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96 active trials for Preterm Birth

Clinical Grade MIS Device for Cervical Assessment to Predict Preterm Birth

Every year, globally, about 15 million babies are born preterm (before 37 weeks). This number is rising. Preterm birth (PTB) complications are the leading cause of death among children under 5 years of age, responsible for nearly 1 million deaths annually. PTB poses a strain on scarce health resources: each very premature baby costs tens of thousands of pounds in newborn care. One in 4 babies born before 28 weeks develop neurological impairment, a parent often having to give up work to care for an affected child. The prediction and prevention of PTB remain challenging because current methods, such as measuring the cervix by ultrasound, have limited accuracy. If a technique that reliably predicts PTB could be developed, there are care measures that can be employed to delay birth to reduce long-term disability/impairment. The Investigators have been studying whether they can detect the changes in cervical tissue structure and composition that precede PTB by using very low current Electrical Impedance Spectroscopy (EIS). Evidence recently showed that women at high risk of PTB (history of previous PTB), who deliver preterm, including delivery before 28 weeks gestation, have lower cervical "resistance" in mid-pregnancy than those who deliver at term. With NIHR funding, the investigators have developed a new device, based on a technique called magnetic impedance spectroscopy (MIS) that should address limitations of the EIS device for assessing PTB risk. The investigators now want to refine the new MIS device by minimising the signals it receives from other tissues around the cervix and making its measurements at internal body temperature more stable. The researchers also conduct clinical experiments to test whether it predicts PTB better than the previous EIS device, and check whether pregnant women find its use acceptable. This information will allow them to obtain UK regulatory approval to test the device in larger trials.

Start: May 2018
Progesterone to Prevent Preterm Delivery

Preterm birth (PTB) is a major challenge to perinatal health. It is defined as delivery before 37 completed gestational weeks. It accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities, and it is the second most common cause of death in children under the age of 5 year. Neonates born preterm are at risk of respiratory distress syndrome, chronic lung disease, retinopathy of prematurity, necrotizing enterocolitis, intraventricular haemorrhage and sepsis in the short term, as well as cerebral palsy, motor and sensory impairment, learning difficulties, and increased risk of chronic disease in long run. It is estimated that the societal cost of PTB is $26 billion annually in the USA alone. Until now, prevention or reduction of PTB is based on identification of risk factors in obstetrical history, biochemical markers and short cervix. History of PTB and asymptomatic short cervix at the second trimester are both strong predictors for PTB. In women with asymptomatic short cervix at the second trimester, vaginal progesterone could effectively reduce PTB. Universal cervical length screening followed by treatment with vaginal progesterone has been shown to be the most cost effective strategy in preventing PTB. These findings were confirmed in meta-analysis. Nevertheless, only minority of women may benefit from progesterone treatment if it was being started at the second trimester. There is still a large proportion of PTB, which is currently not preventable, and the current approach to prevent PTB is far from ideal. One possible hypothesis is that the initiation of progesterone treatment would be too late for its effect to take place. Therefore, we decide to use oral progesterone in the current study. The objective of the study is to determine whether early use of progesterone can prevent PTB better when compared with universal screening of cervical length and followed by treatment with progesterone in those with short cervix.

Start: January 2019