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Preterm birth is a leading cause of neonatal mortality and morbidity. Cervical insufficiency is one factor implicated in the complex mechanisms involved in spontaneous preterm birth. Trans-abdominal insertion of a cervical cerclage suture can be used to treat cervical insufficiency. Growing evidence support that laparoscopic cerclage procedures are safe and effective. Still, many aspects of the laparoscopic cerclage remains uncertain. Therefore, the investigators plan to study the obstetric outcome from the first and subsequent pregnancies after laparoscopic cerclage in a Danish cohort from Aarhus University Hospital in a 10 years' period.
Please see attached study protocol for further desricption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic cerclage | Patients who underwent laparoscopic cerclage at Aarhus University Hospital, Denmark in the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic cerclage placement | Procedure | The surgical method of the laparoscopic cerclage procedure at Aarhus University Hospital previous described in a paper by Riiskjaer et al (DOI: 10.1111/aogs.12001) |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal survival (defined as survival at time of discharge from hospital) | no. (reported for first, and consecutive deliveries) | From birth until discharge, an average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of neonates surviving with major neonatal morbidity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal characteristics |
| At delivery |
| Number of early complications from the laparoscopic cerclage procedure |
Inclusion Criteria:
Exclusion Criteria:
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Persons at risk of preterm birth who were offered and underwent laparoscopic cerclage surgery at Aarhus University Hospital, Denmark in the period from May 2011 till May 2021.
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| Name | Affiliation | Role |
|---|---|---|
| Lise Q Krogh, MD | Aarhus University Hospital/Aarhus University | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 31, 2023 | Jul 31, 2023 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2023 | Jul 31, 2023 | SAP_004.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D002581 | Uterine Cervical Incompetence |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| From birth until discharge, an average of 8 weeks |
| Number of pregnancies | no. | From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends) |
| Number of miscarriages |
| From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends) |
| Deliveries |
| From birth until discharge, an average of 8 weeks |
| Number of uterine ruptures | no. | From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends) |
| Time to first pregnancy (years and days) | no. | From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends) |
|
| 30 days from the procedure |
| Number of late complications from the laparoscopic cerclage procedure |
| From the laparoscopic cerclage until May 1, 2023 (two years after the enrollment period ends) |
| D000091642 | Urogenital Diseases |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D000026 | Abortion, Habitual |
| D000022 | Abortion, Spontaneous |
| D000091662 | Genital Diseases |