Comparing two methods of cervical cerclage to prevent preterm delivery
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
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06788873 · Data updated 2026-11-12
This study is testing which of two surgical methods for cervical cerclage works better to help prevent preterm delivery in women who have had previous preterm births or miscarriages.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 44 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Status | Recruiting |
| Started | May 15, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 23, 2025 |
| Trial ID | NCT06788873 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with a history of at least two preterm deliveries or second-trimester abortions who have undergone elective cervical cerclage.
✕Probably not a fit
Patients with multiple pregnancies will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to compare the effectiveness of two surgical techniques for elective cervical cerclage: the vaginal route and the laparoscopic transabdominal route. Data will be collected from patients who have undergone these procedures as part of their normal care pathway, without additional study-specific visits. Participants will provide informed consent during a follow-up visit, and their clinical-demographic data will be pseudo-anonymized for analysis. The study focuses on patients with a history of preterm deliveries or second-trimester abortions.
Why it matters
Potential benefit: If successful, this study could help determine the more effective surgical technique for preventing preterm delivery in at-risk patients.
How similar studies have gone: While similar approaches have been used in clinical practice, this specific comparison of techniques is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy Recruiting
Study contacts
- Principal investigator: Elisa Montaguti, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Elisa Montaguti, MD
- Email: elisa.montaguti@aosp.bo.it
- Phone: 0512144369
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.