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

NCT ID: NCT06788873

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2026-12-31

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.

Conditions

Cerclage, Cervical

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Single pregnancy and vaginal cerclage

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

Data comparison

Intervention Type: OTHER

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.

No pregnancy and laparoscopic transabdominal cervical cerclage

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

Data comparison

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisa Montaguti, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Elisa Montaguti, MD

Role: CONTACT

elisa.montaguti@aosp.bo.it

0512144369

Facility Contacts

Elisa Montaguti, MD

Role: primary

elisa.montaguti@aosp.bo.it

0512144369

Other Identifiers

ROUND-21

Identifier Type: -

Identifier Source: org_study_id