certification Board. CONCLUSION: At least 30% of midwife-attended planned home births are not low risk and not within clinical criteria set by ACOG and AAP, and 65.7% of planned home births in the United States are attended by non-AMCB certified midwives, even though both AAP and ACOG state that only AMCB-certified midwives should attend home births.

Justified skepticism about Apgar scoring in out-of-hospital birth settings.

BACKGROUND: The Apgar score is used worldwide to assess the newborn infant shortly after birth. Apgar scores, including mean scores and those with high cut-off scores, have been used to support claims that planned home birth is as safe as hospital birth. The purpose of this study was to determine the distribution of 5 min Apgar scores among different birth settings and providers in the USA. METHODS: We obtained data from the National Center for Health Statistics of the US Centers for Disease Control birth certificate data for 2007-2010 for all singleton, term births of infants weighing ≥2500 g (n=13,830,531). Patients were then grouped into six categories by birth setting and birth attendant: hospital-based physician, hospital-based midwife, freestanding birth center with either certified nurse midwife and/or other midwife, and home-based delivery with either certified nurse midwife or other midwife. The distribution of each Apgar score from 0 to 10 was assessed for each group. RESULTS: Newborns delivered by other midwives or certified nurse midwives (CNMs) in a birthing center or at home had a significantly higher likelihood of a 5 min maximum Apgar score of 10 than those delivered in a hospital [52.63% in birthing centers, odds ratio (OR) 29.19, 95% confidence interval (CI): 28.29-30.06, and 52.44% at home, OR 28.95, 95% CI: 28.40-29.50; CNMs: 16.43% in birthing centers, OR 5.16, 95% CI: 4.99-5.34, and 36.9% at home births, OR 15.29, 95% CI: 14.85-15.73]. CONCLUSIONS: Our study shows an inexplicable bias of high 5 min Apgar scores of 10 in home or birthing center deliveries. Midwives delivering at home or in birthing centers assigned a significantly higher proportion of Apgar scores of 10 when compared to midwives or physicians delivering in the hospital. Studies that have claimed the safety of out-of-hospital deliveries by using higher mean or high cut-off 5 min Apgar scores and reviews based on these studies should be treated with skepticism by obstetricians and midwives, by pregnant women, and by policy makers. The continued use of studies using higher mean or high cut-off 5 min Apgar scores, and a bias of high Apgar score, to advocate the safety of home births is inappropriate.

Early and total neonatal mortality in relation to birth setting in the United States, 2006-2009.

OBJECTIVE: We examined neonatal mortality in relation to birth settings and birth attendants in the United States from 2006 through 2009. STUDY DESIGN: Data from the Centers for Disease Control and Prevention-linked birth and infant death dataset in the United States from 2006 through 2009 were used to assess early and total neonatal mortality for singleton, vertex, and term births without congenital malformations delivered by midwives and physicians in the hospital and midwives and others out of the hospital. Deliveries by hospital midwives served as the reference. RESULTS: Midwife home births had a significantly higher total neonatal mortality risk than deliveries by hospital midwives (1.26 per 1000 births; relative risk [RR], 3.87 vs 0.32 per 1000; P < .001). Midwife home births of 41 weeks or longer (1.84 per 1000; RR, 6.76 vs 0.27 per 1000; P < .001) and midwife home births of women with a first birth (2.19 per 1000; RR, 6.74 vs 0.33 per 1000; P < .001) had significantly higher risks of total neonatal mortality than deliveries by hospital midwives. In midwife home births, neonatal mortality for first births was twice that of subsequent births (2.19 vs 0.96 per 1000; P < .001). Similar results were observed for early neonatal mortality. The excess total neonatal mortality for midwife home births compared with midwife hospital births was 9.32 per 10,000 births, and the excess early neonatal mortality was 7.89 per 10,000 births. CONCLUSION: Our study shows a significantly increased total and early neonatal mortality for home births and even higher risks for women of 41 weeks or longer and women having a first birth. These significantly increased risks of neonatal mortality in home births must be disclosed by all obstetric practitioners to all pregnant women who express an interest in such births.

