Single Versus Double Suture Cervical Cerclage to Prevent Preterm Birth

• ClinicalTrials.gov Identifier: NCT04742647
• Recruitment Status: Recruiting
• First Posted: February 8, 2021
• Last Update Posted: March 17, 2021
• Sponsor: Stony Brook University
• Information provided by (Responsible Party): Diana Garretto, Stony Brook University

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
The Primary Outcome is Preterm Delivery Before 28 Weeks Gestational Age Compared to Women With One vs Two Cerclages Placed	Procedure: Double cerclage; Procedure: Single cerclage	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Single Versus Double Suture Cervical Cerclage to Prevent Preterm Birth: Prospective Randomized Controlled Trial
• Actual Study Start Date: February 1, 2021
• Estimated Primary Completion Date: July 1, 2023
• Estimated Study Completion Date: July 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Single Cerclage; Standard single cervical cerclage will be placed	Procedure: Single cerclage; One cerclage will be placed
Experimental: Double Cerclage; Double cerclage placement	Procedure: Double cerclage; Two cervical cerlages will be placed

Outcome Measures

Primary Outcome Measures :

1. Preterm delivery <28 weeks gestation [ Time Frame: through study completion, an average of 1 year ]
   Birth occurring less than 28 weeks and 0 days

Secondary Outcome Measures :

1. Preterm delivery <34 weeks gestation [ Time Frame: through study completion, an average of 1 year ]
   Birth occurring less than 34 weeks and 0 days
2. Preterm delivery <37 weeks gestation [ Time Frame: through study completion, an average of 1 year ]
   Births occurring less than 37 weeks and 0 days

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, New York

Stony Brook University; Recruiting

Stony Brook, New York, United States, 11794

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

Principal Investigator: Diana Garretto, MD

Sponsors and Collaborators

Stony Brook University

More Information

• Responsible Party: Diana Garretto, MD Clinical Assistant Professor, Obstetric Quality Assurance Chair, Director Obstetric Ultrasound, Stony Brook University
• ClinicalTrials.gov Identifier: NCT04742647
• Other Study ID Numbers: IRB2020-00731
• First Posted: February 8, 2021
• Last Update Posted: March 17, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications