- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04742647
Single Versus Double Suture Cervical Cerclage to Prevent Preterm Birth
Single Versus Double Suture Cervical Cerclage to Prevent Preterm Birth: Prospective Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11794
- Recruiting
- Stony Brook University
-
Contact:
- Deidre Lee
- Phone Number: 631-444-9324
- Email: deidre.lee@stonybrookmedicine.edu
-
Principal Investigator:
- Diana Garretto, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Rescue cerclage
- Carrying a fetus with known aneuploidy or anomaly
- Fetal demise
- Clinical intra-amniotic infection
- Rupture of membranes
- Multiple gestation
- Placental Abruption
- Technique other than McDonald
- Abdominal cerclage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Cerclage
Standard single cervical cerclage will be placed
|
One cerclage will be placed
|
Experimental: Double Cerclage
Double cerclage placement
|
Two cervical cerlages will be placed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preterm delivery <28 weeks gestation
Time Frame: through study completion, an average of 1 year
|
Birth occurring less than 28 weeks and 0 days
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preterm delivery <34 weeks gestation
Time Frame: through study completion, an average of 1 year
|
Birth occurring less than 34 weeks and 0 days
|
through study completion, an average of 1 year
|
Preterm delivery <37 weeks gestation
Time Frame: through study completion, an average of 1 year
|
Births occurring less than 37 weeks and 0 days
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2020-00731
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Single cerclage
-
Aarhus University HospitalOdense University Hospital; Oslo University Hospital; Rigshospitalet, Denmark; Hvidovre... and other collaboratorsNot yet recruitingPreterm Birth | Cervical Insufficiency
-
Centre of Postgraduate Medical EducationPomeranian Medical University Szczecin; Nicolaus Copernicus University; Medical... and other collaboratorsRecruiting
-
Obstetrix Medical GroupTerminatedFetal Membranes, Premature RuptureUnited States
-
Zagazig UniversityRecruitingPreterm Birth | Twin Pregnancy With Antenatal Problem | Cervical ShorteningEgypt
-
Zagazig UniversityRecruitingPreterm Birth | Twin Pregnancy, Antepartum Condition or Complication | Cervical CerclageEgypt
-
Quanta MedicalCousin BiotechRecruiting
-
University of AarhusCompletedCervical Insufficiency | Pre-Term
-
St. Louis UniversityTerminated
-
Rambam Health Care CampusUnknown