Physical Exam Indicated Cerclage in Singleton Gestation 24 Weeks to 25 Weeks and 6 Days Gestation

NCT ID: NCT05501938

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-11
• Study Completion Date: 2023-08-11

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cerclage

Perform physical exam indicated cerclage between 24w0d to 25w6d

Group Type: EXPERIMENTAL

Physical Exam Indicated Cerclage

Intervention Type: PROCEDURE

Transvaginal cervical cerclage

Control

No intervention; routine monitoring in pregnancy for preterm delivery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical Exam Indicated Cerclage

Transvaginal cervical cerclage

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Craig Zelig

Director of Maternal Fetal Medicine; MFM Fellowship Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Albany Medical Center

Albany, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Craig Zelig, MD

Role: CONTACT

zeligc@amc.edu

9105464305

Facility Contacts

Craig Zelig, MD

Role: primary

zeligc@amc.edu

910-546-4305

Other Identifiers

6456

Identifier Type: -

Identifier Source: org_study_id