CAG repeat mosaicism is gene specific in spinocerebellar ataxias.

Expanded CAG repeats in coding regions of different genes are the most common cause of dominantly inherited spinocerebellar ataxias (SCAs). These repeats are unstable through the germline, and larger repeats lead to earlier onset. We measured somatic expansion in blood samples collected from 30 SCA1, 50 SCA2, 74 SCA3, and 30 SCA7 individuals over a mean interval of 8.5 years, along with postmortem tissues and fetal tissues from SCA1, SCA3, and SCA7 individuals to examine somatic expansion at different stages of life. We showed that somatic mosaicism in the blood increases over time. Expansion levels are significantly different among SCAs and correlate with CAG repeat lengths. The level of expansion is greater in individuals with SCA7 who manifest disease compared to that of those who do not yet display symptoms. Brain tissues from SCA individuals have larger expansions compared to the blood. The cerebellum has the lowest mosaicism among the studied brain regions, along with a high expression of ATXNs and DNA repair genes. This was the opposite in cortices, with the highest mosaicism and lower expression of ATXNs and DNA repair genes. Fetal cortices did not show repeat instability. This study shows that CAG repeats are increasingly unstable during life in the blood and the brain of SCA individuals, with gene- and tissue-specific patterns.

Maternal and neonatal outcomes of French prospective multicenter cohort study COVIPREG during the first two COVID-19 waves.

BACKGROUND: SARS-CoV-2 infection on pregnant women was the subject of many questions since the COVID-19 pandemic. METHODS: We aim to assess maternal and neonatal outcomes of SARS-CoV-2 infection contracted during 2nd and 3rd trimesters of pregnancy during the first two COVID-19 waves across a prospective French multicenter cohort study. Patients were included between April 2020 and January 2021 in 10 maternity hospitals in Paris area with two groups (i) pregnant women with a positive SARS-CoV-2 nasopharyngeal RT-PCR between [14WG; 37WG[(symptomatic infection), (ii) pregnant women with a negative serology (or equivocal) at delivery and without a positive SARS-CoV-2 nasopharyngeal RT-PCR at any time during pregnancy (G2 group) MAIN FINDINGS: 2410 pregnant women were included, of whom 310 had a positive SARS-CoV-2 nasopharyngeal RT-PCR and 217 between [14WG; 37WG[. Most infections occurred between 28 and 37 weeks of gestation (56 %). Most patients could be managed as outpatients, while 23 % had to be hospitalized. Among women with a positive RT-PCR, multiparous women were over-represented (OR = 2.45[1.52;3.87]); were more likely to deliver before 37 weeks of gestation (OR = 2.19[1.44;3.24]) and overall cesarean deliveries were significantly increased (OR = 1.53[1.09;2.13]). CONCLUSIONS: This study highlights the maternal, obstetrical, and neonatal burden associated with SARS-CoV-2 infections during the first two pandemic waves before availability of vaccines. TRIAL REGISTRATION: NCT04355234 (registration date: 21/04/2020).

Pregnancy and cardiac maternal outcomes in women with inherited cardiomyopathy: interest of the CARPREG II risk score.

AIMS: Inherited cardiomyopathies are relatively rare but carry a high risk of cardiac maternal morbidity and mortality during pregnancy and postpartum. However, data for risk stratification are scarce. The new CARPREG II score improves prediction of prognosis in pregnancies associated with heart disease, though its role in inherited cardiomyopathies is unclear. We aim to describe characteristics and cardiac maternal outcomes in patients with inherited cardiomyopathy during pregnancy, and to evaluate the interest of the CARPREG II risk score in this population. METHODS AND RESULTS: In this retrospective single-centre study, 90 consecutive pregnancies in 74 patients were included (mean age 32 ± 5 years), including 28 cases of dilated cardiomyopathy (DCM), 46 of hypertrophic cardiomyopathy, 11 of arrhythmogenic right ventricular cardiomyopathy and 5 of left ventricular noncompaction, excluding peripartum cardiomyopathy. The discriminatory power of several risk scores was assessed by the area under the receiver-operating characteristic curve (AUC). Median CARPREG II score was 2 [0;3] and was higher in the DCM subgroup. A severe cardiac maternal complication was observed in 18 (20%) pregnancies, mainly driven by arrhythmia and heart failure (each event in 10 pregnancies), with 3 cardiovascular deaths. Forty-three pregnancies (48%) presented foetal/neonatal complications (18 premature delivery, 3 foetal/neonatal death). CARPREG II was significantly associated with cardiac maternal complications (P < 0.05 for all) and showed a higher AUC (0.782) than CARPREG (0.755), mWHO (0.697) and ZAHARA (0.604). CONCLUSIONS: Pregnancy in women with inherited cardiomyopathy carries a high risk of maternal cardiovascular complications. CARPREG II is the most efficient predictor of cardiovascular complications in this population.

