TY - JOUR
T1 - Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length
T2 - the Quadruple P randomised controlled trial
AU - van Zijl, Maud D.
AU - Koullali, Bouchra
AU - Naaktgeboren, Christiana A.
AU - Schuit, Ewoud
AU - Bekedam, Dick J.
AU - Moll, Etelka
AU - Oudijk, Martijn A.
AU - van Baal, Wilhelmina M.
AU - de Boer, Marjon A.
AU - Visser, Henricus
AU - van Drongelen, Joris
AU - van de Made, Flip W.
AU - Vollebregt, Karlijn C.
AU - Muller, Moira A.
AU - Bekker, Mireille N.
AU - Brons, Jozien T. J.
AU - Sueters, Marieke
AU - Langenveld, Josje
AU - Franssen, Maureen T.
AU - Schuitemaker, Nico W.
AU - van Beek, Erik
AU - Scheepers, Hubertina C. J.
AU - de Boer, Karin
AU - Tepe, Eveline M.
AU - Huisjes, Anjoke J. M.
AU - Hooker, Angelo B.
AU - Verheijen, Evelyn C. J.
AU - Papatsonis, Dimitri N.
AU - Mol, Ben Willem J.
AU - Kazemier, Brenda M.
AU - Pajkrt, Eva
PY - 2017/9/4
Y1 - 2017/9/4
N2 - 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, maternal admission days for threatened preterm labour and costs. (Continued on next page)Discussion: This trial will provide evidence on whether vaginal progesterone or a cervical pessary is more effective in decreasing adverse perinatal outcome in both singletons and multiples.
AB - 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, maternal admission days for threatened preterm labour and costs. (Continued on next page)Discussion: This trial will provide evidence on whether vaginal progesterone or a cervical pessary is more effective in decreasing adverse perinatal outcome in both singletons and multiples.
KW - Preterm birth
KW - Singletons
KW - Multiples
KW - Prevention
KW - Pessary
KW - Progesterone
KW - MULTIPLE PREGNANCIES
KW - BIRTH
KW - SINGLETON
KW - NETHERLANDS
KW - MULTICENTER
KW - RISK
U2 - 10.1186/s12884-017-1454-x
DO - 10.1186/s12884-017-1454-x
M3 - Article
C2 - 28870155
SN - 1471-2393
VL - 17
JO - BMC Pregnancy and Childbirth
JF - BMC Pregnancy and Childbirth
M1 - 284
ER -