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

Recruiting

• Conditions: Cerclage, Cervical

• Registration Number: NCT06788873
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-05-15
• Status Verified: 2024-10
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of elective cervical cerclage vaginally and laparoscopic transabdominal elective cervical cerclage	up to 100 weeks	The patients for whom such treatment is reserved are those with unfavorable obstetrical history (at least 2 preterm deliveries or abortions in the second trimester of pregnancy), who have an extremely high risk of recurrence.

Secondary Outcome Measures

Name	Time	Method
Comparison of maternal and fetal outcomes between the two groups	up to 100 weeks	Live birth rate, gestational age at delivery, neonatal weight, and need for admission of the newborn to the Neonatal Intensive Care Unit (NICU).

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy