Trials / Terminated
TerminatedNCT02490384
Physical Exam Indicated Cerclage in Twin Gestations
Randomized Control Trial Physical Exam Indicated Cerclage in Twin Gestations
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Thomas Jefferson University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Physical exam indicated cerclage | Cervical cerclage |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2019-12-01
- Completion
- 2019-12-12
- First posted
- 2015-07-03
- Last updated
- 2020-04-27
Locations
11 sites across 3 countries: United States, Italy, Poland
Source: ClinicalTrials.gov record NCT02490384. Inclusion in this directory is not an endorsement.