Pregnancy, childbirth and postpartum experience in pregnant women infected with SARS-CoV-2 in 2020 in Paris: a qualitative phenomenological study.

BACKGROUND: The COVID-19 pandemic and the resulting lockdowns triggered social discontent on an unprecedented scale. Descriptive phenomenological studies showed that pregnant women were under intense stress during the COVID-19 outbreak, even though they remained uninfected. The purpose of this study was to report on the experiences of pregnant women affected by mild COVID-19 during the first wave of the pandemic. METHODS: In this non- interventional qualitative study, we analyzed pregnant women's experiences using an interpretive phenomenological analysis approach. We conducted semi-structured interviews with women who had had a mild COVID-19 during their pregnancy, and gave birth or planned to give birth in the maternity units of Sorbonne University in Paris, France. RESULTS: Participants reported that at the time they had COVID-19, they were not afraid of being seriously ill, but of transmitting COVID-19 to their close relatives. Their main concern was being pregnant and becoming a parent in a world where the pandemic deeply altered social environment. This included uncertainty about the future and an acute feeling of isolation related to lockdown. The idea that their partner might not be allowed to attend childbirth was almost unanimously felt as intolerable. In contrast, women had positive feelings regarding the fact that lockdown resulted in a de facto paternity leave leading to a certain degree of equality in the couple regarding baby care and household chores. Unexpectedly, the pandemic social distancing measures helped participants escaping from behavioral constraints, including the unspoken rule that they should welcome greetings from friends and family, despite being exhausted by the recent birth. CONCLUSIONS: Our results suggest that avoiding separation from their partner is a key to benevolent medical care for pregnant women in times of health crises. The unexpected benefits women reported in a world of lockdown cast a new light on their expectation regarding parenthood today.

Risk factors for hypoxic-ischemic encephalopathy in cases of severe acidosis: A case-control study.

INTRODUCTION: The aim of the study was to identify the obstetric risk factors for hypoxic-ischemic encephalopathy (HIE) in infants with asphyxia at birth. MATERIAL AND METHODS: This multicenter case-control study covered the 5-year period from 2014 through 2018 and included newborns ≥36 weeks of gestation with an umbilical pH at birth ≤7.0. Cases were newborns who developed moderate or severe HIE; they were matched with controls with pH ≤7.0 at birth over the same period without moderate or severe HIE. The factors studied were maternal, gestational, intrapartum, delivery-related, and neonatal characteristics. A multivariable analysis was performed to study the maternal, obstetric, and neonatal factors independently associated with moderate or severe HIE. RESULTS: Our review of the records identified 41 cases and 98 controls. Compared with controls, children with moderate or severe HIE had a lower 5-min Apgar score, lower umbilical artery pH, and higher cord lactate levels at birth and at 1 h of life. Obstetric factors associated with moderate or severe HIE were the occurrence of an acute event (adjusted odds ratio [aOR] 6.4; 95% confidence interval [CI] 1.8-22.5), maternal fever (aOR 3.5; 95% CI 1.0-11.9), and thick meconium during labor (aOR 2.9; 95% CI 1.0-8.6). CONCLUSIONS: HIE is associated with a lower 5-min Apgar score and with the severity of acidosis at birth and at 1 h of life. In newborns with a pH <7.0 at birth, the occurrence of an acute obstetric event, maternal fever, and thick meconium are independent factors associated with moderate or severe HIE.

