Analysis of questions by patients with pelvic organ prolapse about vaginal pessaries resulting in a checklist for their physicians.

OBJECTIVE: International guidelines recommend vaginal pessaries as a first-choice treatment of symptomatic pelvic organ prolapse (POP). Gynecologists rarely receive systematic training or just do not take the time to communicate with their patients. We hypothesized that we could identify key deficits and limitations of counseling before or during pessary therapy from questions directed to manufacturers with the aim to improve and promote health literacy of women with POP. METHODS: We approached five manufacturers to provide anonymized inquiries related to pessary use. After exclusion of duplicates and questions about obstetric pessaries, 174 data sets from 145 patients remained. RESULTS: In 19/145 patients (13.1%), a 2nd degree, and in 94/145 (64.8%), a 3rd-4th degree of POP was identified. Four patients had additional urinary incontinence. In 32/145 (22.1%), the severity of POP could not be identified. The age of patients ranged from 27 to 98 (mean = 63.7) years. Most inquiries were related to the selected pessary models or sizes (40/174; 22.9%), self-management (20/174; 11.5%), and technical aspects such as shelf life or appropriate cleaning (26/174; 14.9%). Pain or voiding dysfunction was present in 17/174 remarks (9.7%). Lifestyle questions related to the use of pessaries during sport, menstruation, or mechanical anticonception. The cube pessary was in the focus of interest followed by the sieve bowl, urethra, ring, and Gellhorn device. The list of questions was summarized as a checklist stratified according to priorities. CONCLUSION: The checklist should help improve counseling and self-management of patients to optimize the benefit/risk ratio of conservative treatment of pelvic floor diseases.

Impact of maternal body mass index and gestational weight gain on maternal and neonatal outcomes in twin pregnancies.

INTRODUCTION: To date, there have only been provisional recommendations about the appropriate gestational weight gain in twin pregnancies. This study aimed to contribute evidence to this gap of knowledge. MATERIAL AND METHODS: Using a cohort of 10 603 twin pregnancies delivered between 2000 and 2015 in the state of Hessen, Germany, the individual and combined impact of maternal body mass index and gestational weight gain on maternal and neonatal outcomes was analyzed using uni- and multivariable logistic regression models. The analysis used newly defined population-based quartiles of gestational weight gain in women carrying twin pregnancies (Q1: <419.4 g/week [low weight gain], Q2-Q3: 419.4-692.3 g/week [optimal weight gain], Q4: >692.3 g/week [high weight gain]) and the World Health Organization body mass index classification. RESULTS: Pre-pregnancy body mass index ≥25 kg/m2 was associated with significantly increased rates of cesarean deliveries (aOR1.2, 95% CI: 1.01-1.41) and pregnancy-induced hypertensive disorders (aOR 1.53, 95% CI: 1.11-2.1) but not with any adverse neonatal outcome. Perinatal mortality (aOR 2.23, 95% CI: 1.38-3.6), preterm birth (aOR 1.88, 95% CI: 1.58-2.25), APGAR'5 < 7 (aOR 1.61, 95% CI: 1.19-2.17) and admissions to the neonatal intensive care unit (aOR 1.6, CI: 1.38-1.85) were increased among women with low gestational weight gain. Rates of cesarean deliveries were high in both women with low (aOR 1.25, 95% CI: 1.05-1.48) and high gestational weight gain (aOR 1.17, 95% CI: 1.01-1.35). A high gestational weight gain was also associated with higher rates of hypertensive disorders in pregnancy (aOR 2.32, 95% CI: 1.79-3.02) and postpartum hemorrhage (aOR 1.72, 95%CI: 1.12-2.63). The risk of preterm birth, low Apgar scores and NICU admissions showed a converse linear relation with pre-pregnancy body mass index in women with low gestational weight gain. CONCLUSIONS: In twin pregnancies, nonoptimal weekly maternal weight gain seems to be strongly associated with maternal and neonatal adverse outcomes. Since gestational weight gain is a modifiable risk factor, health care providers have the opportunity to counsel pregnant women with twins and target their care accordingly. Additional research to confirm the validity and generalizability of our findings in different populations is warranted.

