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Single Versus Double Suture Cervical Cerclage to Prevent Preterm Birth

NCT04742647 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-10-27

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Double cerclage

Two cervical cerlages will be placed

PROCEDURE

Single cerclage

One cerclage will be placed

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-07-01
Completion
2023-07-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742647 on ClinicalTrials.gov