Recruiting

Observational Study

Sponsor:

Albany Medical College

Code:

NCT05501938

Conditions

Preterm Birth

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Physical Exam Indicated Cerclage

Study Details

Brief summary:

RCT assessing preterm delivery rate in singleton pregnancies having a physical-exam indicated cerclage placed between 24 weeks and 25 weeks and 6 days. Patients randomized to either cerclage intervention or routine standard of care (no cerclage).

Conditions

Preterm Birth

Study ID

NCT05501938

Start date

Aug 11, 2022

Status verified date

Aug, 2022

Completion date

Aug 11, 2023

Anticipated

Primary completion date

Aug 11, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Pregnant women 18 years of age or older
2. Nulliparous patient, has not had a preterm to term delivery
3. Singleton pregnancy
4. English or Spanish speaking
5. Asymptomatic cervical dilation between 1- 2 cm, without visible membranes beyond the external cervical os and without any evidence of infection, active labor or active bleeding between 24 0/7 and 25 6/7 weeks gestation

Exclusion Criteria:

1. Twin or higher order multi-fetal gestation
2. Multiparous patient, has had one or more preterm to term deliveries
3. Cervical dilation more than 2 cm either at the beginning of the study or any time during the study
4. Amniotic membranes prolapsed beyond the external os
5. Fetal reduction procedure performed during current pregnancy
6. Ruptured membranes prior to randomization
7. Major fetal structural anomaly
8. Fetal chromosomal abnormality, suspected or confirmed with additional genetic testing
9. Cerclage already in place for other indication
10. Active vaginal bleeding
11. Suspicion of chorioamnionitis
12. Placenta previa
13. Painful regular uterine contractions
14. History of preterm birth before 37 weeks gestation
15. Non-English or non-Spanish speaking

a. Given that the study is explained in person and consent forms are written in English, there is no guarantee that the study will be explained correctly when using a phone translator. The same is true if the current English consent form were to be translated into a language other than English. There is no way to confirm that the integrity of the study is being upheld by using translating services. If the integrity of the study is not upheld, then this poses harm to the patient.
16. Women under 18 years of age

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cerclage

Perform physical exam indicated cerclage between 24w0d to 25w6d

no intervention: Control

No intervention; routine monitoring in pregnancy for preterm delivery

Interventions

Physical Exam Indicated Cerclage

Transvaginal cervical cerclage

Primary outcome measure

  • Preterm Delivery Rate [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Locations

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

More Information

Sponsor

Albany Medical College

Last update posted

Aug 16, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2022-08-16.