Comparison of Cervical Cerclage by Vaginal and by Laparoscopic Transabdominal Routes in the Periconceptional Period
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Data comparison.
- Who it may be relevant to
- Registry conditions: Cerclage, Cervical. Basic parameters: 18 years — 44 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- 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, oper
Primary outcome measures
- Comparison of elective cervical cerclage vaginally and laparoscopic transabdominal elective cervical cerclage [Time frame: up to 100 weeks]
Secondary outcome measures (1)
- Comparison of maternal and fetal outcomes between the two groups [Time frame: up to 100 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06788873 · ROUND-21