Twin Pregnancy With Antenatal Problem, Preterm Birth, Short Cervix
Conditions
Brief summary
This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth \<34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.
Detailed description
Twin pregnancies have 59% incidence of preterm delivery (before 37 weeks of gestation), with increased perinatal mortality and neonatal morbidity. No therapy has proven effective in preventing preterm birth in twins. The transvaginal cervical length (TVCL) performed before 24 weeks have been determined to be the best tool to identified women with twin pregnancy at risk of preterm birth (PTB). When short TVCL is identified before 24 weeks, the risk of preterm birth is 60%-70% for TVCL ≤25mm and 80%-90% for TVCL ≤15mm. There are a small number of case reports of cervical cerclage in twin pregnancies with cervical length ≤15mm that suggest decreased preterm birth by 80%. The investigators' objective is to determine if ultrasound indicated cerclage in reduces the incidence of spontaneous preterm birth \<34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and cervical length ≤15mm between 16 to 23 6/7 weeks of gestation.
Interventions
PROCEDURECervical cerclage
Cervical cerclage indicated by short cervix ≤15mm
Sponsors
Federico II University
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Pregnant women more than 18 years of age (limits the participants to female gender) 2. Diamniotic twin pregnancy 3. Asymptomatic 4. Transvaginal cervical length ≤ 15 mm between 16-23 6/7 weeks gestation
Exclusion criteria
1. Singleton or higher order than twins multiple gestation 2. Transvaginal cervical length \>15mm 3. Cervical dilation with visible amniotic membranes 4. Amniotic membranes prolapsed into the vagina 5. Fetal reduction after 14 weeks form higher order 6. Monoamniotic twins 7. Twin-twin transfusion syndrome 8. Ruptured membranes 9. Major fetal structural anomaly 10. Fetal chromosomal abnormality 11. Cerclage already in place for other indication 12. Active vaginal bleeding 13. Clinical chorioamnionitis 14. Placenta previa 15. Painful regular uterine contractions 16. Labor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preterm delivery less than 34 weeks | at delivery | Incidence of preterm birth less than 34 weeks (any indication) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks | at delivery | Incidence of preterm birth less than \<32 weeks, \<28 weeks, or \<24 weeks |
| Mean gestational age at delivery | at delivery | Mean value of gestational age at delivery (weeks) |
| Birth weight at birth | at delivery | Mean value (grams) |
| Gestational age at spontaneous rupture of membranes | at delivery | Mean value (weeks) through study completion |
| Premature rupture of membranes | at delivery | Incidence |
| Spontaneous preterm birth rates | at delivery | Incidence of spontaneous preterm birth less than 34 weeks |
| Composite adverse neonatal outcome | Incidence between birth and 28 days of age | Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia, retinopathy, blood-culture proven sepsis |
| Neonatal death | Between birth and 28 days of age | Incidence |
| Maternal death | Between birth and 6 weeks postpartum | Incidence |
| Interval between diagnosis and delivery | at delivery | Mean value (days) through study completion |
| Chorioamnionitis | at delivery | Incidence |
Countries
Egypt, Italy, Spain, United States
Contacts
Primary ContactAmanda Roman, MD
Outcome results
None listed