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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerclage, Cervical
• Intervention / Treatment: Other: Data comparison

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Elisa Montaguti, MD; Phone Number: 0512144369; Email: elisa.montaguti@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Elisa Montaguti, MD; Phone Number: 0512144369; Email: elisa.montaguti@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Elisa Montaguti, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Vaginal cervical cerclage; Transabdominal cervical cerclage
• Other Study ID Numbers: ROUND-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No