Cerclage for Twins With Short Cervical Length ≤ 15mm

Preterm Birth Clinical Trial

— TWIN-UIC  

Official title:

Cervical Cerclage for Preventing Spontaneous Preterm Birth in Twin Pregnancies With Transvaginal Ultrasound Cervical Length ≤ 15mm: a Study Protocol for a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03340688
• Other study ID #: 17D.326
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2017
• Est. completion date: June 2025

Study information

• Verified date: April 2020
• Source: Thomas Jefferson University
• Contact: Amanda Roman, MD
• Phone: 215.955.9200
• Email: amanda.roman[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth
• Short Cervix
• Twin Pregnancy With Antenatal Problem

Intervention

Procedure:
• Cervical cerclage
Cervical cerclage indicated by short cervix =15mm

Locations

Country	Name	City	State
Egypt	The Egyptian IVF Center	Cairo
Italy	Bologna University	Bologna
Italy	University of Brescia	Brescia
Italy	Università degli Studi di Napoli "Federico II"	Naples
Spain	University of Barcelona	Barcelona
United States	Austin Maternal Fetal Medicine St David's Health Care	Austin	Texas
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	George Washington University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Federico II University

Countries where clinical trial is conducted

United States,  Egypt,  Italy,  Spain, 

References & Publications (6)

Conde-Agudelo A, Romero R, Hassan SS, Yeo L. Transvaginal sonographic cervical length for the prediction of spontaneous preterm birth in twin pregnancies: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Aug;203(2):128.e1-12. doi: 10.1016/j — View Citation

Goldenberg RL, Iams JD, Miodovnik M, Van Dorsten JP, Thurnau G, Bottoms S, Mercer BM, Meis PJ, Moawad AH, Das A, Caritis SN, McNellis D. The preterm prediction study: risk factors in twin gestations. National Institute of Child Health and Human Developmen — View Citation

Hamilton BE, Hoyert DL, Martin JA, Strobino DM, Guyer B. Annual summary of vital statistics: 2010-2011. Pediatrics. 2013 Mar;131(3):548-58. doi: 10.1542/peds.2012-3769. Epub 2013 Feb 11. — View Citation

Roman A, Rochelson B, Fox NS, Hoffman M, Berghella V, Patel V, Calluzzo I, Saccone G, Fleischer A. Efficacy of ultrasound-indicated cerclage in twin pregnancies. Am J Obstet Gynecol. 2015 Jun;212(6):788.e1-6. doi: 10.1016/j.ajog.2015.01.031. Epub 2015 Jan — View Citation

Romero R, Conde-Agudelo A, El-Refaie W, Rode L, Brizot ML, Cetingoz E, Serra V, Da Fonseca E, Abdelhafez MS, Tabor A, Perales A, Hassan SS, Nicolaides KH. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a tw — View Citation

Saccone G, Rust O, Althuisius S, Roman A, Berghella V. Cerclage for short cervix in twin pregnancies: systematic review and meta-analysis of randomized trials using individual patient-level data. Acta Obstet Gynecol Scand. 2015 Apr;94(4):352-8. doi: 10.11 — View Citation

Outcome

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