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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth
• Intervention / Treatment: Procedure: Physical Exam Indicated Cerclage

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Craig Zelig, MD; Phone Number: 9105464305; Email: zeligc@amc.edu

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical Center
      • Contact: Craig Zelig, MD; Phone Number: 910-546-4305; Email: zeligc@amc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cerclage; Perform physical exam indicated cerclage between 24w0d to 25w6d	Procedure: Physical Exam Indicated Cerclage; Transvaginal cervical cerclage
NO_INTERVENTION: Control; No intervention; routine monitoring in pregnancy for preterm delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerclage Surgical Complications	Rate of cerclage complications (intra-operative PPROM, hemorrhage, need for blood transfusion, cervical or vaginal laceration	1 year

Collaborators and Investigators

• Sponsor: Albany Medical College

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 11, 2022
• Primary Completion (ANTICIPATED): August 11, 2023
• Study Completion (ANTICIPATED): August 11, 2023

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (ACTUAL): August 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 6456

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No