Perinatal outcome and need of care for term asphyxiated newborns without moderate or severe hypoxic-ischemic encephalopathy.

AIM: Birth asphyxia can lead to organ dysfunction, varying from isolated biological acidosis to hypoxic-ischemic encephalopathy (HIE). Pathophysiology of moderate or severe HIE is now well known and guidelines exist regarding the care required in this situation. However, for newborns without moderate or severe HIE, no consensus is available. Our objective was to describe the immediate neonatal consequences and need for care of asphyxiated newborns without moderate or severe HIE. METHODS: Multicentre retrospective study from January 2015 to December 2017 in two academic centres, including neonates ≥37 gestational weeks with pathological foetal acidemia (umbilical arterial pH<7.00 and/or lactate≥10 mmol/L). RESULTS: Among 18 550 births, 161 (0.9%) had pathological foetal acidemia. 142 (88.0%) were not diagnosed with moderate or severe HIE. Among them, 82 (58.0%) were hospitalised. 13 (9.0%) had respiratory failure and required nutritional support. 100 (70.0%) underwent blood sampling, which showed at least one biological anomaly in 66 (66.0%) of cases. CONCLUSION: Newborns born with pathological foetal acidemia without the occurrence of moderate or severe HIE had metabolic disorders and could need organ support. A prospective study describing this vulnerable population would help to establish consensus guidelines for the management of this population.

Prevalence and incidence of postpartum depression and environmental factors: The IGEDEPP cohort.

BACKGROUND: IGEDEPP (Interaction of Gene and Environment of Depression during PostPartum) is a prospective multicenter cohort study of 3310 Caucasian women who gave birth between 2011 and 2016, with follow-up until one year postpartum. The aim of the current study is to describe the cohort and estimate the prevalence and cumulative incidence of early and late-onset postpartum depression (PPD). METHODS: Socio-demographic data, personal and family psychiatric history, as well as stressful life events during childhood and pregnancy were evaluated at baseline. Early and late-onset PPD were assessed at 8 weeks and 1 year postpartum respectively, using DSM-5 criteria. RESULTS: The prevalence of early-onset PPD was 8.3% (95%CI 7.3-9.3), and late PPD 12.9% (95%CI 11.5-14.2), resulting in an 8-week cumulative incidence of 8.5% (95%CI 7.4-9.6) and a one-year cumulative incidence of PPD of 18.1% (95%CI: 17.1-19.2). Nearly half of the cohort (N = 1571, 47.5%) had a history of at least one psychiatric or addictive disorder, primarily depressive disorder (35%). Almost 300 women in the cohort (9.0%) reported childhood trauma. During pregnancy, 47.7% women experienced a stressful event, 30.2% in the first 8 weeks and 43.9% between 8 weeks and one year postpartum. Nearly one in five women reported at least one stressful postpartum event at 8 weeks. CONCLUSION: Incident depressive episodes affected nearly one in five women during the first year postpartum. Most women had stressful perinatal events. Further IGEDEPP studies will aim to disentangle the impact of childhood and pregnancy-related stressful events on postpartum mental disorders.

Childbirth and motherhood in women with motor disability due to a rare condition: an exploratory study.

