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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03340688
Other study ID # 17D.326
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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