Magnetic Resonance Imaging Angiography of Physiological and Pathological Pregnancy Placentas Ex Vivo: Protocol for a Prospective Pilot Study.

BACKGROUND: Preeclampsia (PE) and intrauterine growth restriction (IUGR) are 2 major pregnancy complications due to abnormal placental vasculogenesis. Data on whole fetoplacental vasculature are still missing; hence, these pathologies are not well understood. Ex vivo magnetic resonance imaging (MRI) angiography has been developed to characterize the human placental vasculature by injecting a contrast agent within the umbilical cord. OBJECTIVE: The primary objective of this study is to compare the placental vascular architecture between normal and pathological pregnancies. This study's secondary objectives are to (1) compare texture features on MRI between groups (normal and pathological), (2) quantitatively compare the vascular architecture between both pathological groups (pathological IUGR, and pathological PE), (3) evaluate the quality of the histological examination in injected placentas, and (4) compare vascularization indices to histological characteristics. METHODS: This is a prospective controlled study. We expect to include 100 placentas: 40 from normal pregnancies and 60 from pathological pregnancies (30 for IUGR and 30 for PE). Ex vivo MR image acquisition will be performed shortly after delivery and with preparation by injection of a contrast agent in the umbilical cord. The vascular architecture will be quantitatively described by vascularization indices measured from ex vivo MRI angiography data. Comparisons of vascularization indices and texture features in accordance with the group and within comparable gestational age will be also performed. After MR image acquisition, placental histopathological analysis will be performed. RESULTS: The enrollment of women began in November 2019. In view of the recruitment capacity of our institution and the availability of the MRI, recruitment should be completed by March 2022. As of November 2021, we enrolled 70% of the intended study population. CONCLUSIONS: This study protocol aims to provide information about the fetal side of placental vascular architecture in normal and pathological placenta through MRI. TRIAL REGISTRATION: Clinicaltrials.gov NCT04389099; https://clinicaltrials.gov/ct2/show/NCT04389099. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35051.

Functional MRI-based study of emotional experience in patients with psychogenic non-epileptic seizures: Protocol for an observational case-control study-EMOCRISES study.

BACKGROUND: Psychogenic non epileptic seizures (PNES) are a frequent, disabling and costly disorder for which there is no consensual caring. They are considered as a dissociative disorder and they share many common characteristics with post-traumatic stress disorder (PTSD). Nevertheless, their pathophysiology is still unclear. In this study, we plan to obtain new data comparing functional brain activity of participants suffering from PNES, from PTSD and healthy controls via functional brain MRI during resting state and under emotional visual stimulation. The protocol presented hereunder describes an observational study with no direct treatment implication. Nevertheless, it could lead to a better understanding of PNES and to identifying targets for specialised cares of post-traumatic or dissociative disorders, like repetitive transcranial magnetic stimulation. METHODS & ANALYSIS: This is a prospective, single-centre, interventional, non-randomized, open, controlled and exploratory clinical study. It will involve 75 adult French, right-handed women in 3 groups, either suffering from PNES or PTSD, or healthy controls. An informed consent will be signed by each participant. All of them will be given psychiatric tests to assess dissociation and alexithymia, psychopathological profile and history, and emotional recognition. Each participant will undergo a functional brain MRI. We will record anatomical images and five functional imaging sequences including emotional periodic oscillatory stimulation, standard emotional stimulation, Go / No Go task under emotional stimulation, and resting state. Analysis will include a descriptive analysis of all participants and the treatment for functional magnetic resonance imaging images of each sequence. REGISTRATION, ETHICS & DISSEMINATION: This study was approved the regional Protection of Persons Committee under the reference 16.10.01 and by the French National Medical Security Agency under the reference 2016-A01295-46. The protocol and results will be published in peer-reviewed academic medical journals and disseminated to research teams, databases, specialised media and concerned patients' organisations.

Comparative evaluation of the impact of the COVID-19 lockdown on perinatal experience: A prospective multicentre study.

OBJECTIVES: To compare in the early postpartum the perinatal experience during a COVID-19 related lockdown ('lockdown' group) and a pandemic control group subject to looser restrictions. DESIGN AND SETTING: This national multicentre prospective cohort study took place in four French maternity units. POPULATION: Women were recruited during the postpartum stay for the lockdown and pandemic control groups, according to their enrolment period. Both faced the same labour and delivery restrictions but only the pandemic control group could have a postpartum visitor. MAIN OUTCOME MEASURES: The primary outcome was the perinatal experience during childbirth, assessed by the Labour Agentry Scale (LAS) self-administered questionnaire, completed before discharge. RESULTS: The study included 596 women and analysed 571 of them: 260 in the lockdown group and 311 in the pandemic control group. The mean LAS score was lower in the lockdown group (161.1 ± 26.8, 95% confidence interval [CI] 157.8-164.3 versus 163.3 ± 24.0, 95% CI 160.6-166.0; P = 0.289). In multivariable analysis, the LAS score was lower in the lockdown group (-6.2 points, P = 0.009), in women with caesarean (-21.6 points, P < 0.001) versus spontaneous deliveries, and among women financially impacted by the lockdown (-6.4 points, P = 0.007) or who experienced restrictions during childbirth (-8.1 points, P < 0.001). The LAS score rose with the prenatal care quality score (P < 0.001). CONCLUSIONS: The perinatal experience was more negatively affected by lockdown restrictions than by the looser pandemic restrictions for controls, but mode of delivery remained the main factor influencing this experience.

