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

Primary Purpose

Preterm Birth

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Exam Indicated Cerclage
Sponsored by
Albany Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Albany Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cerclage

Control

Arm Description

Perform physical exam indicated cerclage between 24w0d to 25w6d

No intervention; routine monitoring in pregnancy for preterm delivery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
August 11, 2022
Last Updated
August 12, 2022
Sponsor
Albany Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05501938
Brief Title
Physical Exam Indicated Cerclage in Singleton Gestation 24 Weeks to 25 Weeks and 6 Days Gestation
Official Title
Randomized Controlled Trial: Physical Exam Indicated Cerclage in Singleton Gestation 24 Weeks to 25 Weeks and 6 Days Gestation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2022 (Anticipated)
Primary Completion Date
August 11, 2023 (Anticipated)
Study Completion Date
August 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention (cerclage) and control (no-cerclage) to reduce/prevent preterm delivery in those with a dilated cervix between 24w0d and 25w6d
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cerclage
Arm Type
Experimental
Arm Description
Perform physical exam indicated cerclage between 24w0d to 25w6d
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention; routine monitoring in pregnancy for preterm delivery
Intervention Type
Procedure
Intervention Name(s)
Physical Exam Indicated Cerclage
Intervention Description
Transvaginal cervical cerclage
Primary Outcome Measure Information:
Title
Preterm Delivery Rate
Description
Compare preterm delivery rate between women receiving cerclage intervention between 24w0d and 25w6d vs those not receiving cerclage during this gestational age period
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Neonatal Outcomes
Description
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)
Time Frame
1 Year
Other Pre-specified Outcome Measures:
Title
Cerclage Surgical Complications
Description
Rate of cerclage complications (intra-operative PPROM, hemorrhage, need for blood transfusion, cervical or vaginal laceration
Time Frame
1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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. Women under 18 years of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Craig Zelig, MD
Phone
9105464305
Email
zeligc@amc.edu
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Zelig, MD
Phone
910-546-4305
Email
zeligc@amc.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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