The ethics and practice of neonatal resuscitation at the limits of viability: an international perspective.

UNLABELLED: Premature infants at the limits of viability raise difficult ethical, legal, social and economic questions. Neonatologists attending an international Collegium were surveyed about delivery room behaviour, and the approach taken by selected countries practicing 'modern' medicine was explored. CONCLUSION: There were strong preferences for comfort care at 22 weeks and full resuscitation at 24 weeks. Resuscitation was a grey area at 23 weeks. Cultural, social and legal factors also had a considerable impact on decision-making.

Planned home birth: the professional responsibility response.

This article addresses the recrudescence of and new support for midwife-supervised planned home birth in the United States and the other developed countries in the context of professional responsibility. Advocates of planned home birth have emphasized patient safety, patient satisfaction, cost effectiveness, and respect for women's rights. We provide a critical evaluation of each of these claims and identify professionally appropriate responses of obstetricians and other concerned physicians to planned home birth. We start with patient safety and show that planned home birth has unnecessary, preventable, irremediable increased risk of harm for pregnant, fetal, and neonatal patients. We document that the persistently high rates of emergency transport undermines patient safety and satisfaction, the raison d'etre of planned home birth, and that a comprehensive analysis undermines claims about the cost-effectiveness of planned home birth. We then argue that obstetricians and other concerned physicians should understand, identify, and correct the root causes of the recrudescence of planned home birth; respond to expressions of interest in planned home birth by women with evidence-based recommendations against it; refuse to participate in planned home birth; but still provide excellent and compassionate emergency obstetric care to women transported from planned home birth. We explain why obstetricians should not participate in or refer to randomized clinical trials of planned home vs planned hospital birth. We call on obstetricians, other concerned physicians, midwives and other obstetric providers, and their professional associations not to support planned home birth when there are safe and compassionate hospital-based alternatives and to advocate for a safe home-birth-like experience in the hospital.

Apgar score of 0 at 5 minutes and neonatal seizures or serious neurologic dysfunction in relation to birth setting.

OBJECTIVE: To examine the occurrence of 5-minute Apgar scores of 0 and seizures or serious neurologic dysfunction for 4 groups by birth setting and birth attendant (hospital physician, hospital midwife, free-standing birth center midwife, and home midwife) in the United States from 2007-2010. METHODS: Data from the United States Centers for Disease Control's National Center for Health Statistics birth certificate data files were used to assess deliveries by physicians and midwives in and out of the hospital for the 4-year period from 2007-2010 for singleton term births (≥37 weeks' gestation) and ≥2500 g. Five-minute Apgar scores of 0 and neonatal seizures or serious neurologic dysfunction were analyzed for 4 groups by birth setting and birth attendant (hospital physician, hospital midwife, freestanding birth center midwife, and home midwife). RESULTS: Home births (relative risk [RR], 10.55) and births in free-standing birth centers (RR, 3.56) attended by midwives had a significantly higher risk of a 5-minute Apgar score of 0 (P < .0001) than hospital births attended by physicians or midwives. Home births (RR, 3.80) and births in freestanding birth centers attended by midwives (RR, 1.88) had a significantly higher risk of neonatal seizures or serious neurologic dysfunction (P < .0001) than hospital births attended by physicians or midwives. CONCLUSION: The increased risk of 5-minute Apgar score of 0 and seizures or serious neurologic dysfunction of out-of-hospital births should be disclosed by obstetric practitioners to women who express an interest in out-of-hospital birth. Physicians should address patients' motivations for out-of-hospital delivery by continuously improving safe and compassionate care of pregnant, fetal, and neonatal patients in the hospital setting.

Planned home birth in the United States and professionalism: a critical assessment.

