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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Cervical cerclage indicated by short cervix ≤15mm
George Washington University
Washington D.C., District of Columbia, United States
NOT_YET_RECRUITINGThomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGAustin Maternal Fetal Medicine St David's Health Care
Austin, Texas, United States
Preterm delivery less than 34 weeks
Incidence of preterm birth less than 34 weeks (any indication)
Time frame: at delivery
Spontaneous preterm birth rates
Incidence of spontaneous preterm birth less than 34 weeks
Time frame: at delivery
Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks
Incidence of preterm birth less than \<32 weeks, \<28 weeks, or \<24 weeks
Time frame: at delivery
Mean gestational age at delivery
Mean value of gestational age at delivery (weeks)
Time frame: at delivery
Birth weight at birth
Mean value (grams)
Time frame: at delivery
Gestational age at spontaneous rupture of membranes
Mean value (weeks) through study completion
Time frame: at delivery
Premature rupture of membranes
Incidence
Time frame: at delivery
Chorioamnionitis
Incidence
Time frame: at delivery
Composite adverse neonatal outcome
Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia, retinopathy, blood-culture proven sepsis
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The Egyptian IVF Center
Cairo, Egypt
RECRUITINGBologna University
Bologna, Italy
RECRUITINGUniversity of Brescia
Brescia, Italy
RECRUITINGUniversità degli Studi di Napoli "Federico II"
Naples, Italy
RECRUITINGUniversity of Barcelona
Barcelona, Spain
RECRUITINGTime frame: Incidence between birth and 28 days of age
Neonatal death
Incidence
Time frame: Between birth and 28 days of age
Maternal death
Incidence
Time frame: Between birth and 6 weeks postpartum
Interval between diagnosis and delivery
Mean value (days) through study completion
Time frame: at delivery