Safety and efficacy of the OdonAssist inflatable device for assisted vaginal birth: the BESANCON ASSIST study.

BACKGROUND: The first feasibility study of the OdonAssist inflatable device for use in clinically indicated assisted vaginal birth reported a success rate of 48% with no significant safety concerns. Additional studies exploring the device performance in other clinical settings are warranted before definitive conclusions can be drawn about its safety and efficacy in current practice. OBJECTIVE: This study aimed to investigate the safety and efficacy of the OdonAssist before conducting a randomized controlled trial. STUDY DESIGN: This was an open-label, nonrandomized study of 104 women with a clinically indicated assisted vaginal birth using the OdonAssist at the Besancon University Hospital, France. Data, including those of a nested cohort group of women who had an assisted vaginal birth using vacuum or spatulas because a trained OdonAssist device operator was not available at the time of delivery, were collected. The primary outcome measure was the proportion of successful assisted vaginal births using the OdonAssist. Neonatal outcome data were reviewed at days 1 and 28, and maternal outcomes were investigated up to day 90. RESULTS: Between December 2019 and May 2021, 2191 pregnant women were approached, and 83% (1636/1973) of them consented to participate in the study. Among them, 10.7% (176/1636) required an assisted vaginal birth owing to a vertex presentation at +1 and below. The OdonAssist was used in 59% of births (104/176), and 41.1% (72/176) of the participants were included in the nested cohort group. The rate of successful assisted vaginal births using the OdonAssist was 88.5% (92/104). No emergency cesarean deliveries were performed in the OdonAssist group. There were no serious adverse maternal or neonatal reactions related to the use of the device. The rate of third- and fourth-degree perineal tears with the OdonAssist was 3.8% (4/104). The maternal perception ratings of the birth experience with the OdonAssist (collected on days 1, 7, and 28 using a 15-point scale) were high. In addition, the operators reported a positive perception of the device, with ease of use across the different steps of the procedure. One single technique was used for all vertex fetal head positions. CONCLUSION: The OdonAssist is a safe and effective alternative to other current devices for assisted vaginal births. The high acceptance rate (83%) among pregnant women and the high rate of successful assisted vaginal births using the OdonAssist confirm the feasibility of a future randomized controlled trial.

Prenatal quantification of human foetal lung and liver elasticities between 24 and 39 weeks of gestation using 2D shear wave elastography.

OBJECTIVES: To quantify and model normal foetal lung and liver elasticities between 24 and 39 weeks of gestation (WG) using two-dimensional shear wave elastography (2D-SWE). To assess the impact of the distance between the probe and the target organ on the estimation of elasticity values. METHODS: Measurements of normal foetal lungs and liver elasticity were prospectively repeated monthly between 24 and 39 WG in 72 foetuses using 2D-SWE. Elasticity was quantified in the proximal lung and in the region inside the hepatic portal sinus. The distance between the probe and the target organ was recorded. Trajectories representing foetal lung and liver maturation from at least 3 measurements over time were modelled. RESULTS: The average elasticity for the lung and liver was significantly different from 24 WG to 36 WG (p < 0.01). Liver elasticity increased during gestation (3.86 kPa at 24 WG versus 4.45 kPa at 39 WG). From 24 WG to 32 WG, lung elasticity gradually increased (4.12kPa at 24 WG, 4.91kPa at 28 WG, 5.03kPa at 32 WG, p < 0.002). After 32 WG, lung elasticity decreased to 4.54kPa at 36 WG and 3.94kPa at 39 WG. The dispersion of the average elasticity values was greater for the lung than for the liver (p < 0.0001). Variation in the elasticity values was less important for the liver than for the lung. The values were considered valid and repeatable except for a probe-lung distance above 8cm. CONCLUSION: Foetal lung and liver elasticities evolve differently through gestation. This could reflect the tissue maturation of both organs during gestation. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT03834805 KEY POINTS: • Prenatal quantification of foetal lung elasticity using 2D shear wave elastography could be a new prenatal parameter for exploring foetal lung maturity. • Liver elasticity increased progressively from 24 weeks of gestation (WG) to 39 WG, while lung elasticity increased first between 24 and 32 WG and then decreased after 32 WG. • The values of elasticity are considered valid and repeatable except for a probe-lung distance above 8cm.

