Premature birth in women with increased risk of premature birth Pregnancy and Childbirth Fetus and newborn affected by maternal complications of pregnancy
Conditions
Interventions
Treatment with insertion of vaginal pessary vs expectant management. The vaginal pessary is inserted in those allocated to this group within 5 days after the 20-24+6 weeks scan. The pessary will be re
Sponsors
King's College Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 12/08/2008: 1. Women with singleton pregnancies and with a cervical length of 25 mm or less 2. Women with twin pregnancies Previous inclusion criteria: 1. Women with twin pregnancies undergoing routine ultrasonography at 20-24+6 weeks of gestation for examination of foetal anatomy and growth 2. Both foetuses are found to be alive with no major abnormalities, severe twin to twin transfusion syndrome or severe foetal growth restriction
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 12/08/2008: 1. Major foetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), foetal death, severe twin to twin transfusion syndrome or severe foetal growth restriction in one of the foetuses (in the case of twin pregnancy) diagnosed before randomisation 2. Painful regular uterine contractions, history of ruptured membranes, or prophylactic cerclage before randomisation 3. Patients who are unconscious, severely ill, mentally handicapped or under the age of 16 years Previous exclusion criteria: 1. Major foetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), or death of one or both of the foetuses, severe twin to twin transfusion syndrome diagnosed before randomisation 2. Painful regular uterine contractions, history of ruptured membranes, or prophylactic cerclage before randomisation 3. Patients who are unconscious, severely ill or mentally handicapped 4. Under the age of 16 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous delivery before 34 weeks of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Birth weight (mean, less than 2.5 kg and less than 1.5 kg) 2. Foetal or neonatal death 3. Major adverse outcomes before discharge from the hospital (intraventricular haemorrhage, respiratory distress syndrome, retinopathy of prematurity or necrotising entercolitis) 4. Need for neonatal special care (admission to a neonatal intensive care unit, ventilation, phototherapy, treatment for proven or suspected sepsis or blood transfusion). Duration of follow-up: 2 years | — |
Countries
Brazil, Chile, Colombia, Portugal, Spain, United Kingdom
Outcome results
None listed