multiple pregnancy preterm birth
Conditions
Interventions
Eligible women will be randomly allocated to receive either a cervical pessary
or no intervention. The cervical pessary will be placed in situ at 16 to 20
weeks, and will stay in situ up to 36 weeks
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All women presenting with a multiple pregnancy (monochorionic and bichorionic) between 12 and 20 weeks of gestation are eligible for the study
Exclusion criteria
Exclusion criteria: Women with multiple pregnancies in which at least one of the fetus(es) has major congenital anomalies known at study entry will not be included
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome parameter is the composite morbidity rate of children in the two groups. This composite morbidity rate contains the following variables: severe Respiratory Distress Syndrome (RDS), Broncho Pulmonal Dysplasia (BPD), Intraventricular Haemorrhage II B or worse, Necrotizing Enterocolitis (NEC), proven sepsis and death before discharge from the nursery (6). They will be measured until 6 weeks after the date of delivery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. At present, a longer follow-up is not planned. | — |
Countries
Netherlands
Outcome results
None listed