Evolution of fetal lung stiffness during gestation in two different congenital malformations.

This report is aimed at opening a new reflexion about exploration of fetal lungs malformations with 2-D ultrasound shear wave elastography (2D-SWE) in two fetuses. These preliminary results are drawn from the ELASTOMAP study, which was designed to explore feasibility of 2D-SWE on fetal lungs. Fetus A presented Congenital Pulmonary Airway Malformation and fetus B congenital obstructive emphysema. We estimated every 3 weeks the Congenital Pulmonary Airway Malformation Volume Ratio (CVR) of the malformation and we evaluated stiffness by 2D-SWE. Stiffness of the lesion and the normal lung were compared to liver stiffness using Lung to Liver Elastography (LLE) ratio. Interestingly, CVR and LLE ratios evolved differently in these two lesions caused by distinct physiopathological processes. In both cases, LLE ratio' variations preceded that of CVR. LLE ratio of the normal lung was constant through gestation. 2D-SWE could be a promising tool to describe stiffness evolution in fetal lungs malformations.

Analysis of spontaneous labor progression of breech presentation at term.

BACKGROUND: Cervical dilatation curves are widely used to describe normal and abnormal labor progression for cephalic presentation. Labor curves for breech presentations have never been described. OBJECTIVES: The aims of this study were to examine the pattern of labor progression in women with a breech presentation and to determine whether the type of breech or parity can influence the speed of cervical dilatation. STUDY DESIGN: We analyzed the labor data from 349 women with a term, singleton, and breech fetus after spontaneous onset of labor in 2010-2018. Cesarean deliveries were excluded. The patterns of labor progression were described by examining the relationship between the elapsed times from the full dilatation and cervical dilatation stages. Average labor curves were developed using repeated-measures analysis with 3rd degree polynomial modeling. The results were interpreted according to parity and the type of breech. RESULTS: The first stage of labor progression was divided into a latency phase from 0 to 5 cm of dilatation and an active phase from 5 to 10 cm. In the active phase, the median speed of cervical dilatation was 1.67 cm/h [1.25, 2.61] (2 cm/h for multipara and 1.54 cm/h for nullipara). The difference by parity was significant in the active phase (p< 0.05). The cervical dilatation rate from 3 cm to 10 cm did not significantly differ between the complete and frank breeches (1.56 cm/h vs 1.75 cm/h, p = 0.48). However, the median cervical dilatation rate from 8 cm to complete dilatation was faster for complete breeches (1.92 cm/h versus 1.33 cm/h, p = 0.045). CONCLUSION: As with cephalic presentation, the first stage of labor progression for breech presentation can be divided into a latent and active phase. Labor progression should be interpreted with respect to parity, and women should be informed that the type of breech does not seem to influence the cervical dilatation rate when there is adequate management.

Intra pelvic spontaneous rotation of persistent occiput posterior position in case of operative vaginal delivery with spatulas.

OBJECTIVES: In 5 % of vaginal deliveries in case of cephalic presentation there is a persistent occipital posterior position known to be associated with a higher maternal and neonatal morbidity. In these situations, vacuum extractor seems to be the best choice for assisted delivery but it also has limits and contraindications, for example an important caput succadenum or premature birth. The aim of our study was to evaluate the rate of intra-pelvic rotation of persistent occipital posterior position without instrumental rotation in case of operative delivery with spatulas. METHODS: This is a retrospective, monocentric and descriptive study evaluating the rate of spontaneous intra-pelvic rotation of persistent occipital posterior position in case of assisted delivery with spatulas among all live births at the Besançon University Medical Center between 2010 and 2017. RESULTS: There were 20 205 births during the study and 81(0,4 %) operative deliveries by spatulas in case of persistent occipital posterior position. Delivery in occiput anterior (OA) position was obtained in 36 cases (44.4 %). There was no significant difference in maternal or neonatal morbidity between both groups and perineum injuries were less severe in case of OA delivery. CONCLUSION: Operative deliveries by spatulas without instrumental rotation in case of persistent occipital-posterior position seem to be a relevant alternative to vacuum extractor, especially in case of premature birth or important caput succedaneum without altering the maternal or neonatal prognostic.