BACKGROUND: Rare diseases may result in motor impairment, which in turn may affect parenthood. Our purpose was to evaluate perinatal outcomes, parenting needs, mother-infant interactions and infant development in a set of volunteer women with motor impairment due to a rare disease. In a parenting support institution, we recruited a consecutive series of 22 volunteer pregnant women or young mothers, recorded perinatal outcomes, and followed mother-infant interaction and relationship and infant development up to 14 months postpartum. Cases with intellectual or psychic disability were not included. RESULTS: There were 11 genetic diseases (2 Spinal Muscular Atrophy, 1 Charcot-Marie-Tooth, 1 autosomal dominants myopathy, 1 mitochondrial disease, 2 Elhers-Danlos, 1 Friedreich ataxia, 1 spinocerebellar ataxia, 1 tetrahydrobiopterine deficiency,1 Ectrodactyly), and 11 rare non-genetic conditions (2 spine tumors, 2 strokes, 1 juvenile chronic arthritis, 3 birth injuries, 1 inflammatory myopathy, 1 congenital amputation, and 1 traumatic amputation). These resulted in 10 impairments of four limbs, 4 impairments of both lower limbs, 7 unilateral impairments, and one distal tremor. Social deprivation Epices score, Cutrona social support scale, Edinburg Postnatal Depression scale, and Spielberger State/Trait Anxiety Inventory were unremarkable. Perinatal outcome: 4 gestational diabetes, 1 pre-eclampsia, 9 caesareans, 6 assisted and 7 spontaneous vaginal deliveries, 20 term live-births and 2 premature deliveries (35-36 weeks). Twelve women declared they were self-sufficient for daily activities; six declared they were self-sufficient to provide basic care to their baby. Distribution of the Brunet-Lezine child development score was normal. The parent-infant relationship global assessment scale (PIR-GAS) was well adapted in 2 cases, adapted in 8, perturbed in 7, significantly perturbed in 2, and distressed in 3 (mean 71.8; 95% CI 49.6-93.9). This was unrelated to any somatic or emotional characteristics of the participants. Coding interactive behavior revealed that infant engagement was lower and infant avoidance greater than in controls (p < 0.05). CONCLUSION: Infant development was normal, but mother-infant interactions were altered in half of the participants independently from the degree of motor impairment, underscoring the need for parenting support, even for parents who are self-sufficient in daily activities.

"Motherese" Prosody in Fetal-Directed Speech: An Exploratory Study Using Automatic Social Signal Processing.

Introduction: Motherese, or emotional infant directed speech (IDS), is the specific form of speech used by parents to address their infants. The prosody of IDS has affective properties, expresses caregiver involvement, is a marker of caregiver-infant interaction quality. IDS prosodic characteristics can be detected with automatic analysis. We aimed to explore whether pregnant women "speak" to their unborn baby, whether they use motherese while speaking and whether anxio-depressive or obstetrical status impacts speaking to the fetus. Participants and Methods: We conducted an observational study of pregnant women with gestational ages from 26 to 38 weeks. Women were recruited in a university hospital department of obstetrics. Thirty-five women agreed to participate in the study, and 26 audio records were exploitable. We collected obstetrical and sociodemographic data, pregnancy outcomes, anxiety and depressive status using the Covy and Raskin Scales, and life events using the Sensations During Pregnancy and Life Event Questionnaire. Each participant was left alone with an audio recorder with a recommendation to feel free to speak to her fetus as she would have done at home. The recording was stopped after 3 min. Audio recordings were analyzed by two methods: psycholinguist experts' annotation and computational objective automatic analyses. Results: Most mothers (89%) reported speaking to their fetuses. We found a correlation between maternal first perceptions of fetal movements and the start of mother's speaking to fetus. Motherese prosody was detected with both annotation and automatic analysis with a significant correlation between the two methods. In this exploratory study, motherese use was not associated with maternal anxiodepressive or obstetrical status. However, the more future mothers were depressed, the less they spoke with their fetuses during the recording. Conclusion: Fetal directed speech (FDS) can be detected during pregnancy, and it contains a period of prosody that shares the same characteristics of motherese that can be described as prenatal motherese or emotional fetal-directed speech (e-FDS). This means that pregnant women start using motherese much earlier than expected. FDS seems to be correlated with maternal first perceptions of fetal movements and depression scores. However, more research is needed to confirm these exploratory results.

Benefits of using a simulator in the initial training for transvaginal ultrasound examination in gynecologic emergency unit.

