Actively Recruiting
Comparison of Elective Cervical Cerclage by Vaginal and Laparoscopic Transabdominal Routes in the Periconceptional Period for Patients with Unfavorable Obstetrical History
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-23
60
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two surgical methods for elective cervical cerclage to prevent preterm delivery in women with a history of unfavorable obstetric outcomes. The study compares the vaginal route and the laparoscopic transabdominal route, both commonly used in clinical practice for this purpose. The goal is to understand differences in outcomes between these two approaches. Participants undergo either elective vaginal cervical cerclage or laparoscopic cerclage as part of their normal care. No additional study-specific visits are required. Data collection includes details such as gestational age at cerclage, parity, age, BMI, ethnicity, history of preterm deliveries, previous uterine or cervical surgeries, operative times, hospital stay duration, surgical complications, delivery details, infant birth weight, Apgar scores, newborn pH, and neonatal intensive care admissions. Participants provide informed consent during routine follow-up visits, and data are collected in a pseudo-anonymized manner. Researchers will compare outcomes over a period of up to 100 weeks, focusing on the effectiveness and safety of the two surgical techniques. The study involves women aged 18 to 44 years with a history of at least two preterm deliveries or second-trimester abortions who underwent elective prophylactic cervical cerclage.
CONDITIONS
Official Title
Comparison of Cervical Cerclage by Vaginal and by Laparoscopic Transabdominal Routes in the Periconceptional Period
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with unfavorable obstetric history, with 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 or older
- Informed consent obtained
- Availability of clinical and demographic data
You will not qualify if you...
- Multiple pregnancy
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Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
E
Elisa Montaguti, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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