Cervical Dilation Premature, Preterm Birth, Twin Pregnancy, Antepartum Condition or Complication
Conditions
Keywords
Cervical cerclage
Brief summary
This is a multicenter randomized study designed to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth \<34 weeks in asymptomatic women with twin gestations and dilated cervix, diagnosed by pelvic exam between 16 to 23 6/7 weeks of gestation.
Detailed description
Twin pregnancies have 58% 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. When cervical dilation is identified before 24 weeks in singleton pregnancies, the risk of preterm birth is 90%-100%; based on a small series of cases, approximately 50% of twin gestations with cervical dilation will be delivered prior to viability (24 weeks) and the risk of preterm birth prior to 34 and 37 weeks was 85% and 100%. Cervical dilation is the worst prognostic factor for preterm birth. There are a small number of case reports of cervical cerclage in twin pregnancies with a dilated cervix that suggest similar outcomes to those in singleton pregnancies. The investigators' objective is to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth \<34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and dilated cervix (1 to 5 cm) between 16 to 23 6/7 weeks of gestation.
Interventions
PROCEDUREPhysical exam indicated cerclage
Cervical cerclage
Sponsors
Columbia University
Federico II University
Albany Medical College
University of Rochester
George Washington University
Wright State University
Baystate Medical Center
Università degli Studi di Brescia
University of Bologna
University Hospital, Geneva
University of Warsaw
Maternal Fetal Medicine Associates
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 older than 18 years of age 2. Diamniotic twin pregnancy 3. Cervical dilation between 1 to 5 cm and/or visible membranes by pelvic exam or speculum exam between at 16-23 6/7 weeks gestation
Exclusion criteria
1. Singleton pregnancy or higher order than twins multiple gestation 2. Cervical dilation more than 5 cm 3. Amniotic membranes prolapsed beyond external os into the vagina, unable to visualize cervical tissue 4. More than 24 weeks of gestation 5. Multifetal reduction after 14 weeks 6. Monoamniotic twins 7. Twin-twin transfusion syndrome 8. Ruptured amniotic membranes at the time of diagnosis of dilated cervix 9. Major fetal structural anomaly 10. Fetal chromosomal abnormality 11. Cerclage already in place for other indications 12. Active vaginal bleeding 13. Suspicion of clinical or biochemical chorioamnionitis 14. Painful regular uterine contractions 15. Labor (progressing cervical dilation) 16. Placenta previa
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 |
|---|---|---|
| Spontaneous preterm birth less than 34 | at delivery | Incidence of spontaneous preterm birth less than 34 weeks |
| 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 presentation of rupture membranes | Mean value (weeks) through study completion |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chorioamnionitis | Time of delivery | Incidence |
| Interval between diagnosis and delivery | at delivery | Mean value (days) through study completion |
| 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 |
| Fetal demise | Incidence before delivery | Incidence |
| Neonatal death | Incidence between birth and 28 days of age | Incidence |
| Perinatal death | Incidence before and after birth ulntil 28 days of age | Incidence |
| Maternal death | Between birth and 6 weeks postpartum | Incidence |
Countries
Italy, Poland, United States
Outcome results
None listed