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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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This study aims to explore the maternal patient reported outcomes on pelvic pain sexual health anxiety and depression bladder discomfort foreign body sensation trust in the cerclage, and how these parameters affect the general health perception in the quality of life of women treated with abdominal cerclages in Denmark since 2004.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transabdominal cerclage | Participants with a transabdominal cerclage and subsequent birth |
| |
| No abdominal cerclage, CS | Participants with no abdominal cerclage, but previous caesarean section. Participants matched on birth mode and -year, and age at time of cohort entry. | ||
| No abdominal cerclage, vaginal birth | Participants matched on birth year and age at time of cohort entry. Participants with a history of C-section and/or instrumental deliveries cannot enter this comparison group. | ||
| Women with a transabdominal cerclage and no subsequent birth | Participants who underwent the abdominal cerclage procedure, but did not become pregnant after the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal cerclage (open or laparoscopic) | Procedure | Participants who have had either an open transabdominal cerclage or laparoscopic abdominal cerclage procedure performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| General Health Perception scale - SF-36 | The difference in general health perception as measured by patient reported outcome measures (PROMS) in participants treated with TAC. A difference of 10 points or more is regarded as a clinically relevant difference. | At enrollment |
| Hospital anxiety and depressen scale (HADS) | The difference in depression and anxiety scores as measured by PROMS in participants who did not give birth since the TAC. The outcome is categorized in normal, borderline abnormal or abnormal. | At enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic pain | This issue was conceptualized as pelvic or vaginal pain (pressure, sharp, cramping or pulling) that may be intermittent and worsens with activity or at the end of the day. Questionnaire: The Danish Chronic Pelvic Pain Questionnaire | At enrollment |
| Foreign body sensation |
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Inclusion Criteria:
Exclusion Criteria:
Female biological sex
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus N | 8200 | Denmark |
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| ID | Term |
|---|---|
| D002581 | Uterine Cervical Incompetence |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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This issue was conceptualized as awareness and reminding of having the cerclage. Consists of two qualitatively pilot tested ad hoc questions. |
| At enrollment |
| Trust in the cerclage | This issue was conceptualized as trust in the effectiveness of the cerclage to prevent preterm birth. Consists of two qualitatively pilot tested ad hoc questions. | At enrollment |
| Bladder discomfort | This issue was conceptualized bladder discomfort as "Frequency, nocturia, urgency, urge incontinence (overactive bladder), Incontinence, bladder pain". The Bristol Female Lower Urinary Tract Symptoms questionnaire - short form (ICIQ-FLUTS-SF).
| At enrollment |
| Sexual health | This issue was conceptualized as sexual desire, arousal and dyspareunia. Questionnaire: Female Sexual Function Index Scoring (FSFI).
| At enrollment |
| SF - 36 QOL |
| At enrollment |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000026 | Abortion, Habitual |
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D000091662 | Genital Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |