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

Preterm Birth Clinical Trial

Official title:

Randomized Controlled Trial: Physical Exam Indicated Cerclage in Singleton Gestation 24 Weeks to 25 Weeks and 6 Days Gestation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05501938
• Other study ID #: 6456
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: August 11, 2023

Study information

• Verified date: August 2022
• Source: Albany Medical College
• Contact: Craig Zelig, MD
• Phone: 9105464305
• Email: zeligc[@]amc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 11, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Procedure:
• Physical Exam Indicated Cerclage
Transvaginal cervical cerclage

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerclage Surgical Complications	Rate of cerclage complications (intra-operative PPROM, hemorrhage, need for blood transfusion, cervical or vaginal laceration	1 year
Primary	Preterm Delivery Rate	Compare preterm delivery rate between women receiving cerclage intervention between 24w0d and 25w6d vs those not receiving cerclage during this gestational age period	1 Year
Secondary	Neonatal Outcomes	Rate of neonatal outcomes compared between the two groups ( NICU length of stay, neonatal death, neonatal disease (bronchopulmonary dysplasia, Necrotizing enterocolitis, Intraventricular hemorrhage, Respiratory distress syndrome, Retinopathy of prematurity, sepsis, death)	1 Year