Awareness of maternal stress, consequences for the offspring and the need for early interventions to increase stress resilience.

Experimental and clinical studies suggest that prenatal experiences may influence health trajectories up to adulthood and high age. According to the hypothesis of developmental origins of health and disease exposure of pregnant women to stress, nutritional challenges, infection, violence, or war may "program" risks for diseases in later life. Stress and anxieties can exist or be provoked in parents after fertility treatment, after information or diagnosis of fetal abnormalities and demand simultaneous caring concepts to support the parents. In vulnerable groups, it is therefore important to increase the stress resilience to avoid harmful consequences for the growing child. "Enriched environment" defines a key paradigm to decipher how interactions between genes and environment change the structure and function of the brain. The regulation of the fetal hippocampal neurogenesis and morphology during pregnancy is one example of this complex interaction. Animal experiments have demonstrated that an enriched environment can revert consequences of stress in the offspring during critical periods of brain plasticity. Epigenetic markers of stress or wellbeing during pregnancy might even be diagnosed by fragments of placental DNA in the maternal circulation that show characteristic methylation patterns. The development of fetal senses further illustrates how external stimulation may impact individual preferences. Here, we therefore not only discuss how maternal stress influences cognitive development and resilience, but also design possibilities of non-invasive interventions for both mothers and children summarized and evaluated in the light of their potential to improve the health of future generations.

Challenges for better care based on the course of maternal body mass index, weight gain and multiple outcome in twin pregnancies: a population-based retrospective cohort study in Hessen/Germany within 15 years.

INTRODUCTION: Studies on maternal weight, gestational weight gain and associated outcomes in twin pregnancies are scarce. Therefore, we analyzed these items in a large cohort. METHODS: Data from 10,603/13,725 total twin pregnancies from the perinatal database in Hessen, Germany between 2000 and 2015 were used after exclusion of incomplete or non-plausible data sets. The course of maternal and perinatal outcomes was evaluated by linear and logistic regression models. RESULTS: The rate of twin pregnancies increased from 1.5 to 1.9% (p < 0.00001). Mean maternal age and pre-pregnancy weight rose from 31.4 to 32.9 years and from 68.2 to 71.2 kg, respectively (p < 0.001). The rates of women with a body mass index ≥ 30 kg/m2 increased from 11.9 to 16.9% with a mean of 24.4-25.4 kg/m2 (p < 0.001). The overall increase of maternal weight/week was 568 g, the 25th quartile was 419, the 75th quartile 692 g/week. The total and secondary caesareans increased from 68.6 to 73.3% and from 20.6 to 39.8%, respectively (p < 0.001). Rates of birthweight < 1500 g and of preterm birth < 28 and from 28 to 33 + 6 weeks all increased (p < 0.01). No significant changes were observed in the rates of stillbirth, perinatal mortality and NICU admissions. CONCLUSION: The global trend of the obesity epidemic is equally observed in German twin pregnancies. The increase of mean maternal weight and the calculated quartiles specific for twin pregnancies help to identify inadequate weight gain in twin gestations. Policy makers should be aware of future health risks specified for singleton and twin gestations.

Critical appraisal of the proposed defenses for planned home birth.

