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The Primary Outcome is Preterm Delivery Before 28 Weeks Gestational Age Compared to Women With One vs Two Cerclages PlacedNCT04742647

Single Versus Double Suture Cervical Cerclage to Prevent Preterm Birth

A study testing Double cerclage and Single cerclage in people with The Primary Outcome is Preterm Delivery Before 28 Weeks Gestational Age Compared to Women With One vs Two Cerclages Placed, run by Stony Brook University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Cerclage placement is known to be beneficial in prevention of preterm birth when placed inn a certain subset of patients. Clinically, the number of sutures can also vary by surgeon preference to one or two sutures in one procedure. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Double cerclage and Single cerclage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteUnited States
Study dates
1 Feb 2021to 1 Jul 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

  • 18 years of age and older
  • Confirmed intrauterine, live pregnancy
  • Singleton gestation
  • Cerclage indications including:
  • Prophylactic due to history of cervical insufficiency, second trimester loss
  • Ultrasound indicated short cervix <25 mm prior to 24 weeks

Who cannot join

  • Rescue cerclage
  • Carrying a fetus with known aneuploidy or anomaly
  • Fetal demise
  • Clinical intra-amniotic infection
  • Rupture of membranes
  • Multiple gestation
Show all 9Show fewer
  • Placental Abruption
  • Technique other than McDonald
  • Abdominal cerclage

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • Stony Brook University

    Stony Brook, New York, 11794

    Deidre Lee, 631-444-9324, deidre.lee@stonybrookmedicine.edu

    Diana Garretto, MD

    Recruiting

Other trials in United States

About this study

Official title: Single Versus Double Suture Cervical Cerclage to Prevent Preterm Birth: Prospective Randomized Controlled Trial

Cerclage placement is known to be beneficial in prevention of preterm birth when placed inn a certain subset of patients. Clinically, the number of sutures can also vary by surgeon preference to one or two sutures in one procedure. This is often decided in the operating room (OR) on the day of surgery but is poorly studied in the efficacy of maintaining the closed cervical length. Retrospective data found no significant benefit on placing two stitches instead of one in preterm birth rate but was extremely limited and heterogenous in many clinical characteristic among the cerclage procedures. There were suggestions that two cerclage sutures may reduce the risk of cerclage revision, birth before 20 weeks, and a nonsignificant improvement in outcome of early preterm deliveries. Therefore, two randomized controlled trials, one prospective study and one meta-analysis were performed. They did suggest a beneficial effect of double cerclage on obstetrical outcomes especially in earlier preterm birth rates although all were limited in sample size and therefore power. A randomized control trial with adequate sample size is still needed to answer the question of whether double cervical cerclage suture is more beneficial than a single suture. Therefore, we propose conducting a randomized control trial between a single or double suture in prophylactic and ultrasound indicated cerclage procedures.

Read the detailed description

Preterm birth (PTB), defined as birth at less than 37 completed weeks is the leading cause for neonatal mortality and morbidity in the USA. The most common risk factor for PTB is a prior preterm birth. The etiology includes several risk factors including prior preterm birth, cervical insufficiency, short cervical length, low socioeconomic and educational status, extremes of maternal age, genital tract infection/colonization, smoking, underlying chronic disease, uterine anomalies, cervical surgery, injury to the endometrium, race, and exposure to environmental factors. The objective of our study specifically focuses on cervical insufficiency and a short cervical length at <24 weeks gestation defined as less than 25 mm as measured by transvaginal ultrasonography. It is well known that infants born prematurely have increased morbidity and mortality, including respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, long term health and neurologic abnormalities, extensive hospital stays, neonatal death, etc. The risks are significantly more pronounced at earlier gestational ages. Cervical cerclage, when indicated, has been shown to be beneficial in reducing preterm birth rates and therefore decrease adverse neonatal outcomes, perinatal morbidity, and mortality. The indications for cervical cerclage include a history of recurrent second trimester losses and/or PTB (history indicated), short cervical length (<2.5cm on transvaginal ultrasound (ultrasound indicated), or a dilated cervix on physical exam (physical exam indicated). Our study focuses on history and ultrasound indicated cerclage.

There are various surgical approaches to placement of cervical cerclages- transvaginal and transabdominal. Our study focuses on the transvaginal approach and the modified McDonald technique with transvaginal placement of a purse-string suture at the cervicovaginal junction. Suture material varies by the surgeon's preference and can involve monofilament suture (Prolene), polyester fiber (Mersilene tape), or a braided polyester suture (Ti-Cron or Ethibond). Clinically, the number of sutures can also vary by surgeon preference to one or two sutures in one procedure. This is often decided in the operating room (OR) on the day of surgery but is poorly studied in the efficacy of maintaining the closed cervical length. Retrospective data found no significant benefit on placing two stitches instead of one in preterm birth rate but was extremely limited and heterogenous in many clinical characteristic among the cerclage procedures. There were suggestions that two cerclage sutures may reduce the risk of cerclage revision, birth before 20 weeks, and a nonsignificant improvement in outcome of early preterm deliveries. Therefore, two randomized controlled trials one prospective study and one meta-analysis were performed. They did suggest a beneficial effect of double cerclage on obstetrical outcomes especially in earlier preterm birth rates although all were limited in sample size and therefore power. A randomized control trial with adequate sample size is still needed to answer the question of whether double cervical cerclage suture is more beneficial than a single suture.

Being tested
Double cerclage, Single cerclage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double cerclageProcedure or surgery

    Two cervical cerlages will be placed

  • Single cerclageProcedure or surgery

    One cerclage will be placed

Study groups in NCT04742647
Study groupRoleWhat they receive
Single CerclageExperimentalStandard single cervical cerclage will be placed
Receives: Procedure: Single cerclage
Double CerclageExperimentalDouble cerclage placement
Receives: Procedure: Double cerclage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preterm delivery <28 weeks gestation

    Birth occurring less than 28 weeks and 0 days

    Measured: through study completion, an average of 1 year

Secondary outcomes (2)
  1. Preterm delivery <34 weeks gestation

    Birth occurring less than 34 weeks and 0 days

    Measured: through study completion, an average of 1 year

  2. Preterm delivery <37 weeks gestation

    Births occurring less than 37 weeks and 0 days

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2021
  2. Study start1 Feb 2021
  3. Primary completion1 Jul 2023 (estimated)
  4. Study completion1 Jul 2023 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04742647
Sponsor's protocol ID
IRB2020-00731
Status last verified
Oct 2022
First submitted
29 Jan 2021
Last updated
27 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Double cerclage and Single cerclage in people with The Primary Outcome is Preterm Delivery Before 28 Weeks Gestational Age Compared to Women With One vs Two Cerclages Placed, run by Stony Brook University 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 6 inclusion and 9 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 27 Oct 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preterm delivery <28 weeks gestation (time frame: through study completion, an average of 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 27 Oct 2022.

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