 Screening for spontaneous preterm birth in singleton pregnancies. TÉMAKIÍRÁS Intézmény: Semmelweis Egyetem gyógyszerészeti tudományok Semmelweis Egyetem Doktori Iskola témavezető: Benkő Zsófia helyszín (magyar oldal): Semmelweis Egyetem helyszín rövidítés: SE A kutatási téma leírása: 1. Introduction 1.1 Background and Rationale Prematurity is one of the most common complication in singleton and twin pregnancies worldwide. It effects 10 percent of pregnant women. Prematurity can happen spontaneously and also often due to iatrogenic reasons, mostly due to hypertensive disorders, such as preeclampsia (PE) or fetal growth restriction (FGR). Screening for these conditions has become one of the most studied challenges of obstetrics worldwide as therapy is often limited, therefore prediction and prevention is crucial. There have been great efforts worldwide to develop screening strategies, however we all know that ethnical and geographical factors should be taken into account as well. 1.2 Objectives The aim of the study is to examine the performance of the widely studied thesis on that cervical length measurement at around 20 weeks in combination with the medical history is the most reliable predictor for spontaneous preterm birth. Our aim is to demonstrate that this method would be useful in Hungarian university hospitals, and collect data of pregnant women and follow up their pregnancies, to validate international methods for screening. Prediction of spontaneous preterm birth A combined screening model of cervical length measured at 18-22 weeks` and obstetric history provides a good prediction of spontaneous preterm birth than either factor alone. 1 Vaginal progesterone reduces the risk of preterm birth and neonatal morbidity and mortality in women with a singleton gestation and a mid-trimester CL ≤25 mm, without any deleterious effects on neurodevelopmental outcome. 2 This is a prospective cohort study in Semmelweis University Department of Obstetric and Gynaecology. To achieve results representative of what would happen in practice, a single gate multicentre prospective, cohort study of 3000 pregnancies in our two departments will be undertaken in 2 years. Training of healthcare professionals in participating centres: We will undertake training for recording properly maternal history and measurement of the cervical length to achieve reliable data. Clinical evaluation of new screening method: All eligible women attending for their routine second trimester scan (18-21 weeks’) will be invited to participate. The maternal history will be recorded and apart from the routine measurements cervical length will be measured according to standard protocol. 2. Methods 2.1. Eligibility Criteria Participant selection There will be NO EXCEPTIONS (waivers) to eligibility requirements at the time of recruitment. Questions about eligibility criteria should be addressed PRIOR to attempting to recruit the participant. The eligibility criteria for this project have been carefully considered and are the standards used to ensure that only medically appropriate participants are entered. Participants not meeting the criteria should not be entered into the study. It is therefore vital that exceptions are not made to these eligibility criteria. Participants will be considered eligible for enrolment in this study if they fulfil all the inclusion criteria and none of the exclusion criteria as defined below. Participant Inclusion Criteria • Age > 18 years; • Live fetus at 18-22 weeks of gestation; Participant Exclusion Criteria • Women who are unconscious or severely ill, those with learning difficulties or serious mental illness. • Multiple gestation. • Pregnancies complicated by major fetal abnormality. • Pregnant women on Progesterone • Pregnant women that have cerclage inserted. Eligibility Criteria for Individuals Performing the Interventions Both centres involved in the data collection will have staff who are appropriately trained in obstetric ultrasound and possess certificates of competence for non-routine measurements. 2.2 Participant Timeline Routine screening visit at 19-21weeks • Participant demographics, medical and obstetric history • Measurement of weight • Routine fetal scan • Measurement of cervical length transvaginally as per FMF protocol • Measurement of UTPI • Concomitant medication Follow up phone call • Collect outcome of the pregnancy 2.3 Outcomes Primary Outcomes The primary outcome will be to record the incidence of spontaneous preterm birth (delivery before 36+6weeks’) to demonstrate in non-selected Hungarian population that the measurement of the cervical length and recording medical history at 18-22 weeks, is useful to identify high risk women for spontaneous preterm birth, therefore the method could be implemented in the national guidelines. Secondary Outcomes Secondary outcome measures: • The incidence of spontaneous and iatrogenic preterm birth between 24+0 and 27+6 weeks’ gestation, 29+6 weeks, 31+6 weeks, 33+6 weeks, 36+6; • Incidence of stillbirth or neonatal death due to any cause; • Incidence of PE, gestational hypertension; • Incidence of fetal growth restriction; • Incidence of fetal defects; • Incidence of birth weight below the 3rd, 5th and 10th percentile; • Neonatal morbidity - Major adverse outcomes before discharge from the hospital • Intraventricular haemorrhage (grade II or above), • Respiratory distress syndrome (requiring ventilation and surfactant), • Retinopathy of prematurity • Necrotising entercolitis (requiring surgical intervention) • Neonatal sepsis (confirmed by bacteraemia in cultures) • Neonatal anaemia (low haemoglobin requiring blood transfusion) • Composite of any of the above • Neonatal therapy • Admission to neonatal intensive care unit • Ventilation – Defined as need of positive pressure (continuous positive airway pressure [CPAP] or nasal continuous positive airway pressure [NCPAP]) or intubation • Composite of any of the above Collection of pregnancy and neonatal outcomes Data on pregnancy outcome will be collected from hospital maternity records or from patients. The obstetric records of all participants delivered at <37 weeks will be examined to determine if the preterm birth is iatrogenic or spontaneous. The latter includes those with spontaneous onset of labour and those with preterm pre-labour rupture of membranes. Literature 1. Celik, E., To, M., Gajewska, K., Smith, G. C. S. & Nicolaides, K. H. Cervical length and obstetric history predict spontaneous preterm birth: Development and validation of a model to provide individualized risk assessment. Ultrasound in Obstetrics and Gynecology 31, 549–554 (2008). 2. Romero, R. et al. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data. Ultrasound in Obstetrics Jelentkezési határidő: 2024-09-30 |