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

NCT06788873 | Recruiting

• 1 other identifier: ROUND-21
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerclage, Cervical

Keywords

Vaginal cervical cerclage; Transabdominal cervical cerclage

Outcome Measures

Primary Outcomes (1)

• Comparison of elective cervical cerclage vaginally and laparoscopic transabdominal elective cervical cerclage

  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.

  up to 100 weeks

Secondary Outcomes (1)

• Comparison of maternal and fetal outcomes between the two groups

  up to 100 weeks

Study Arms (2)

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

Other: Data comparison

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.

Other: Data comparison

Interventions

Data comparison 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; Single pregnancy and vaginal cerclage

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants with single pregnancy (within 12- 14 weeks of amenorrhea) and unfavorable obstetrical history (at least two preterm deliveries or abortions in the second trimester of pregnancy) who between 01/01/2002 and 31/12/2020 who underwent elective cervical cerclage vaginally and non-pregnant patients (with the same anamnestic characteristics as the first group) who underwent elective transabdominal laparoscopic cervical cerclage in the periconceptional period.

You may qualify if:

• 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

You may not qualify if:

• Multiple pregnancy

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Study Officials

• Elisa Montaguti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Montaguti, MD

CONTACT

0512144369; elisa.montaguti@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 23, 2025
• Study Start: May 15, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2025

Record last verified: 2024-10

Locations

IT (1)