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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single pregnancy and vaginal cerclage | Participants with a single pregnancy and unfavorable obstetrical history (at least two preterm deliveries or abortions in the 2nd trimester of pregnancy) who underwent elective cervical cerclage vaginally between 01/01/2002 and 31/12/2020 |
| |
| No pregnancy and laparoscopic transabdominal cervical cerclage | Non-pregnant participants (with the same anamnestic characteristics as the first group) who underwent elective transabdominal laparoscopic cervical cerclage in the periconceptional period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data comparison | Other | For each participant, information will be collected on:
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison 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. | up to 100 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 100 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa Montaguti, MD | Contact | 0512144369 | elisa.montaguti@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Elisa Montaguti, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | Bologna | 40138 | Italy |
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