Clinical trial NCT02490384: Physical Exam Indicated Cerclage in Twin Gestations
Official title: Randomized Control Trial Physical Exam Indicated Cerclage in Twin Gestations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Twin Pregnancy, Antepartum Condition or Complication
Preterm Birth
Cervical Dilation Premature
Keywords: Cervical cerclage
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Federico II University
name: Albany Medical College
name: University of Rochester
name: George Washington University
name: Wright State University
name: Baystate Medical Center
name: Università degli Studi di Brescia
name: University of Bologna
name: University Hospital, Geneva
name: University of Warsaw
name: Maternal Fetal Medicine Associates
First posted: 2015-07-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Preterm delivery less than 34 weeks
timeFrame: at delivery
Secondary outcomes:
measure: Spontaneous preterm birth less than 34
timeFrame: at delivery
measure: Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks
timeFrame: at delivery
measure: Mean gestational age at delivery
timeFrame: at delivery
measure: Birth weight at birth
timeFrame: at delivery
measure: Gestational age at spontaneous rupture of membranes
timeFrame: at presentation of rupture membranes
Other outcomes:
measure: Chorioamnionitis
timeFrame: Time of delivery
measure: Composite adverse neonatal outcome
timeFrame: Incidence between birth and 28 days of age
measure: Fetal demise
timeFrame: Incidence before delivery
measure: Neonatal death
timeFrame: Incidence between birth and 28 days of age
measure: Perinatal death
timeFrame: Incidence before and after birth ulntil 28 days of age
measure: Maternal death
timeFrame: Between birth and 6 weeks postpartum
measure: Interval between diagnosis and delivery
timeFrame: at delivery
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Dayton
country: United States
facility: Wright State University
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Austin Maternal Fetal Medicine St David's Health Care
state: Texas
city: Bologna
country: Italy
facility: Bologna University
city: Brescia
country: Italy
facility: University of Brescia
city: Naples
country: Italy
facility: Università degli Studi di Napoli "Federico II"
city: Warsaw
country: Poland
facility: University of Warsaw
Study officials:
affiliation: amanda.roman@jefferson.edu
name: Amanda Roman, MD
role: PRINCIPAL_INVESTIGATOR
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