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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06788873

Enrollment

Registered

2025-01-23

Start date

2022-05-15

Completion date

2026-12-31

Last updated

2025-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerclage, Cervical

Keywords

Vaginal cervical cerclage, Transabdominal cervical cerclage

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.

Interventions

OTHERData 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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 44 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of elective cervical cerclage vaginally and laparoscopic transabdominal elective cervical cerclage	up to 100 weeks	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.

Secondary

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

Countries

Italy

Contacts

Primary ContactElisa Montaguti, MD

elisa.montaguti@aosp.bo.it0512144369

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026