Cerclage for Twins With Short Cervical Length ≤ 15mm

Not Applicable

Recruiting

• Conditions: Twin Pregnancy With Antenatal Problem; Short Cervix; Preterm Birth
• Interventions: Procedure: Cervical cerclage

• Registration Number: NCT03340688
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-06-22
• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-27
• Primary Completion: 2024-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical cerclage + vaginal progesterone	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

Primary Outcome Measures

Name	Time	Method
Preterm delivery less than 34 weeks	at delivery	Incidence of preterm birth less than 34 weeks (any indication)

Secondary Outcome Measures

Name	Time	Method
Interval between diagnosis and delivery	at delivery	Mean value (days) through study completion
Neonatal death	Between birth and 28 days of age	Incidence
Spontaneous preterm birth rates	at delivery	Incidence of spontaneous preterm birth less than 34 weeks
Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks	at delivery	Incidence of preterm birth less than \<32 weeks, \<28 weeks, or \<24 weeks
Mean gestational age at delivery	at delivery	Mean value of gestational age at delivery (weeks)
Premature rupture of membranes	at delivery	Incidence
Chorioamnionitis	at delivery	Incidence
Composite adverse neonatal outcome	Incidence between birth and 28 days of age	Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia, retinopathy, blood-culture proven sepsis
Maternal death	Between birth and 6 weeks postpartum	Incidence
Birth weight at birth	at delivery	Mean value (grams)
Gestational age at spontaneous rupture of membranes	at delivery	Mean value (weeks) through study completion

Trial Locations

Locations (8)

George Washington University; 🇺🇸 Washington, District of Columbia, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Austin Maternal Fetal Medicine St David's Health Care; 🇺🇸 Austin, Texas, United States

The Egyptian IVF Center; 🇪🇬 Cairo, Egypt

Bologna University; 🇮🇹 Bologna, Italy

University of Brescia; 🇮🇹 Brescia, Italy

Università degli Studi di Napoli "Federico II"; 🇮🇹 Naples, Italy

University of Barcelona; 🇪🇸 Barcelona, Spain