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APOSTEL VI

Will a cervical pessary prolong pregnancy in women who have been discharged after an episode of threatened preterm labor: a multicenter randomised trial

 

Go to the Apostel VI website.



Objective
Spontaneous preterm delivery occurs in 9% of all pregnancies and is a major cause of infant mortality and morbidity. It is known that women undelivered after hospital admission for threatened preterm labor remain at an increased risk of preterm delivery. A potential breakthrough in the prevention of preterm birth is the use of a cervical pessary. The APOSTEL-VI study will assess whether a cervical pessary prolongs pregnancy in women who have been admitted for threatened preterm labor with a positive fibronectin test, but remained undelivered. Furthermore we will study whether a cervical pessary influences neonatal outcome and re-admittance for new symptoms of preterm labor.
 
Study design

Multicenter Randomised Controlled Trial

Study population
200 pregnant women with an episode threatened preterm labour between 24+0/7 and 34+6/7weeks gestational age; with a cervical length between 5mm - 15mm or a cervical length between 15mm - 30mm and a positive fibronectin test, who remained undelivered after 48 hours and had a complete course of antenatal corticosteroids and tocolysis.

Intervention
Women with a gestational age between 26+0/7 and 34+6/7 weeks who have been admitted with threatened pre-term labour with a singleton or twin pregnancy will be eligible if undelivered after completion of one course of antenatal corticosteroids [ACS] and tocolytics for 48 hours. Women will be randomized for either a cervical pessary or for no intervention.

Outcome measures
Primary outcome is preterm delivery before 37 weeks. Secondary outcomes will be a composite neonatal outcome of morbidity and mortality. Other outcomes will be time to delivery, gestational age at delivery and re-admittance for new symptoms of preterm labour.

Power/data analysis
The analysis of the randomised clinical trial will be by intention to treat.

Time schedule
36 months

Projectgroup
Dr. E. Pajkrt, gynaecoloog AMC Amsterdam [PI]

Dr. M. Woisky, UMC St Radboud Nijmegen
Dr. K.W. Bloemenkamp  LUMC Leiden
Dr. H.C. Scheepers, MUMC+ Maastricht
Dr. B.N. Bijvank, Isala Klinieken Zwolle
Dr. C.J. Bax, VUmc, Amsterdam
Dr. M. Porath, Máxima MC Veldhoven
Dr. M. Franssen, UMCG Groningen
Dr. J.J. Duvekot, Erasmus MC Rotterdam
Dr. M. Oudijk, UMCU Utrecht

Methodology
E. Schuit, PhD epidemiologist, UMCU Utrecht

Contact (researcher)
F.J.R. Hermans, MSc, arts-onderzoeker, apostel6@studies-obsgyn.nl