Two prominent proposed defenses have been offered of planned home birth. The first focuses on the very low absolute risk of planned home birth, which is considered to be safe because it is so low, irrespective of its significantly elevated relative risk. The second invokes an analogy between trial of labor after cesarean delivery and planned home birth. Because trial of labor after cesarean delivery and planned home birth have similar, very low absolute risks and because the former is an acceptable clinical practice, defenders of planned home birth argue that the latter should be considered acceptable. This article presents a critical appraisal of these 2 proposed defenses of planned home birth. Question 1: Are proposed defenses of planned home birth focused on its low absolute risks consistent with the commitment to patient safety? This commitment to patient safety requires the identification of variation in the processes of patient care and reduction of variation when reduction improves outcomes. Relative, as well as absolute, risks therefore must be identified. Compared with hospital midwives, planned home births have a significantly higher relative total neonatal mortality risk of 3.87 (1.26 vs 0.32 per 1000 births; P<.001) and a significantly higher relative risk of 5-minute Apgar score of zero of 18.11 (1.63 vs 0.0/1000 births; P<.001). Planned hospital birth prevents these risks. It follows that planned home birth as a variant in birth setting is not consistent with the commitment to patient safety. Question 2: Is the analogy to trial of labor after cesarean delivery consistent with the philosophic rules of analogic reasoning? The long-established philosophic rules for analogic reasoning require that the 2 cases that are compared are similar in all relevant respects and that all relevant analogies have been considered. The 2 cases are dissimilar because the perinatal risks of planned home births are approximately 3 times higher than trial of labor after cesarean delivery. At least 8 clinical analogies to other situations of very low absolute, but unacceptable, risks are ignored. The clinical implication of the results of this critical appraisal is that obstetricians should respond to expressions of interest in planned home birth based on these proposed defenses with a respectful explanation of the inadequacies, the failure to commit to patient safety, and a recommendation for planned hospital birth.

Prevention of spontaneous preterm birth.

BACKGROUND: It is estimated that globally, approximately 13 million preterm infants are born annually and a much higher number of pregnancies are characterized by threatening preterm birth. FINDINGS: A proportional inverse correlation between gestational age at delivery and neonatal mortality has been observed which is more prevalent in countries without high standard neonatal care. The socioeconomic burden of preterm birth is enormous, as preterm neonates are particularly prone to severe morbidity that may expand up to adulthood. Several strategies have been proposed for the prevention of preterm birth which can be sub-stratified as primary (when these apply to the general population), secondary (when they target women at risk), and tertiary (optimizing neonatal outcomes when preterm birth cannot any longer be prevented). The aim of this review is to summarize the most important strategies.

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.

Is middle cerebral artery Doppler related to neonatal and 2-year infant outcome in early fetal growth restriction?

BACKGROUND: Reduced fetal middle cerebral artery Doppler impedance is associated with hypoxemia in fetal growth restriction. It remains unclear as to whether this finding could be useful in timing delivery, especially in the third trimester. In this regard there is a paucity of evidence from prospective studies. OBJECTIVES: The aim of this study was to determine whether there is an association between middle cerebral artery Doppler impedance and its ratio with the umbilical artery in relation to neonatal and 2 year infant outcome in early fetal growth restriction (26+0-31+6 weeks of gestation). Additionally we sought to explore which ratio is more informative for clinical use. STUDY DESIGN: This is a secondary analysis from the Trial of Randomized Umbilical and Fetal Flow in Europe, a prospective, multicenter, randomized management study on different antenatal monitoring strategies (ductus venosus Doppler changes and computerized cardiotocography short-term variation) in fetal growth restriction diagnosed between 26+0 and 31+6 weeks. We analyzed women with middle cerebral artery Doppler measurement at study entry and within 1 week before delivery and with complete postnatal follow-up (374 of 503). The primary outcome was survival without neurodevelopmental impairment at 2 years corrected for prematurity. Neonatal outcome was defined as survival until first discharge home without severe neonatal morbidity. Z-scores were calculated for middle cerebral artery pulsatility index and both umbilicocerebral and cerebroplacental ratios. Odds ratios of Doppler parameter Z-scores for neonatal and 2 year infant outcome were calculated by multivariable logistic regression analysis adjusted for gestational age and birthweight p50 ratio. RESULTS: Higher middle cerebral artery pulsatility index at inclusion but not within 1 week before delivery was associated with neonatal survival without severe morbidity (odds ratio, 1.24; 95% confidence interval, 1.02-1.52). Middle cerebral artery pulsatility index Z-score and umbilicocerebral ratio Z-score at inclusion were associated with 2 year survival with normal neurodevelopmental outcome (odds ratio, 1.33; 95% confidence interval, 1.03-1.72, and odds ratio, 0.88; 95% confidence interval, 0.78-0.99, respectively) as were gestation at delivery and birthweight p50 ratio (odds ratio, 1.41; 95% confidence interval, 1.20-1.66, and odds ratio, 1.86; 95% confidence interval, 1.33-2.60, respectively). When comparing cerebroplacental ratio against umbilicocerebral ratio, the incremental range of the cerebroplacental ratio tended toward zero, whereas the umbilicocerebral ratio tended toward infinity as the values became more abnormal. CONCLUSION: In a monitoring protocol based on ductus venosus and cardiotocography in early fetal growth restriction (26+0-31+6 weeks of gestation), the impact of middle cerebral artery Doppler and its ratios on outcome is modest and less marked than birthweight and delivery gestation. It is unlikely that middle cerebral artery Doppler and its ratios are informative in optimizing the timing of delivery in fetal growth restriction before 32 weeks of gestation. The umbilicocerebral ratio allows for a better differentiation in the abnormal range than the cerebroplacental ratio.

