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Comparison of Cervical Cerclage by Vaginal and by Laparoscopic Transabdominal Routes in the Periconceptional Period

Comparison of Cervical Cerclage by Vaginal and by Laparoscopic Transabdominal Routes in the Periconceptional Period

Recruiting
18-44 years
Female
Phase N/A

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Overview

The goal of this observational study is to compare two different surgical techniques of performing elective cervical cerclage in the prevention of preterm delivery, both of which are already widely used in common clinical practice: elective cervical cerclage by the vaginal route and laparoscopic transabdominal elective cervical cerclage.

Description

For the purpose of this study, no study-specific visits are planned. Data will be collected in a pseudo-anonymized manner, assigning each participant a sequence number.

For patients who undergo elective vaginal cervical cerclage at the division of Obstetrics and Prenatal Age Medicine or laparoscopic cerclage at the division of Gynecology and Human Reproductive Pathophysiology, the normal care pathway does not include additional follow-up visits for outpatient follow-up visits.

Regarding data collected in the past as part of the normal care pathway, patients will be asked to give informed consent in the context of a follow-up visit at which a practice staff member will be present.

Eligibility

Inclusion Criteria:

  • Patients with unfavorable obstetric history, i.e., at least two previous preterm deliveries or second-trimester abortions who underwent elective prophylactic cervical cerclage (vaginal or laparoscopic) between 01/01/2002 and 31/12/2020
  • Age ≥18 years
  • Obtaining informed consent form
  • Availability of clinical-demographic data

Exclusion Criteria:

  • Multiple pregnancy

Study details
    Cerclage
    Cervical

NCT06788873

IRCCS Azienda Ospedaliero-Universitaria di Bologna

16 October 2025

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