Preterm Birth
Conditions
Brief summary
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.
Interventions
DEVICEDevice: Silicon ring (Arabin Pessary)
Placement of a silicon pessary in the vagina, around the cervix.
Sponsors
Maternal-Infantil Vall d´Hebron Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Minimal age of 18 years * Episode of threatened preterm labour
Exclusion criteria
* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap) * Spontaneous rupture of membranes at the time of randomization * Cervical cerclage in situ * Active vaginal bleeding * Placenta previa Sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous delivery before 34 completed weeks | Each 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Fetal-Neonatal Death | Each 6 months |
| Neonatal morbidity | Each 6 months |
| Maternal adverse effects | Each 6 months |
| Birth weight | Each 6 months |
| Rupture of membranes before 34 weeks | Each 6 months |
| Hospitalisation for threatened preterm labour | Each 6 months |
| Preterm birth before 37 weeks or 28 weeks | Each 6 months |
Countries
Spain
Outcome results
None listed