Planned home births: the need for additional contraindications.

BACKGROUND: Planned home births in the United States are associated with fewer interventions but with increased adverse neonatal outcomes such as perinatal and neonatal deaths, neonatal seizures or serious neurologic dysfunction, and low 5-minute Apgar scores. The American College of Obstetricians and Gynecologists' Committee on Obstetric Practice states that, to reduce perinatal death and to improve outcomes at planned home births, strict criteria are necessary to guide the selection of appropriate candidates for planned home birth. The committee lists 3 absolute contraindications for a planned home birth: fetal malpresentation, multiple gestations, and a history of cesarean delivery. OBJECTIVE: The aim of this study was to evaluate whether there are risk factors that should be considered contraindications to planned home births in addition to the 3 that are listed by the American College of Obstetricians and Gynecologists. STUDY DESIGN: We conducted a population-based, retrospective cohort study of all term (≥37 weeks gestation), normal weight (≥2500 grams), singleton, nonanomalous births from 2009-2013 using the Centers for Disease Control and Prevention's period-linked birth-infant death files that allowed for identification of intended and unintended home births. We examined neonatal deaths (days 0-27 after birth) across 3 groups (hospital-attended births by certified nurse midwives, hospital-attended births by physicians, and planned home births) for 5 risk factors: 2 of the 3 absolute contraindications to home birth listed by the American College of Obstetricians and Gynecologists (breech presentation and previous cesarean delivery) and 3 additional risk factors (parity [nulliparous and multiparous], maternal age [women <35 and ≥35 years old], and gestational age at delivery [37-40 and ≥41 weeks]). RESULTS: The overall risk of neonatal death was significantly higher in planned home births (12.1 neonatal death/10,000 deliveries; P<.001) compared with hospital births by certified nurse midwives (3.08 neonatal death/10,000 deliveries) or physicians (5.09 neonatal death/10,000 deliveries). Neonatal mortality rates were increased significantly at planned home births, with the following individual risk factors: breech presentation (neonatal mortality rate, 127.52/10.000 births), nulliparous pregnant women (neonatal mortality rate, 22.5/10,000), previous cesarean delivery (18.91/10,000 births), and a gestational age ≥41 weeks (neonatal mortality rate, 17.17/10,000 births). Planned home births with ≥1 of the 5 risk factors had significantly higher neonatal death risks compared with deliveries with none of the risks. Neonatal death risk was further increased when a woman's age of ≥35 years was combined with either a first-time birth or a gestational age of ≥41 weeks. CONCLUSIONS: In this study, we show 2 risk factors with significantly increased neonatal mortality rates at planned home births in addition to the 3 factors that are listed by the American College of Obstetricians and Gynecologists. These additional risks factors have neonatal mortality rates that are approaching or exceeding those for planned home birth after cesarean delivery: first-time births and a gestational age of ≥ 41 weeks. Therefore, 2 additional risk factors (first-time births and a gestational age of ≥41 weeks) should be added to the 3 absolute contraindications of planned home births that are listed by the American College of Obstetricians and Gynecologists (previous cesarean delivery, malpresentation, multiple gestations) for a total of 5 contraindications for planned home births.

