Preterm BirthNCT05501938
Physical Exam Indicated Cerclage in Singleton Gestation 24 Weeks to 25 Weeks and 6 Days Gestation
A study testing Physical Exam Indicated Cerclage in people with Preterm Birth, run by Albany Medical College at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Physical Exam Indicated Cerclage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2022to 11 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Albany Medical Center
Albany, New York, 12208
Craig Zelig, MD, 910-546-4305, zeligc@amc.edu
About this study
Official title: 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).
- Conditions
- Preterm Birth
- Being tested
- Physical Exam Indicated Cerclage
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Exam Indicated CerclageProcedure or surgery
Transvaginal cervical cerclage
| Study group | Role | What they receive |
|---|---|---|
| Cerclage | Experimental | Perform physical exam indicated cerclage between 24w0d to 25w6d Receives: Procedure: Physical Exam Indicated Cerclage |
| Control | No intervention | No intervention; routine monitoring in pregnancy for preterm delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 Year
Secondary outcomes (1)
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)
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start11 Aug 2022 (estimated)
- Primary completion11 Aug 2023 (estimated)
- Study completion11 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Zelig, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501938
- Sponsor's protocol ID
- 6456
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Physical Exam Indicated Cerclage in Singleton Gestation 24 Weeks to 25 Weeks and 6 Days Gestation
- ClinicalTrials.gov ID
- NCT05501938
- Acronym / sponsor ID
- 6456
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 11 Aug 2022 (estimated)
- Primary completion
- 11 Aug 2023 (estimated)
- Study completion
- 11 Aug 2023 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention (cerclage) and control (no-cerclage) to reduce/prevent preterm delivery in those with a dilated cervix between 24w0d and 25w6d
| Arm | Type | Receives |
|---|---|---|
| Cerclage | Experimental | Procedure: Physical Exam Indicated CerclagePerform physical exam indicated cerclage between 24w0d to 25w6d |
| Control | No intervention | –No intervention; routine monitoring in pregnancy for preterm delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Exam Indicated CerclageTransvaginal cervical cerclage | Procedure or surgery | Cerclage |
Primary outcome
Preterm Delivery Rate
Time frame: 1 Year
Compare preterm delivery rate between women receiving cerclage intervention between 24w0d and 25w6d vs those not receiving cerclage during this gestational age period
1 secondary outcome
Neonatal Outcomes
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exam Indicated Cerclage in people with Preterm Birth, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Craig Zelig, MD (9105464305, zeligc@amc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm Delivery Rate (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.