NCT06788873

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

Comparison of Elective Cervical Cerclage by Vaginal and by Laparoscopic Transabdominal Routes in the Periconceptional Period in the Patient with Unfavorable Obstetrical History

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerclage, Cervical

Interventions

Type	Name	Description
OTHER	Data comparison	For each participant, information will be collected on: * Gestational age at the time the cerclage was performed * Parity * Age * BMI * Ethnicity * Number of preterm deliveries * Gestational age of previous preterm deliveries * Previous uterine and/or cervix surgery (previous cerclage, conization, metroplasty, or other) * Type of cerclage performed * Operative times * Days of hospitalization * Surgical complications * Gestational age at the time of delivery * Mode of delivery (spontaneous, operative or cesarean) * Infant's weight at birth * Apgar at 1' and 5' minute * Ph newborn * Possible admission to neonatal intensive care unit.

Timeline

• Start date: 2022-05-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-01-23
• Last updated: 2025-01-23

Locations

1 site across 1 country: Italy