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.
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.
Study Type
OBSERVATIONAL
Enrollment
60
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.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy
RECRUITINGComparison of elective cervical cerclage vaginally and laparoscopic transabdominal elective cervical cerclage
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.
Time frame: up to 100 weeks
Comparison of maternal and fetal outcomes between the two groups
Live birth rate, gestational age at delivery, neonatal weight, and need for admission of the newborn to the Neonatal Intensive Care Unit (NICU).
Time frame: up to 100 weeks
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