Keywords: multiple pregnancy, pessary, preterm delivery, randomised clinical trial. In het Nederlands: meerlingzwangerschap, pessarium, vroeggeboorte, gerandomiseerde klinische trial
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 g
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Multiple pregnancy (monochorionic and bichorionic) between 12 and 20 weeks of gestation.
Exclusion criteria
Exclusion criteria: Women with multiple pregnancies in which at least one of the fetus(es) has major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), or death of one or both of the foetuses, as well as severe twin-to-twin transfusion syndrome diagnosed before randomization, 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. They will be measured untill 10 weeks after the expected term date. | — |
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. | — |
Contacts
Public ContactS.M.S. Liem
Postbus 22660
Outcome results
None listed