Nicolaides 2008.

Trial name or title	Randomised study of pessary vs standard management in women with increased chance of premature birth.
Methods	Multicentre, randomised, open‐label trial.
Participants	Women with singleton pregnancies and with a cervical length of 25 mm or less. Women with twin pregnancies.
Interventions	Vaginal pessary (CE0482, MED/CERT ISO 9003 / EN 46003) versus standard management.
Outcomes	Primary outcome Spontaneous delivery from randomisation to 33 weeks and 6 days (237 days) of gestation. Seconday outcomes Low birthweight. Fetal or neonatal death. Major adverse outcomes (IVH, RDS, retinopathy of prematurity or necrotising enterocolitis). Need for neonatal special care (ventilation, phototherapy, treatment for sepsis, blood transfusion).
Starting date	.
Contact information	Prof, Kypros Nicolaides Tel: +442032999000 ext.: 8256 kypros@fetalmedicine.com
Notes	ISRCTN01096902.