Cervical Cerclage for Preventing Spontaneous Preterm Birth in Twin Pregnancies With Transvaginal Ultrasound Cervical Length ≤ 15mm: a Study Protocol for a Randomized Clinical Trial
| Registry | NCT03340688, acronym TWIN-UIC |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 200 (Estimated) |
| Sponsor | Thomas Jefferson University (Other); collaborators: Federico II University |
| Conditions | Twin Pregnancy With Antenatal Problem, Preterm Birth, Short Cervix |
| Interventions | Cervical cerclage (Procedure) |
| Dates | start 2017-06-22, primary completion 2024-06-01 (estimated), completion 2025-06-01 (estimated), first posted 2017-11-13, last updated 2020-04-27 |
| Locations | 8 sites in United States, Egypt, Italy, Spain |
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All trials for Twin Pregnancy With Antenatal Problem All trials for Preterm Birth All trials of Cervical cerclage
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cervical cerclage + vaginal progesterone | Active comparator | Procedure: Cervical cerclage | Cervical cerclage in twin pregnancy with transvaginal cervical length ≤15mm and Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks |
| Vaginal progesterone | No intervention | Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks |
Sex: Female, ages: 18 Years to 60 Years
Inclusion Criteria: 1. Pregnant women more than 18 years of age (limits the participants to female gender) 2. Diamniotic twin pregnancy 3. Asymptomatic 4. Transvaginal cervical length ≤ 15 mm between 16-23 6/7 weeks gestation Exclusion Criteria: 1. Singleton or higher order than twins multiple gestation 2. Transvaginal cervical length >15mm 3. Cervical dilation with visible amniotic membranes 4. Amniotic membranes prolapsed into the vagina 5. Fetal reduction after 14 weeks form higher order 6. Monoamniotic twins 7. Twin-twin transfusion syndrome 8. Ruptured membranes 9. Major fetal structural anomaly 10. Fetal chromosomal abnormality 11. Cerclage already in place for other indication 12. Active vaginal bleeding 13. Clinical chorioamnionitis 14. Placenta previa 15. Painful regular uterine contractions 16. Labor
| Facility | City | Country | Status |
|---|---|---|---|
| George Washington University | Washington D.C., District of Columbia | United States | Not yet recruiting |
| Thomas Jefferson University Hospital | Philadelphia, Pennsylvania | United States | Recruiting |
| Austin Maternal Fetal Medicine St David's Health Care | Austin, Texas | United States | Recruiting |
| The Egyptian IVF Center | Cairo | Egypt | Recruiting |
| Bologna University | Bologna | Italy | Recruiting |
| University of Brescia | Brescia | Italy | Recruiting |
| Università degli Studi di Napoli "Federico II" | Naples | Italy | Recruiting |
| University of Barcelona | Barcelona | Spain | Recruiting |