Clinical trial NCT06788873: Comparison of Cervical Cerclage by Vaginal and by Laparoscopic Transabdominal Routes in the Periconceptional Period
Official title: Comparison of Elective Cervical Cerclage by Vaginal and by Laparoscopic Transabdominal Routes in the Periconceptional Period in the Patient with Unfavorable Obstetrical History
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerclage, Cervical
Keywords: Vaginal cervical cerclage
Transabdominal cervical cerclage
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Comparison of elective cervical cerclage vaginally and laparoscopic transabdominal elective cervical cerclage
timeFrame: up to 100 weeks
Secondary outcomes:
measure: Comparison of maternal and fetal outcomes between the two groups
timeFrame: up to 100 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Elisa Montaguti, MD
role: PRINCIPAL_INVESTIGATOR
References: