Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length:the Quadruple P randomised controlled trial

Background: Preterm birth is in quantity and in severity the most important topic in obstetric care in the developed world. Progestogens and cervical pessaries have been studied as potential preventive treatments with conflicting results. So far, no study has compared both treatments. Methods/design: The Quadruple P study aims to compare the efficacy of vaginal progesterone and cervical pessary in the prevention of adverse perinatal outcome associated with preterm birth in asymptomatic women with a short cervix, in singleton and multiple pregnancies separately. It is a nationwide open-label mu... Mehr ...

Verfasser: van Zijl, Maud D.
Koullali, Bouchra
Naaktgeboren, Christiana A.
Schuit, Ewoud
Bekedam, Dick J.
Moll, Etelka
Oudijk, Martijn A.
van Baal, Wilhelmina M.
de Boer, Marjon A.
Visser, Henricus
van Drongelen, Joris
van de Made, Flip W.
Vollebregt, Karlijn C.
Muller, Moira A.
Bekker, Mireille N.
Brons, Jozien T. J.
Sueters, Marieke
Langenveld, Josje
Franssen, Maureen T.
Schuitemaker, Nico W.
van Beek, Erik
Scheepers, Hubertina C. J.
de Boer, Karin
Tepe, Eveline M.
Huisjes, Anjoke J. M.
Hooker, Angelo B.
Verheijen, Evelyn C. J.
Papatsonis, Dimitri N.
Mol, Ben Willem J.
Kazemier, Brenda M.
Pajkrt, Eva
Dokumenttyp: Artikel
Erscheinungsdatum: 2017
Reihe/Periodikum: van Zijl , M D , Koullali , B , Naaktgeboren , C A , Schuit , E , Bekedam , D J , Moll , E , Oudijk , M A , van Baal , W M , de Boer , M A , Visser , H , van Drongelen , J , van de Made , F W , Vollebregt , K C , Muller , M A , Bekker , M N , Brons , J T J , Sueters , M , Langenveld , J , Franssen , M T , Schuitemaker , N W , van Beek , E , Scheepers , H C J , de Boer , K , Tepe , E M , Huisjes , A J M , Hooker , A B , Verheijen , E C J , Papatsonis , D N , Mol , B W J , Kazemier , B M & Pajkrt , E 2017 , ' Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length : the Quadruple P randomised controlled trial ' , BMC Pregnancy and Childbirth , vol. 17 , 284 . https://doi.org/10.1186/s12884-017-1454-x
Schlagwörter: Preterm birth / Singletons / Multiples / Prevention / Pessary / Progesterone / MULTIPLE PREGNANCIES / BIRTH / SINGLETON / NETHERLANDS / MULTICENTER / RISK
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-29187183
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://cris.maastrichtuniversity.nl/en/publications/8482c33f-edfc-4f68-9c0d-1c910cda04cb

Background: Preterm birth is in quantity and in severity the most important topic in obstetric care in the developed world. Progestogens and cervical pessaries have been studied as potential preventive treatments with conflicting results. So far, no study has compared both treatments. Methods/design: The Quadruple P study aims to compare the efficacy of vaginal progesterone and cervical pessary in the prevention of adverse perinatal outcome associated with preterm birth in asymptomatic women with a short cervix, in singleton and multiple pregnancies separately. It is a nationwide open-label multicentre randomized clinical trial (RCT) with a superiority design and will be accompanied by an economic analysis. Pregnant women undergoing the routine anomaly scan will be offered cervical length measurement between 18 and 22 weeks in a singleton and at 16-22 weeks in a multiple pregnancy. Women with a short cervix, defined as less than, or equal to 35 mm in a singleton and less than 38 mm in a multiple pregnancy, will be invited to participate in the study. Eligible women will be randomly allocated to receive either progesterone or a cervical pessary. Following randomization, the silicone cervical pessary will be placed during vaginal examination or 200 mg progesterone capsules will be daily self-administered vaginally. Both interventions will be continued until 36 weeks gestation or until delivery, whichever comes first. Primary outcome will be composite adverse perinatal outcome of perinatal mortality and perinatal morbidity including bronchopulmonary dysplasia, intraventricular haemorrhage grade III and IV, periventricular leukomalacia higher than grade I, necrotizing enterocolitis higher than stage I, Retinopathy of prematurity (ROP) or culture proven sepsis. These outcomes will be measured up until 10 weeks after the expected due date. Secondary outcomes will be, among others, time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, admission to neonatal intensive care unit, maternal morbidity, ...