Underlying causes of neonatal deaths in term singleton pregnancies: home births versus hospital births in the United States.

INTRODUCTION: The objective of this study was to evaluate the underlying causes of neonatal mortality (NNM) in midwife-attended home births and compare them to hospital births attended by a midwife or a physician in the United States (US). METHODS: A retrospective cohort study of the Centers for Disease Control (CDC) linked birth/infant death data set (linked files) for 2008 through 2012 of singleton, term (≥37 weeks) births and normal newborn weights (≥2500 grams). RESULTS: Midwife-attended home births had the highest rate of neonatal deaths [122/95,657 neonatal mortality (NNM) 12.75/10,000; relative risk (RR): 3.6, 95% confidence interval (CI) 3-4.4], followed by hospital physician births (8695/14,447,355 NNM 6.02/10,000; RR: 1.7 95% CI 1.6-1.9) and hospital midwife births (480/1,363,199 NNM 3.52/10,000 RR: 1). Among midwife-assisted home births, underlying causes attributed to labor and delivery caused 39.3% (48/122) of neonatal deaths (RR: 13.4; 95% CI 9-19.9) followed by 29.5% due to congenital anomalies (RR: 2.5; 95% CI 1.8-3.6), and 12.3% due to infections (RR: 4.5; 95% CI 2.5-8.1). COMMENT: There are significantly increased risks of neonatal deaths among midwife-attended home births associated with three underlying causes: labor and delivery issues, infections, and fetal malformations. This analysis of the causes of neonatal death in planned home birth shows that it is consistently riskier for newborns to deliver at home than at the hospital. Physicians, midwives, and other health care providers have a professional responsibility to share information about the clinical benefits and risks of clinical management.

2 year neurodevelopmental and intermediate perinatal outcomes in infants with very preterm fetal growth restriction (TRUFFLE): a randomised trial.

BACKGROUND: No consensus exists for the best way to monitor and when to trigger delivery in mothers of babies with fetal growth restriction. We aimed to assess whether changes in the fetal ductus venosus Doppler waveform (DV) could be used as indications for delivery instead of cardiotocography short-term variation (STV). METHODS: In this prospective, European multicentre, unblinded, randomised study, we included women with singleton fetuses at 26-32 weeks of gestation who had very preterm fetal growth restriction (ie, low abdominal circumference [<10th percentile] and a high umbilical artery Doppler pulsatility index [>95th percentile]). We randomly allocated women 1:1:1, with randomly sized blocks and stratified by participating centre and gestational age (<29 weeks vs ≥29 weeks), to three timing of delivery plans, which differed according to antenatal monitoring strategies: reduced cardiotocograph fetal heart rate STV (CTG STV), early DV changes (pulsatility index >95th percentile; DV p95), or late DV changes (A wave [the deflection within the venous waveform signifying atrial contraction] at or below baseline; DV no A). The primary outcome was survival without cerebral palsy or neurosensory impairment, or a Bayley III developmental score of less than 85, at 2 years of age. We assessed outcomes in surviving infants with known outcomes at 2 years. We did an intention to treat study for all participants for whom we had data. Safety outcomes were deaths in utero and neonatal deaths and were assessed in all randomly allocated women. This study is registered with ISRCTN, number 56204499. FINDINGS: Between Jan 1, 2005 and Oct 1, 2010, 503 of 542 eligible women were randomly allocated to monitoring groups (166 to CTG STV, 167 to DV p95, and 170 to DV no A). The median gestational age at delivery was 30·7 weeks (IQR 29·1-32·1) and mean birthweight was 1019 g (SD 322). The proportion of infants surviving without neuroimpairment did not differ between the CTG STV (111 [77%] of 144 infants with known outcome), DV p95 (119 [84%] of 142), and DV no A (133 [85%] of 157) groups (ptrend=0·09). 12 fetuses (2%) died in utero and 27 (6%) neonatal deaths occurred. Of survivors, more infants where women were randomly assigned to delivery according to late ductus changes (133 [95%] of 140, 95%, 95% CI 90-98) were free of neuroimpairment when compared with those randomly assigned to CTG (111 [85%] of 131, 95% CI 78-90; p=0.005), but this was accompanied by a non-significant increase in perinatal and infant mortality. INTERPRETATION: Although the difference in the proportion of infants surviving without neuroimpairment was non-significant at the primary endpoint, timing of delivery based on the study protocol using late changes in the DV waveform might produce an improvement in developmental outcomes at 2 years of age. FUNDING: ZonMw, The Netherlands and Dr Hans Ludwig Geisenhofer Foundation, Germany.