PURPOSE: Transvaginal ultrasound examination is decisive in Gynecologic emergency unit. This study's aim was to evaluate benefits of using a simulator for initial training of medical student for transvaginal ultrasound examination. METHOD: A multicenter randomized trial was conducted. Medical student were randomized in two groups: in the intervention group, students took part in a simulation session in addition to the companionship-training while in the control group, they were only trained by companionship. To evaluate their progression, the quality of ultrasound pictures performed in real conditions before (pre-test) and after (post-test) the training by the students of both groups were evaluated and compared. Evaluation was performed according to predefined quality criterias for each ultrasound examination using a score of 20 points. Mean scores of students in both groups were compared for the pre and post-test. RESULTS: Fifty six medical students were included. Mean scores of the 56 students were significantly better at the post-test than at the pre-test: 10,61/20 [9,62-11, 59] vs 6,35/20 [5,48-7,24], p < 0,001. Mean scores were significantly better at the post-test for students in the intervention group (n = 29) than in the control group (n = 27) 11,79/20 [7,72-10,94] vs 9,33/20 [7,72-10,94], p = 0,01. All the students in the intervention group were satisfied or highly satisfied to take part in this program. CONCLUSIONS: Using a simulator for medical student was beneficial in the initial training of transvaginal ultrasound examination.

SARS-COV-2 IgG antibody response in pregnant women at delivery.

BACKGROUND: The prevalence of COVID-19 infection during pregnancy is not known. COVIPREG is a prospective French multicenter study to assess the seroprevalence at the time of delivery and the maternal and neonatal impact of COVID-19 infection during pregnancy. In order to study factors associated with poor outcomes after COVID-19 Infection during pregnancy and adapt the sample size of the study, a preliminary assessment of the prevalence of SARS-CoV-2 IgG was planned after 500 inclusions in a one perinatal center of Paris area. OBJECTIVES: To assess the prevalence of SARS-CoV-2 IgG antibody response in pregnant women at the time of delivery during the COVID-19 pandemia. STUDY DESIGN: A prospective observational study at Cochin hospital (Level III maternity). Patients admitted for delivery were offered to participate to the study. Each patient participating to the study was tested for anti-SARS-CoV-2-IgG antibodies using a commercially available ELISA. RESULTS: Among the 529 patients included in the COVIPREG study between April 29 and June 26, 529 were assessed for SARS-CoV-2 IgG antibody response and 25 had a positive test, ie 4.7 % with a confidence interval at 95 % [3.0 %-6.9 %]). CONCLUSIONS: Four months after the beginning of the infection in Paris, the seroprevalence of SARS-CoV-2 IgG in pregnant women at the time of delivery is low. Studies evaluating the impact of COVID-19 infection during pregnancy should take this information in account in order to adapt the sample size.

Relative Contribution of Gestational Weight Gain, Gestational Diabetes, and Maternal Obesity to Neonatal Fat Mass.

Maternal nutritional and metabolic status influence fetal growth. This study investigated the contribution of gestational weight gain (GWG), gestational diabetes (GDM), and maternal obesity to birthweight and newborn body fat. It is a secondary analysis of a prospective study including 204 women with a pregestational body mass index (BMI) of 18.5-24.9 kg/m2 and 219 women with BMI ≥ 30 kg/m2. GDM was screened in the second and third trimester and was treated by dietary intervention, and insulin if required. Maternal obesity had the greatest effect on skinfolds (+1.4 mm) and cord leptin (+3.5 ng/mL), but no effect on birthweight. GWG was associated with increased birthweight and skinfolds thickness, independently from GDM and maternal obesity. There was an interaction between third trimester weight gain and GDM on birthweight and cord leptin, but not with maternal obesity. On average, +1 kg in third trimester was associated with +13 g in birthweight and with +0.64 ng/mL in cord leptin, and a further 32 g and 0.89 ng/mL increase in diabetic mothers, respectively. Maternal obesity is the main contributor to neonatal body fat. There is an independent association between third trimester weight gain, birthweight, and neonatal body fat, enhanced by GDM despite intensive treatment.

Huntington's disease alters human neurodevelopment.

