Background
Spontaneous pregnancy loss and implantation failure after assisted reproductive technologies (ART) are very common occurrences. Although 50–60% of all cases remains unexplained, various predisposing factors, including thrombophilias, have been identified. Thus, the potential benefit of a prophylaxis with low-molecular-weight heparins in improving outcomes has been often investigated over the years. However, the majority of studies are observational and results from randomized clinical trials (RCTs) are inconclusive, probably due to heterogeneity and limited sample size. To cover these unmet needs and to have further data mainly based on the real-life clinical management, we designed these multicenter registries.
Methods
OTTILIA (Observational sTudy on antiThrombotic prevention in thrombophILIA and pregnancy loss) and FIRST (recurrent Failures in assIsted Reproductive Techniques) registries are two prospective, multicenter, observational studies to evaluate pregnancy or ART outcomes in consecutive women with previous reproductive failures after spontaneous or assisted conception, respectively. All enrolled women are observed from their first visit after positive pregnancy test (OTTILIA) or before commencing a new ART cycle (FIRST) until the end of pregnancy or ART procedure (negative pregnancy test/end of pregnancy, if successful cycle), respectively. Data are collected by means of questionnaires and recorded in a central database. Follow-up investigations are performed during hospital stay, routine clinical follow-up visits or telephone interviews. Primary outcome is live birth rate in the OTTILIA register and clinical pregnancy rate in the FIRST.
Discussion
Although RCTs are the ‘gold standard’ for evaluating treatment outcomes, we believe that our registries represent a valid alternative in improving knowledge on mechanisms involved in reproductive failures and supporting future clinical decisions.
Trial registration
NCT 02385461
, retrospectively registered 5 March 2015 (OTTILIA);
NCT 02685800
, registered 10 February 2016 (FIRST).
In this study, we demonstrated that combined spinal-epidural analgesia influences the duration of the second stage of labor and the initial progression and rotation of the fetal head through the birth canal, but not the kind of delivery. A correlation between Angle of Progression values and success in the application of a vacuum has been reported by other authors and confirmed in our study.
In 2018 a 30-year-old, second gravida, was referred to the Department of Obstetrics, Ospedale San Giovanni Calibita, Fatebenefratelli, tertiary care Centre of Rome, for fetal AV block at 35 weeks of gestation.Autoimmune screening was performed and it revealed positivity to anti La/SS-A, anti-ANA, anti-RNP, anti-SM. She was not assuming corticosteroids.Previous ultrasounds revealed at the first trimester screening an increased Nuchal Translucency and in the second trimester a IIdegree AV block.
Objectives: Evaluate the relevance of the first trimester ultrasound in the early study of fetal morphology, identify the different types of fetal malformations and specify what to do with this screening examination. Methods: Our study is descriptive retrospective conducted over a period of three years, from January 2018 to December 2020. It was carried out at the obstetric gynecology department at the hospital of Nabeul. This study was conducted on 30 cases of birth defects diagnosed by ultrasound in the first trimester of pregnancy.
Results:The average maternal age of the patients was 30 years old. The mean gestational age was two and the average parity was one. Consanguinity was found in 24% of cases. The average anomaly finding was 12 GW. Central nervous system malformations were the most common. Abdomen abnormalities were the second most prevalent 25%. All cases were indicated for medical termination of pregnancy. They were discussed in multidisciplinary staff, with prior free and informed consent from the patients. Conclusions: The antenatal diagnosis of malformations is usually done at the end of the second quarter, judged late compared to literature. Qualified staff, good quality ultrasound systems, and a multidisciplinary approach are needed to improve the timeliness of diagnosis. Furthermore, the management often poses a problem of medical ethics requiring the use of a bioethics committee.
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