preventing preterm birth with progesterone costs and effects of screening low risk women with a singleton pregnancy for short cervical length, the triple p study预防早产与孕激素筛查的成本和影响低风险的女性一个单例妊娠,宫颈长度短,三p研究.pdfVIP

van Os et al. BMC Pregnancy and Childbirth 2011, 11:77 /1471-2393/11/77 STUDY PROTOCOL Open Access Preventing preterm birth with progesterone: costs and effects of screening low risk women with a singleton pregnancy for short cervical length, the Triple P study Melanie A van Os1*, Jeanine A van der Ven2†, C Emily Kleinrouweler2†, Eva Pajkrt2†, Esteriek de Miranda2†, Aleid van Wassenaer3†, Martina Porath4†, Patrick M Bossuyt5†, Kitty WM Bloemenkamp6†, Christine Willekes7†, Mallory Woiski8†, Martijn A Oudijk9†, Katia M Bilardo10†, Marko J Sikkema11†, Johannes J Duvekot12†, Diederik Veersema13†, Jacqueline Laudy14†, Petra Kuiper15†, Christianne JM de Groot1†, Ben Willem J Mol2† and Monique C Haak6† Abstract Background: Women with a short cervical length in mid-trimester pregnancy have a higher risk of preterm birth and therefore a higher rate of neonatal mortality and morbidity. Progesterone can potentially decrease the number of preterm births and lower neonatal mortality and morbidity. Previous studies showed good results of progesterone in women with either a history of preterm birth or a short cervix. However, it is unknown whether screening for a short cervix and subsequent treatment in mid trimester pregnancy is effective in low risk women. Methods/Design: We plan a combined screen and treat study among women with a singleton pregnancy without a previous preterm birth. In these women, we will measure cervical length at the standard anomaly scan performed between 18 and 22 weeks. Women with cervical length ≤ 30 mm at two independent measurements will be randomly allocated to receive either vaginal progesterone tablets or placebo between 22 and 34 weeks. The primary outcome of this trial is adverse neonatal condition, defined as a composite outcome of neonatal mortality and severe morbidity. Secondary ou