Birth experience during COVID-19 confinement (CONFINE): protocol for a multicentre prospective study.

INTRODUCTION: The absence of companionship during childbirth is known to be responsible for negative emotional birth experience, which can increase the risk of postpartum depression and post-traumatic stress disorder. The context of COVID-19 epidemic and the related confinement could increase the rate of negative experience and mental disorders. The main objective is to compare, in immediate post partum, the maternal sense of control during childbirth between a group of women who gave birth during confinement ('confinement' group) versus a group of women who gave birth after confinement but in the context of epidemic ('epidemic' group) versus a group of control women ('control' group; excluding confinement and epidemic context). METHODS AND ANALYSIS: This is a national multicentre prospective cohort study conducted in four French maternity units. We expect to include 927 women in a period of 16 months. Women will be recruited immediately in post partum during three different periods constituting the three groups: 'confinement'; 'epidemic' and 'control' group. The maternal sense of control will be evaluated by the Labour Agentry Scale questionnaire completed immediately in post partum. Postnatal depression (Edinburgh Postnatal Depression Scale), post-traumatic stress disorder (Impact of Event Scale-Revised) and breast feeding (evaluative statement) will be evaluated at 2 months post partum. ETHICS AND DISSEMINATION: The study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) SUD OUEST ET OUTRE-MER IV on 16th of April 2020 with reference number CPP2020-04-040. The results of this study will be published in a peer-reviewed journal and will be presented at relevant conferences. TRIAL REGISTRATION NUMBER: NCT04348929.

First trimester screening for pre-eclampsia and intrauterine growth restriction using three-dimensional Doppler angiography (SPIRIT): protocol for a multicentre prospective study in nulliparous pregnant women.

INTRODUCTION: Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are two major pregnancy complications, related to chronic uteroplacental hypoperfusion. Nowadays, there is no screening or diagnostic test for uteroplacental vascularisation deficiency in pregnant women. Since 2004, 3 three-imensional power Doppler (3DPD) angiography has been used for the evaluation of uteroplacental vascularisation and three vascular indices are usually calculated: Vascularisation Index (VI), Flow Index (FI) and vascularisation-FI (VFI). A high intraobserver and interobserver reproducibility and a potential interest for placental function study were reported by our team and others.The main objective of our study is to determine differences in 3DPD indices at first trimester between pregnancies defined at their outcome as uncomplicated pregnancy, PE (mild and severe) and IUGR in nulliparous women. METHODS AND ANALYSIS: This is a national multicentre prospective cohort study conducted in four French maternity units. We expect to include 2200 women in a period of 36 months. The nulliparous pregnant women will be recruited during their first trimester consultation (11-13+6 gestation week (GW)).The 3DPD and uterine artery Doppler acquisition will be included in the current routine 11-13+6 GW ultrasound. Also, additional blood samples will be taken for biomarker analysis (PAPP-A and P1GF) and biological collection. Uteroplacental VIs (FI and VFI) will be measured. For each subgroup (uncomplicated pregnancy, PE and IUGR), mean values in 3DPD indices will be computed and compared using a pairwise t test with a Bonferroni correction p value adjustment. ETHICS AND DISSEMINATION: The study was approved by the French Ethics Committee, the Comité de Protection des Personnes SUD MEDITERRANEE IV on 13 February 2018 with reference number 17 12 03. The results of this study will be published in a peer-reviewed journal and will be presented at relevant conferences. TRIAL REGISTRATION NUMBER: NCT03342014; Pre-results. PHRCN-16-0567.

Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA): protocol for a prospective cross-sectional study.

CONTEXT: Variability in 2D ultrasound (US) is related to the acquisition of planes of reference and the positioning of callipers and could be reduced in combining US volume acquisitions and anatomical structures recognition. OBJECTIVES: The primary objective is to assess the consistency between 3D measurements (automated and manual) extracted from a fetal US volume with standard 2D US measurements (I). Secondary objectives are to evaluate the feasibility of the use of software to obtain automated measurements of the fetal head, abdomen and femur from US acquisitions (II) and to assess the impact of automation on intraobserver and interobserver reproducibility (III). METHODS AND ANALYSIS: 225 fetuses will be measured at 16-30 weeks of gestation. For each fetus, six volumes (two for head, abdomen and thigh, respectively) will be prospectively acquired after performing standard 2D biometry measurements (head and abdominal circumference, femoral length). Each volume will be processed later by both a software and an operator to extract the reference planes and to perform the corresponding measurements. The different sets of measurements will be compared using Bland-Altman plots to assess the agreement between the different processes (I). The feasibility of using the software in clinical practice will be assessed through the failure rate of processing and the score of quality of measurements (II). Interclass correlation coefficients will be used to evaluate the intraobserver and interobserver reproducibility (III). ETHICS AND DISSEMINATION: The study and related consent forms were approved by an institutional review board (CPP SUD-EST 3) on 2 October 2018, under reference number 2018-033 B. The study has been registered in https://clinicaltrials.gov registry on 23 January 2019, under the number NCT03812471. This study will enable an improved understanding and dissemination of the potential benefits of 3D automated measurements and is a prerequisite for the design of intention to treat randomised studies assessing their impact. TRIAL REGISTRATION NUMBER: NCT03812471; Pre-results.