Recruiting

Ultrasound Indicated Cerclage

Sponsor:

Thomas Jefferson University

Code:

NCT03340688

Conditions

Twin Pregnancy With Antenatal Problem

Preterm Birth

Short Cervix

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Cervical cerclage

Study Details

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.

Conditions

Twin Pregnancy With Antenatal Problem

Preterm Birth

Short Cervix

Study ID

NCT03340688

Start date

Jun 22, 2017

Status verified date

Apr, 2020

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cervical cerclage + vaginal progesterone

Cervical cerclage in twin pregnancy with transvaginal cervical length ≤15mm and Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks

no intervention: Vaginal progesterone

Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks

Interventions

Cervical cerclage

Cervical cerclage indicated by short cervix ≤15mm

Primary outcome measure

  • Preterm delivery less than 34 weeks [ Time Frame: at delivery ]

Central Contacts and Locations

Central contacts

Amanda Roman, MD

215.955.9200amanda.roman@jefferson.edu

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Amanda Roman, MD

215-955-9200amanda.roman@jefferson.edu

Austin Maternal Fetal Medicine St David's Health Care

Recruiting

Austin, Texas, United States, 78758

Contacts

sinahaeri@gmail.com

More Information

Sponsor

Thomas Jefferson University

Last update posted

Apr 27, 2020

Last verified

Apr, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2020-04-27.