Vaginal progesterone combined with cervical pessary: A chance for pregnancies at risk for preterm birth?

BACKGROUND: Precocious cervical ripening, as defined by cervical shortening on transvaginal sonography, has prompted a broad evaluation of secondary strategies (such as cerclage, vaginal progesterone, or a cervical pessary) to prevent preterm delivery. However, there is still a lack of direct comparisons between individual treatments or their combinations. OBJECTIVE: We sought to compare at-risk patients and screening patients who had been treated with cervical pessary alone with patients who had been treated with pessary plus vaginal progesterone. STUDY DESIGN: This is a pre- and postintervention cohort study from a preterm labor clinic where placement of a cervical pessary has been the standard treatment since 2008 for at-risk women defined by (1) a history of spontaneous preterm birth at <37 weeks of gestation, (2) conization, or (3) a cerclage because of a previous short cervical length of <3rd percentile and, additionally, with a cervical length of <10th percentile in the ongoing pregnancy. Patients who did not meet the criteria for the "at risk" group, but who had a cervical length of <3rd percentile comprised the screening group. From July 2011 onward, vaginal progesterone (200 mg, suppositories) was prescribed in addition to the pessary. Both at-risk patients (n = 55) and screening patients (n = 51) were treated at the time of diagnosis. The primary outcome was the rate of preterm deliveries at <34 weeks of gestation. Secondary outcomes included deliveries at <28, <32, and <37 weeks of gestation, the days from start of therapy until delivery, a composite index of neonatal outcome, and the number of days in the neonatal intensive care unit. Primary and secondary outcomes were compared between groups with the use of multivariable models to adjust for possible confounders. RESULTS: Delivery at <34 weeks of gestation occurred in 17 of 53 patients (32.1%) who were treated with pessary plus progesterone, compared with 13 of 53 patients (24.5%) who were treated with pessary alone (P = .57). Similarly, there was no difference in the rate of preterm delivery at <28, <32, or <37 weeks of gestation. The composite poor neonatal outcome was 15.1% in the pessary group vs 18.9% in the combined group (P = .96). The mean duration of stay in the neonatal intensive care unit was 46.5 days (range, 9-130 days) in the combined vs 52.0 days (range, 3-151 days) in the pessary group (P < .001). CONCLUSION: In this cohort study, treatment of precocious cervical ripening with cervical pessary plus vaginal progesterone did not reduce the rates of preterm delivery at <28, <32, <34, or <37 weeks of gestation compared with pessary alone. The neonatal intensive care use was shorter in patients who received additional vaginal progesterone, although there was no difference in composite poor neonatal outcome. These preliminary results may serve as a pilot for future trials and provide a basis for treatment until larger trials are completed.

Phase-rectified signal averaging method to predict perinatal outcome in infants with very preterm fetal growth restriction- a secondary analysis of TRUFFLE-trial.