Although Huntington's disease is a late-manifesting neurodegenerative disorder, both mouse studies and neuroimaging studies of presymptomatic mutation carriers suggest that Huntington's disease might affect neurodevelopment. To determine whether this is actually the case, we examined tissue from human fetuses (13 weeks gestation) that carried the Huntington's disease mutation. These tissues showed clear abnormalities in the developing cortex, including mislocalization of mutant huntingtin and junctional complex proteins, defects in neuroprogenitor cell polarity and differentiation, abnormal ciliogenesis, and changes in mitosis and cell cycle progression. We observed the same phenomena in Huntington's disease mouse embryos, where we linked these abnormalities to defects in interkinetic nuclear migration of progenitor cells. Huntington's disease thus has a neurodevelopmental component and is not solely a degenerative disease.

Ultrasound features of fetal toxoplasmosis: A contemporary multicenter survey in 88 fetuses.

OBJECTIVE: To describe the lesions detected by prenatal ultrasound examination in congenital toxoplasmosis (CT). METHODS: We retrospectively analyzed all cases of fetal infection with Toxoplasma gondii with ultrasound anomalies described by fetal medicine experts in 2009 to 2019 in 30 French centers. RESULTS: Eighty-eight cases of CT were included. Forty-five (51.1%) had one or more cerebral signs only, 35 (39.8%) had cerebral plus extracerebral signs and 8 (9.1%) had extracerebral signs only. The main cerebral signs were intracranial hyperechogenic nodular foci (n = 60) of which 20 were isolated, ventriculomegalies (n = 44) which generally increased during follow-up, and periventricular abscesses (n = 12). The main extracerebral signs were hepatomegaly and/or splenomegaly (n = 14), small for gestational age (n = 14), ascites (n = 14, including 2 with hydrops), and hyperechogenic bowel (n = 11). Maternal infection occurred mostly in the first or second trimester (81 cases), periconceptionally in one and in the third trimester in six cases. The first ultrasound signs were detected after a median of 7 weeks (range: 1.4; 24.0) following maternal toxoplasmosis seroconversion. CONCLUSION: While no sign was specific of CT, there were typical associations of cerebral signs with or without extracerebral signs. Detailed ultrasound examination could improve prognostic evaluation, as well as diagnosis of CT in settings lacking serological screening.

Evolution of third-trimester pregnancy terminations in France.

OBJECTIVE: To study changes in the reasons for third-trimester termination of pregnancy (TOP) for fetal anomalies over a 20-year period in France. STUDY DESIGN: We compared a consecutive series of third-trimester TOPs from a single centre in 2005-2014 to those performed by Dommergues et al. in a similar centre in 1986-1994, using the same criteria. MAIN OUTCOME MEASURES: The process leading to late TOP, using the same categories in both studies. RESULTS: In the present series, 205 of 1409 TOPs were performed in the third trimester, vs. 305/956 in the historical series. There were 33 (16.1 %) diagnoses missed at the screening before the third trimester, 55 (26.8 %) cases in which the anomaly was impossible to diagnose until the third trimester, 86 (42 %) cases in which fetal prognosis could not be established until the third trimester despite earlier diagnosis, 31 (15.1 %) TOPs postponed to allow more time for the women/couples to contemplate, versus respectively 113 (37 %), 55 (18 %), 122 (40 %), and 15 (5%) in the historical series. CONCLUSION: There was a significant drop in the rate of anomalies missed earlier. The increase in late TOP due to couples requiring additional time for contemplation might result from changes in counselling processes.

Causes of fever in pregnant women with acute undifferentiated fever: a prospective multicentric study.