Planned home birth has been considered by some to be consistent with professional responsibility in patient care. This article critically assesses the ethical and scientific justification for this view and shows it to be unjustified. We critically assess recent statements by professional associations of obstetricians, one that sanctions and one that endorses planned home birth. We base our critical appraisal on the professional responsibility model of obstetric ethics, which is based on the ethical concept of medicine from the Scottish and English Enlightenments of the 18th century. Our critical assessment supports the following conclusions. Because of its significantly increased, preventable perinatal risks, planned home birth in the United States is not clinically or ethically benign. Attending planned home birth, no matter one's training or experience, is not acting in a professional capacity, because this role preventably results in clinically unnecessary and therefore clinically unacceptable perinatal risk. It is therefore not consistent with the ethical concept of medicine as a profession for any attendant to planned home birth to represent himself or herself as a "professional." Obstetric healthcare associations should neither sanction nor endorse planned home birth. Instead, these associations should recommend against planned home birth. Obstetric healthcare professionals should respond to expressions of interest in planned home birth by pregnant women by informing them that it incurs significantly increased, preventable perinatal risks, by recommending strongly against planned home birth, and by recommending strongly for planned hospital birth. Obstetric healthcare professionals should routinely provide excellent obstetric care to all women transferred to the hospital from a planned home birth.The professional responsibility model of obstetric ethics requires obstetricians to address and remedy legitimate dissatisfaction with some hospital settings and address patients' concerns about excessive interventions. Creating a sustained culture of comprehensive safety, which cannot be achieved in planned home birth, informed by compassionate and respectful treatment of pregnant women, should be a primary focus of professional obstetric responsibility.

Moderate hypothermia to treat perinatal asphyxial encephalopathy.

BACKGROUND: Whether hypothermic therapy improves neurodevelopmental outcomes in newborn infants with asphyxial encephalopathy is uncertain. METHODS: We performed a randomized trial of infants who were less than 6 hours of age and had a gestational age of at least 36 weeks and perinatal asphyxial encephalopathy. We compared intensive care plus cooling of the body to 33.5 degrees C for 72 hours and intensive care alone. The primary outcome was death or severe disability at 18 months of age. Prespecified secondary outcomes included 12 neurologic outcomes and 14 other adverse outcomes. RESULTS: Of 325 infants enrolled, 163 underwent intensive care with cooling, and 162 underwent intensive care alone. In the cooled group, 42 infants died and 32 survived but had severe neurodevelopmental disability, whereas in the noncooled group, 44 infants died and 42 had severe disability (relative risk for either outcome, 0.86; 95% confidence interval [CI], 0.68 to 1.07; P=0.17). Infants in the cooled group had an increased rate of survival without neurologic abnormality (relative risk, 1.57; 95% CI, 1.16 to 2.12; P=0.003). Among survivors, cooling resulted in reduced risks of cerebral palsy (relative risk, 0.67; 95% CI, 0.47 to 0.96; P=0.03) and improved scores on the Mental Developmental Index and Psychomotor Developmental Index of the Bayley Scales of Infant Development II (P=0.03 for each) and the Gross Motor Function Classification System (P=0.01). Improvements in other neurologic outcomes in the cooled group were not significant. Adverse events were mostly minor and not associated with cooling. CONCLUSIONS: Induction of moderate hypothermia for 72 hours in infants who had perinatal asphyxia did not significantly reduce the combined rate of death or severe disability but resulted in improved neurologic outcomes in survivors. (Current Controlled Trials number, ISRCTN89547571.)

Improving obstetric estimation of outcomes of extremely premature neonates: an evolving challenge.