BACKGROUND: Phase-rectified signal averaging, an innovative signal processing technique, can be used to investigate quasi-periodic oscillations in noisy, nonstationary signals that are obtained from fetal heart rate. Phase-rectified signal averaging is currently the best method to predict survival after myocardial infarction in adult cardiology. Application of this method to fetal medicine has established significantly better identification than with short-term variation by computerized cardiotocography of growth-restricted fetuses. OBJECTIVE: The aim of this study was to determine the longitudinal progression of phase-rectified signal averaging indices in severely growth-restricted human fetuses and the prognostic accuracy of the technique in relation to perinatal and neurologic outcome. STUDY DESIGN: Raw data from cardiotocography monitoring of 279 human fetuses were obtained from 8 centers that took part in the multicenter European "TRUFFLE" trial on optimal timing of delivery in fetal growth restriction. Average acceleration and deceleration capacities were calculated by phase-rectified signal averaging to establish progression from 5 days to 1 day before delivery and were compared with short-term variation progression. The receiver operating characteristic curves of average acceleration and deceleration capacities and short-term variation were calculated and compared between techniques for short- and intermediate-term outcome. RESULTS: Average acceleration and deceleration capacities and short-term variation showed a progressive decrease in their diagnostic indices of fetal health from the first examination 5 days before delivery to 1 day before delivery. However, this decrease was significant 3 days before delivery for average acceleration and deceleration capacities, but 2 days before delivery for short-term variation. Compared with analysis of changes in short-term variation, analysis of (delta) average acceleration and deceleration capacities better predicted values of Apgar scores <7 and antenatal death (area under the curve for prediction of antenatal death: delta average acceleration capacity, 0.62 [confidence interval, 0.19-1.0]; delta short-term variation, 0.54 [confidence interval, 0.13-0.97]; P=.006; area under the curve for prediction Apgar <7: average deceleration capacity <24 hours before delivery, 0.64 [confidence interval, 0.52-0.76]; short-term variation <24 hours before delivery, 0.53 [confidence interval, 0.40-0.65]; P=.015). Neither phase-rectified signal averaging indices nor short-term variation showed predictive power for developmental disability at 2 years of age (Bayley developmental quotient, <95 or <85). CONCLUSION: The phase-rectified signal averaging method seems to be at least as good as short-term variation to monitor progressive deterioration of severely growth-restricted fetuses. Our findings suggest that for short-term outcomes such as Apgar score, phase-rectified signal averaging indices could be an even better test than short-term variation. Overall, our findings confirm the possible value of prospective trials based on phase-rectified signal averaging indices of autonomic nervous system of severely growth-restricted fetuses.

Music devices for the fetus? An evaluation of pregnancy music belts.

BACKGROUND: The implementation of music during pregnancy is a topic of interest for parents-to-be accompanied by a growing commercial interest. We evaluated acoustic properties of commercially available music devices. MATERIALS AND METHODS: Sound characteristics of three different music devices designed for fetal acoustical stimulation were analyzed. A white noise sample was presented at a high volume to produce a standardized acoustic stimulus. Sound emissions were registered for each loudspeaker with a sound level meter in order to document the sound pressure levels (SPLs) and to analyze the long-term averaged spectra (LTAS) with the help of PRAAT-sound-analyzing software. Measurements were conducted in open air and under attenuated conditions with interposition of a pork uterus of 5 mm thickness covered by porcine tissue from the abdominal wall of either 3 or 5 cm thickness. RESULTS: Under attenuated conditions, SPLs of all three devices were hardly detectable and interfered with the basal noise of around 50-55 dB (SPL), particularly low and high frequencies ranges were attenuated. CONCLUSION: Pregnancy music belts seem to be a useless tool to support fetal development. The poor sound characteristics of the loudspeakers and the concept of an isolated stimulation appear not promising to effectively support the complex multimodal maturation of the sensory system. Traditional implementation of music appears maternal singing appears more reasonable.

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.

Systematic Reviews on the Prevention of Adverse Pregnancy Outcomes Related to Maternal Obesity to Improve Evidence-Based Counselling.

