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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Cerclage, Cervical

Treatments: Other: Data comparison

Study type: Observational

Funder types: Other

Identifiers

NCT06788873

ROUND-21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Single pregnancy and vaginal cerclage

Description:

Participants with a single pregnancy and unfavorable obstetrical history (at least two preterm deliveries or abortions in the 2nd trimester of pregnancy) who underwent elective cervical cerclage vaginally between 01/01/2002 and 31/12/2020

Treatment:

Other: Data comparison

No pregnancy and laparoscopic transabdominal cervical cerclage

Description:

Non-pregnant participants (with the same anamnestic characteristics as the first group) who underwent elective transabdominal laparoscopic cervical cerclage in the periconceptional period.

Treatment:

Other: Data comparison