Physical Exam Indicated Cerclage in Twin Gestations (TWIN-PEIC)

Thomas Jefferson University

Status: Terminated

Conditions: Twin Pregnancy, Antepartum Condition or Complication; Cervical Dilation Premature; Preterm Birth

Treatments: Procedure: Physical exam indicated cerclage

Study type: Interventional

Funder types: Other

Identifiers

NCT02490384

ThomasJeffersonU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Physical exam indicated cerclage

Active Comparator group

Description:

Cerclage

Treatment:

Procedure: Physical exam indicated cerclage

Expectant management

No Intervention group

Description:

No cerclage