Suchergebnisse

Maud D van Zijl,1 Bouchra Koullali,1 Ben WJ Mol,2 Eva Pajkrt,1 Martijn A Oudijk1 1Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, the Netherlands; 2The Robinson Research Institute, School for Reproductive Health and Pediatrics, University of Adelaide, Adelaide, SA, Australia Abstract: Preterm birth (PTB), defined as delivery at <37 weeks of gestation, is the most important cause of neonatal morbidity and mortality. Therefore, preventing PTB is one of the main goals in obstetric care. In this review, we provide an overview of the current available literature on screening for risk factors for PTB and a summary of preventive strategies in both low-risk and high-risk women with singleton or multiple gestations. Furthermore, current challenges and future prospects on PTB are discussed. For an optimal prevention of PTB, risk stratification should be based on a combination of (maternal) risk factors, obstetric history, and screening tools. Cervical length measurements can help identify women at risk. Thereafter, preventive strategies such as progesterone, pessaries, and cerclage may help prevent PTB. Effective screening and prevention of PTB vary between the different pregnancy populations. In singleton or multiple pregnancies with a short cervix, without previous PTB, a pessary or progesterone might prevent PTB. In women with a (recurrent) PTB in the past, progesterone and a cerclage may prevent recurrence. The effect of a pessary in these high-risk women is currently being studied. A strong collaboration between doctors, patients' organizations, pharmaceutical companies, and (international) governments is needed to reduce the morbidity and mortality as a result of spontaneous PTB. Keywords: preterm birth, prevention, risk factors, current challenges, future prospectsA Letter to the Editor has been received and published for this article.

Preterm birth (PTB), defined as delivery at <37 weeks of gestation, is the most important cause of neonatal morbidity and mortality. Therefore, preventing PTB is one of the main goals in obstetric care. In this review, we provide an overview of the current available literature on screening for risk factors for PTB and a summary of preventive strategies in both low-risk and high-risk women with singleton or multiple gestations. Furthermore, current challenges and future prospects on PTB are discussed. For an optimal prevention of PTB, risk stratification should be based on a combination of (maternal) risk factors, obstetric history, and screening tools. Cervical length measurements can help identify women at risk. Thereafter, preventive strategies such as progesterone, pessaries, and cerclage may help prevent PTB. Effective screening and prevention of PTB vary between the different pregnancy populations. In singleton or multiple pregnancies with a short cervix, without previous PTB, a pessary or progesterone might prevent PTB. In women with a (recurrent) PTB in the past, progesterone and a cerclage may prevent recurrence. The effect of a pessary in these high-risk women is currently being studied. A strong collaboration between doctors, patients' organizations, pharmaceutical companies, and (international) governments is needed to reduce the morbidity and mortality as a result of spontaneous PTB.

Investigator-initiated clinical trials are crucial for improving quality of care for children and pregnant women as they are often excluded from industry-initiated trials. However, trials have become increasingly time-consuming and costly since the EU Clinical Trial Directive entered into force in 2001. This directive made compliance with ICH-Good Clinical Practice Guidelines (ethical and quality standard for conducting human subject research) mandatory for all clinical trials, regardless of its risk-classification. By discussing two investigator-initiated, 'low-risk' drug trials, we aim to illustrate that compliance with all GCP requirements makes trials very laborious and expensive, while a clear rationale is missing. This discourages clinical researchers to start and carry out investigator-initiated research. However, the forthcoming EU Clinical Trial Regulation (No 536/2014) seems to provide a solution as it allows for less stringent rules for low-risk trials. We want to raise awareness for these developments in both the clinical research community and the European and national regulatory authorities. Implementation of this forthcoming Regulation regulatory policies should be done in such a way that investigator-initiated trials evaluating standard care interventions will become more feasible. This will allow us to obtain evidence on optimal and safe treatments, especially for groups that are underrepresented in medical research.