AIMS: A clinically useful website at the US National Institutes of Child Health and Human Development (NICHD) uses an algorithm based on a recent publication to estimate peri-viable neonatal outcomes. This algorithm uses gestational age, ultrasound estimated fetal weight (EFW), fetal sex, and the use of antenatal corticosteroids as the basis for estimation of outcomes and when used after birth is superior to such estimation by gestational age alone. Because one might be tempted to use this algorithm with obstetric patients, we tested its clinical applicability. METHODS: We reviewed the literature using search terms relating to the above clinical factors. Next, we gathered data from the website. The range of outcomes for neonates was then estimated using the uncertainty derived for these clinical factors before birth from the literature review and the NICHD website algorithm. RESULTS: We found increased uncertainty for estimating outcomes, as a function of the greater uncertainty in knowledge of the clinical factors in obstetrics as opposed to neonatology. CONCLUSIONS: The imprecision during the time before birth seriously restricts the obstetric use of the NICHD algorithm at this time. Refining the precision of the algorithm prior to birth is necessary.

Guidelines for the management of postterm pregnancy.

A pregnancy reaching 42 completed weeks (294 days) is defined as postterm (PT). The use of ultrasound in early pregnancy for precise dating significantly reduces the number of PT pregnancies compared to dating based on the last menstrual period. Although the fetal, maternal and neonatal risks increase beyond 41 weeks, there is no conclusive evidence that prolongation of pregnancy, per se, is the major risk factor. Other specific risk factors for adverse outcomes have been identified, the most important of which are restricted fetal growth and fetal malformations. In order to prevent PT and associated complications routine induction before 42 weeks has been proposed. There is no conclusive evidence that this policy improves fetal, maternal and neonatal outcomes as compared to expectant management. It is also unclear if the rate of cesarean sections is different between the two management strategies. After careful identification and exclusion of specific risks, it would seem appropriate to let women make an informed decision about which management they wish to undertake. There is consensus that the number of inductions necessary to possibly avoid one stillbirth is very high. If induction is preferred, procedures for cervical ripening should be used, especially in nulliparous women. Close intrapartum fetal surveillance should be offered, irrespective of whether labor was induced or not.

Ethical dimensions of periviability.

The birth of neonates at the limits of viability, or periviability, poses numerous challenges to health care providers and to systems of care, and the care of these pregnancies and neonates is fraught with ethical controversies. This statement summarizes the ethical principles involved in the care of periviable pregnancies and neonates, and provides expert clinical opinion about the numerous challenges posed by this problem around the world. Topics addressed include a summary of the published experience, an ethical framework, translating neonatal outcome data to the obstetric arena, management as a trial of intervention, referral to tertiary centers, neonatal resuscitation, cesarean delivery for fetal indication, and limits on life-sustaining neonatal treatment.

Therapeutic hypothermia in neonates. Review of current clinical data, ILCOR recommendations and suggestions for implementation in neonatal intensive care units.

Recent evidence suggests that the current ILCOR guidelines regarding hypothermia for the treatment of neonatal encephalopathy need urgent revision. In 2005 when the current ILCOR guidelines were finalised one large (CoolCap trial, n=235) and one small RCT (n=67), in addition to pilot trials, had been published, and demonstrated that therapeutic hypothermia after perinatal asphyxia was safe. The CoolCap trial showed a borderline overall effect on death and disability at 18 months of age, but significant improvement in a large subset of infants with less severe electroencephalographic changes. Based on this and other available evidence, the 2005 ILCOR guidelines supported post-resuscitation hypothermia in paediatric patients after cardiac arrest, but not after neonatal resuscitation. Subsequently, a whole body cooling trial supported by the NICHD reported a significant overall improvement in death or disability. Further large neonatal trials of hypothermia have stopped recruitment and their final results are likely to be published 2009-2011. Many important questions around the optimal therapeutic use of hypothermia remain to be answered. Nevertheless, independent meta-analyses of the published trials now indicate a consistent, robust beneficial effect of therapeutic hypothermia for moderate to severe neonatal encephalopathy, with a mean NNT between 6 and 8. Given that there is currently no other clinically proven treatment for infants with neonatal encephalopathy we propose that an interim advisory statement should be issued to support and guide the introduction of therapeutic hypothermia into routine clinical practice.

The TOBY Study. Whole body hypothermia for the treatment of perinatal asphyxial encephalopathy: a randomised controlled trial.

