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

NCT05501938 | Unknown DMC

• 1 other identifier: 6456
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neonatal Outcomes

  1 Year

Other Outcomes (1)

• Cerclage Surgical Complications

  1 year

Study Arms (2)

Cerclage

EXPERIMENTAL

Perform physical exam indicated cerclage between 24w0d to 25w6d

Procedure: Physical Exam Indicated Cerclage

Control

NO INTERVENTION

No intervention; routine monitoring in pregnancy for preterm delivery

Interventions

Physical Exam Indicated Cerclage PROCEDURE

Transvaginal cervical cerclage

Cerclage

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women 18 years of age or older
• Nulliparous patient, has not had a preterm to term delivery
• Singleton pregnancy
• English or Spanish speaking
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Craig Zelig, MD

CONTACT

9105464305; zeligc@amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Maternal Fetal Medicine; MFM Fellowship Director

Model Details: Intervention (cerclage) and control (no-cerclage) to reduce/prevent preterm delivery in those with a dilated cervix between 24w0d and 25w6d

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 16, 2022
• Study Start: August 11, 2022
• Primary Completion: August 11, 2023
• Study Completion: August 11, 2023
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

US (1)