An interventional study of Physical exam indicated cerclage in Twin Pregnancy, Antepartum Condition or Complication, Preterm Birth and Cervical Dilation Premature, sponsored by Thomas Jefferson University. Terminated at 11 sites in 3 countries. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-04-27.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Treatment
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.
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 30 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
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Exclusion Criteria:
Cerclage
Procedure: Physical exam indicated cerclage
No cerclage
Cervical cerclage
Preterm delivery less than 34 weeks
Incidence of preterm birth less than 34 weeks (any indication)
Time frame: at delivery
Spontaneous preterm birth less than 34
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 presentation of rupture membranes
Chorioamnionitis
Incidence
Time frame: Time of delivery
Composite adverse neonatal outcome
Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia, retinopathy, blood-culture proven sepsis
Time frame: Incidence between birth and 28 days of age
Fetal demise
Incidence
Time frame: Incidence before delivery
Neonatal death
Incidence
Time frame: Incidence between birth and 28 days of age
Perinatal death
Incidence
Time frame: Incidence before and after birth ulntil 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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De identified data
Supporting information: Study protocol, Sap, Csr
This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Thomas Jefferson University