Physical Exam Indicated Cerclage in Twin Gestations



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 60
Updated:10/12/2018
Start Date:June 2015
End Date:July 2020
Contact:Amanda Roman, MD
Email:amanda.roman@jefferson.edu
Phone:215.955.9200

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Randomized Control Trial Physical Exam Indicated Cerclage in Twin Gestations

This is a multicenter randomized study designed to determine if physical exam indicated
cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women
with twin gestations and dilated cervix, diagnosed by pelvic exam between 16 to 23 6/7 weeks
of gestation.

Twin pregnancies have 50% 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. When cervical dilation is identified before 24 weeks in
singleton pregnancies, the risk of preterm birth is 90%-100%; based on a small series of
cases, approximately 50% of twin gestations with cervical dilation will be delivered prior to
viability (24 weeks) and the risk of preterm birth prior to 34 and 37 weeks was 85% and 100%.
Cervical dilation is the worst prognostic factor for preterm birth. There are a small number
of case reports of cervical cerclage in twin pregnancies with dilated cervix that suggest
similar outcomes to those in singleton pregnancies. The investigators' objective is to
determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm
birth <34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and
dilated cervix (1 to 5 cm) between 16 to 23 6/7 weeks of gestation.

Inclusion Criteria:

1. Pregnant women older than 18 years of age

2. Diamniotic twin pregnancy

3. Cervical dilation between 1 to 5 cm and/or visible membranes by pelvic exam or
speculum exam between at 16-23 6/7 weeks gestation

Exclusion Criteria:

1. Singleton pregnancy or higher order than twins multiple gestation

2. Cervical dilation more than 5 cm

3. Amniotic membranes prolapsed beyond external os into the vagina, unable to visualize
cervical tissue

4. More than 24 weeks of gestation

5. Multifetal reduction after 14 weeks

6. Monoamniotic twins

7. Twin-twin transfusion syndrome

8. Ruptured amniotic membranes at the time of diagnosis of dilated cervix

9. Major fetal structural anomaly

10. Fetal chromosomal abnormality

11. Cerclage already in place for other indications

12. Active vaginal bleeding

13. Suspicion of clinical or biochemical chorioamnionitis

14. Painful regular uterine contractions

15. Labor (progressing cervical dilation)

16. Placenta previa
We found this trial at
8
sites
630 W 168th St
New York, New York
212-305-2862
Phone: 347-514-0034
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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Albany, New York 12208
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Albany, NY
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Austin, TX
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Dayton, Ohio 45408
Phone: 937-208-4005
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Dayton, OH
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Naples,
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-9200
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Philadelphia, PA
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Washington, District of Columbia 20052
Phone: 202-741-2500
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Washington,
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