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

Albany Medical College

Status: Enrolling

Conditions: Preterm Birth

Treatments: Procedure: Physical Exam Indicated Cerclage

Study type: Interventional

Funder types: Other

Identifiers

NCT05501938

6456

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Cerclage

Experimental group

Description:

Perform physical exam indicated cerclage between 24w0d to 25w6d

Treatment:

Procedure: Physical Exam Indicated Cerclage

Control

No Intervention group

Description:

No intervention; routine monitoring in pregnancy for preterm delivery