Arsenic Trioxide Treatment during Pregnancy for Acute Promyelocytic Leukemia in a 22-Year-Old Woman.

Acute leukemia during pregnancy is rare (1 for 100000 pregnancies). The association of arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) is known as the best therapy in standard-risk acute promyelocytic leukemia (APL). We describe the first case of a pregnancy with ATRA and ATO reported in the literature. In March 2018 at the University Hospital of Besançon, a 22-year-old woman was diagnosed with APL at 14 weeks of gestation (WG). She received a total of 2160 mg of ATRA and 930 mg of ATO between 14 and 35 WG. The mother's cytological remission was very fast. No maternal or fetal complications occurred during pregnancy. The pediatrics outcomes were good. Many case reports about ATRA exposure during the second and third trimesters report no serious adverse effect for pregnancy. ATO is teratogenic, genotoxic, and carcinogenic and passes through the placenta. Fetal exposure seems to be associated with bad pregnancy outcomes (preterm delivery, decreased birth weight, and fetal loss) and with lung diseases in young adults. No clinical trial is obviously possible, and the only data available are environmental exposure or animal studies. This case report may help medical teams to make hard decision for a treatment of APL during pregnancy.

Autopsy findings of ectodermal dysplasia and sex development disorder in a fetus with 19q12q13 microdeletion.

A 5,6 Mb de novo 19q12-q13.12 interstitial deletion was diagnosed prenatally by array-comparative genomic hybridization in a 26 weeks male fetus presenting with intra-uterine growth retardation, left clubfoot, atypical genitalia and dysmorphic features. Autopsic examination following termination of pregnancy identified a severe disorder of sex development (DSD) including hypospadias, micropenis, bifid scrotum and right cryptorchidism associated with signs of ectodermal dysplasia: scalp hypopigmentation, thick and frizzy hair, absence of eyelashes, poorly developed nails and a thin skin with prominent superficial veins. Other findings were abnormal lung lobation and facial dysmorphism. This new case of DSD with a 19q12q13 deletion expands the phenotypic spectrum associated with this chromosomal rearrangment and suggests that WTIP is a strong candidate gene involved in male sex differentiation.

Feasibility of 2-D ultrasound shear wave elastography of fetal lungs in case of threatened preterm labour: a study protocol.

INTRODUCTION: 2-D ultrasound shear wave elastography (SWE) could be considered as a new noninvasive tool for monitoring fetal lung development based on evaluation of mechanical properties during pregnancy. Interesting results are available concerning the use of SWE on developing organs, especially on premature infants and animal models. The main objective in this study is to evaluate the feasibility of 2-D SWE in human fetal lungs between 24 and 34 weeks of gestation (WG). The secondary objective is to modellise fetal lung-to-liver elastography ratio (LLE ratio) and to assess variations between normal lung and lung surfactant-enriched after a corticosteroids course indicated for a threatened preterm labour (TPL). METHODS/DESIGN: A prospective case-control study will be performed between 24 and 34 WG. Fetal lungs and liver will be explored by SWE into two groups: fetuses of women with an uncomplicated pregnancy (control group) and fetuses of women with a TPL requiring administration of corticosteroids (cases group). LLE ratio will be defined as the value of the lung elasticity divided by the value of the liver elasticity.Primary judgement criterion is the value of elasticity modulus expressed in kilopascal. Lungs and liver will be explored through three measurements to define the most reproducible regions with the lowest intra- and inter-observer variability. Feasibility will be evaluated by assessing the number of examinations performed and the number of examinations with interpretable results. Intra- and inter-observer reproducibility will be evaluated by means of the intra-class correlation coefficient. ETHICS AND DISSEMINATION: Approval of the study protocol was obtained from the human ethical research committee (Comité de Protection des Personnes EST II, process number 15/494) and the French National Agency for Medicines and Health Products Safety (process number 2015-A01575-44). All participants will sign a statement of informed consent. TRIAL REGISTRATION NUMBER: NCT02870608; Recruiting.