BACKGROUND: A hypoxic-ischaemic insult occurring around the time of birth may result in an encephalopathic state characterised by the need for resuscitation at birth, neurological depression, seizures and electroencephalographic abnormalities. There is an increasing risk of death or neurodevelopmental abnormalities with more severe encephalopathy. Current management consists of maintaining physiological parameters within the normal range and treating seizures with anticonvulsants. Studies in adult and newborn animals have shown that a reduction of body temperature of 3-4 degrees C after cerebral insults is associated with improved histological and behavioural outcome. Pilot studies in infants with encephalopathy of head cooling combined with mild whole body hypothermia and of moderate whole body cooling to 33.5 degrees C have been reported. No complications were noted but the group sizes were too small to evaluate benefit. METHODS/DESIGN: TOBY is a multi-centre, prospective, randomised study of term infants after perinatal asphyxia comparing those allocated to "intensive care plus total body cooling for 72 hours" with those allocated to "intensive care without cooling".Full-term infants will be randomised within 6 hours of birth to either a control group with the rectal temperature kept at 37 +/- 0.2 degrees C or to whole body cooling, with rectal temperature kept at 33-34 degrees C for 72 hours. Term infants showing signs of moderate or severe encephalopathy +/- seizures have their eligibility confirmed by cerebral function monitoring. Outcomes will be assessed at 18 months of age using neurological and neurodevelopmental testing methods. SAMPLE SIZE: At least 236 infants would be needed to demonstrate a 30% reduction in the relative risk of mortality or serious disability at 18 months. Recruitment was ahead of target by seven months and approvals were obtained allowing recruitment to continue to the end of the planned recruitment phase. 325 infants were recruited. PRIMARY OUTCOME: Combined rate of mortality and severe neurodevelopmental impairment in survivors at 18 months of age. Neurodevelopmental impairment will be defined as any of:* Bayley mental developmental scale score less than 70* Gross Motor Function Classification System Levels III - V* Bilateral cortical visual impairments TRIAL REGISTRATION: Current Controlled Trials ISRCTN89547571.

Neonatal Mortality of Planned Home Birth in the United States in Relation to Professional Certification of Birth Attendants.

INTRODUCTION: Over the last decade, planned home births in the United States (US) have increased, and have been associated with increased neonatal mortality and other morbidities. In a previous study we reported that neonatal mortality is increased in planned home births but we did not perform an analysis for the presence of professional certification status. PURPOSE: The objective of this study therefore was to undertake an analysis to determine whether the professional certification status of midwives or the home birth setting are more closely associated with the increased neonatal mortality of planned midwife-attended home births in the United States. MATERIALS AND METHODS: This study is a secondary analysis of our prior study. The 2006-2009 period linked birth/infant deaths data set was analyzed to examine total neonatal deaths (deaths less than 28 days of life) in term singleton births (37+ weeks and newborn weight ≥ 2,500 grams) without documented congenital malformations by certification status of the midwife: certified nurse midwives (CNM), nurse midwives certified by the American Midwifery Certification Board, and "other" or uncertified midwives who are not certified by the American Midwifery Certification Board. RESULTS: Neonatal mortality rates in hospital births attended by certified midwives were significantly lower (3.2/10,000, RR 0.33 95% CI 0.21-0.53) than home births attended by certified midwives (NNM: 10.0/10,000; RR 1) and uncertified midwives (13.7/10,000; RR 1.41 [95% CI, 0.83-2.38]). The difference in neonatal mortality between certified and uncertified midwives at home births did not reach statistical levels (10.0/10,000 births versus 13.7/10,000 births p = 0.2). CONCLUSIONS: This study confirms that when compared to midwife-attended hospital births, neonatal mortality rates at home births are significantly increased. While NNM was increased in planned homebirths attended by uncertified midwives when compared to certified midwives, this difference was not statistically significant. Neonatal mortality rates at home births were not significantly different in relationship to professional certification status of the birth attendant, whether the delivery was by a certified or an uncertified birth attendant.