The etiologies of undifferentiated fever in pregnant women have not been studied thoroughly. Because of its non-specific presentation but severe prognosis, listeriosis is often suspected in this setting, but in most cases not confirmed. We studied the causes of undifferentiated fever in pregnant women who received preemptive listeriosis treatment. We conducted from November 1, 2011, to June 30, 2013, a prospective multicentric observational cohort study of pregnant women referred to obstetrical wards with undifferentiated fever and who received listeriosis preemptive treatment. Clinical and biological features, treatment, outcome, and final diagnosis were collected. We enrolled 103 febrile pregnant women. A cause was identified in 77/103 (75%): viral infection in 52/103 (50%, influenza in 21 (20%)), bacterial infection in 22 (21%, including 16 pyelonephritis (16%) and 3 pneumonias (3%)), and TORCH infection in 3 (3%, varicella, toxoplasmosis, and cytomegalovirus primo-infections, n=1, each). Viral infections collected during influenza outbreaks (December-March) accounted for 43/57 (75%) cases. Two fetal losses were reported in the context of febrile pneumonia. Final diagnoses required adapting medical care in 46/77 (60%) of cases, for bacterial, influenza, or TORCH infections. A large array of benign to potentially severe infections manifests as acute undifferentiated fever in pregnant women, requiring careful repeated evaluation.

Pregnancy denial and early infant development: a case-control observational prospective study.

BACKGROUND: The denial of pregnancy is the non-recognition of the state of the current pregnancy by a pregnant woman. It lasts for a few months or for the whole pregnancy, with generally few physical transformations. In this study, we will consider the denial of pregnancy as a late declaration of pregnancy (beyond 20 weeks of gestation) as well as a lack of objective perceptions of this pregnancy. The main objective of this study is to explore the relationship between pregnancy denial and the development of the infant (attachment pattern of the infant, early interactions of mother-infant dyads, and early development of the infant). METHODS: The design is a case-control prospective study, which will compare two groups of mother-infant dyads: a "case" group with maternal denials of pregnancy and a "control" group without denials of pregnancy. A total of 140 dyads (mother + infant) will be included in this study (70 cases and 70 controls) and followed for 18 months. The setting is a national recruitment setting with 10 centers distributed all over France. The follow-up of the "cases" and the "controls" will be identical and will occur over 5 visits. It will include measures of the infant attachment pattern, the quality of early mother-infant interaction and infant development. DISCUSSION: This study aims to examine the pathogenesis of pregnancy denial as well as its consequences on early infant development and early mother-infant interaction. TRIAL REGISTRATION: Clinical Trial Number: NCT02867579 on the date of 16 August 2016 (retrospectively registered).

Cost-effectiveness of acupuncture versus standard care for pelvic and low back pain in pregnancy: A randomized controlled trial.

OBJECTIVE: To assess the cost-effectiveness of acupuncture for pelvic girdle and low back pain (PGLBP) during pregnancy. DESIGN: Pragmatic-open-label randomised controlled trial. SETTING: Five maternity hospitals. POPULATION: Pregnant women with PGLBP. METHOD: 1:1 randomization to standard care or standard care plus acupuncture (5 sessions by an acupuncturist midwife). MAIN OUTCOME MEASURE: Efficacy: proportion of days with self-assessed pain by numerical rating scale (NRS) ≤ 4/10. Cost effectiveness (societal viewpoint, time horizon: pregnancy): incremental cost per days with NRS ≤ 4/10. Indirect non-healthcare costs included daily compensations for sick leave and productivity loss caused by absenteeism or presenteeism. RESULTS: 96 women were allocated to acupuncture and 103 to standard care (total 199). The proportion of days with NRS ≤ 4/10 was greater in the acupuncture group than in the standard care group (61% vs 48%, p = 0.007). The mean Oswestry disability score was lower in the acupuncture group than with standard care alone (33 versus 38, Δ = 5, 95% CI: 0.8 to 9, p = 0.02). Average total costs were higher in the control group (€2947) than in the acupuncture group (€2635, Δ = -€312, 95% CI: -966 to +325), resulting from the higher indirect costs of absenteeism and presenteeism. Acupuncture was a dominant strategy when both healthcare and non-healthcare costs were included. Costs for the health system (employer and out-of-pocket costs excluded) were slightly higher for acupuncture (€1512 versus €1452, Δ = €60, 95% CI: -272 to +470). CONCLUSION: Acupuncture was a dominant strategy when accounting for employer costs. A 100% probability of cost-effectiveness was obtained for a willingness to pay of €100 per days with pain NRS ≤ 4.