Background: Health professionals and their patients should understand the importance of evidence. In the case of gestational diabetes mellitus, which is often associated with an abnormally high body mass index, the immediate and long-term outcome of women and their offspring depends in part on advice and implementation of lifestyle changes before, during and after pregnancy. Methods: Up to September 2023, MEDLINE, CENTRAL, and WEB OF SCIENCE were used to identify systematic reviews and meta-analyses on the prevention of gestational diabetes. The ROBIS and AMSTAR criteria were analyzed for all systematic reviews. Results: A total of 36 systematic reviews were identified. Dietary interventions, physical activity or a combined approach all reduced adverse pregnancy outcomes such as gestational diabetes, pregnancy-induced hypertension and related morbidities. Within the randomized controlled trials included in the 36 systematic reviews, the type, intensity and frequency of interventions varied widely. The primary outcomes, reporting and methodological quality of the 36 systematic reviews and meta-analyses also varied.The meta-analysis with the highest ROBIS and AMSTAR-2 scores was selected to design an icon array based on a fact box simulating 100 patients. Conclusions: We propose a methodology for selecting the best evidence and transforming it into a format that illustrates the benefits and harms in a way that can be understood by lay patients, even if they cannot read. This model can be applied to counselling for expectant mothers in low and high-income countries, regardless of socioeconomic status, provided that women have access to appropriately trained healthcare providers.

Systematic review on music interventions during pregnancy in favor of the well-being of mothers and eventually their offspring.

OBJECTIVE: Mental health affects maternal well-being and indirectly affects the development of fetal brain structures and motor and cognitive skills of the offspring up to adulthood. This study aimed to identify specific characteristics of music interventions that improve validated maternal outcomes. DATA SOURCES: Randomized controlled trials and systematic reviews investigating music interventions during pregnancy were identified from the start of data sources up to December 2023 using MEDLINE, the Cochrane Central Register of Controlled Trials, or Web of Science. STUDY ELIGIBILITY CRITERIA: Using Covidence, 2 reviewers screened for randomized controlled trials with ≥3 music interventions during pregnancy and applied either the Perceived Stress Scale score, State-Trait Anxiety Inventory score, Edinburgh Postnatal Depression Scale score, or blood pressure as outcomes. METHODS: The Cochrane risk-of-bias tool 2, the checklist to assess Trustworthiness in RAndomised Clinical Trials, and the reversed Cohen d were applied. This review was registered in the International Prospective Register of Systematic Reviews (registration number: CRD42022299950). RESULTS: From 251 detected records, 14 randomized controlled trials and 2375 pregnancies were included. Music interventions varied from 3 to 84 active or passive sessions with either patient-selected or preselected music and a duration of 10 to 60 minutes per session. Thereby, 2 of 4 studies observed a significant decrease in the Perceived Stress Scale, 8 of 9 studies observed a significant decrease in the State-Trait Anxiety Inventory, and 3 of 4 studies observed a significant decrease in the Edinburgh Postnatal Depression Scale. Blood pressure was significantly reduced in 3 of 4 randomized controlled trials. The Cochrane risk-of-bias tool 2 was "high" in 5 of 14 studies or "with concerns" in 9 of 14 studies. Stratifying the Cohen d in 14 intervention arms suggested a big effect in 234 of 469 mothers on blood pressure and in 244 of 489 mothers on maternal anxiety and a medium effect in 284 of 529 mothers on maternal anxiety. Small or very small effects on blood pressure, the Edinburgh Postnatal Depression Scale, and the Perceived Stress Scale were observed in 35 of 70, 136 of 277, and 374 of 784 mothers-to-be, respectively. CONCLUSION: Our study found a general positive effect of music interventions on maternal stress resilience. This was independent of the music but was influenced by the frequency and empathy of the performances. How far music interventions may improve postnatal development and skills of the offspring should be increasingly evaluated with follow-ups to interrupt vicious epigenetic circles during global pandemics, violent conflicts, and natural catastrophes.