Cerclage, Cervical, Cervical Insufficiency
Conditions
Keywords
Patient reported outcomes (PRO), Quality of life, Preterm birth, Abdominal cerclage
Brief summary
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.
Interventions
PROCEDUREAbdominal cerclage (open or laparoscopic)
Participants who have had either an open transabdominal cerclage or laparoscopic abdominal cerclage procedure performed.
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Transabdominal cerclage
Exclusion criteria
* Most recent birth within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General Health Perception scale - SF-36 | At enrollment | 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. |
| Hospital anxiety and depressen scale (HADS) | At enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trust in the cerclage | At enrollment | 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. |
| Bladder discomfort | At enrollment | 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). * Filling (4 items, maximum score 16) * Voiding (3 items, maximum score 12) * Incontinence (4 items, maximum score 16) |
| Pelvic pain | At enrollment | 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 |
| SF - 36 QOL | At enrollment | * Physical functioning (10 items, maximum score 100) * Role limitations due to physical health problems (4 items, maximum score 100) * Role limitations due to emotional problems (3 items, maximum score 100) * Energy/fatigue (4 items, maximum score 100) * Emotional well-being (5 items, maximum score 100) * Social functioning (2 items, maximum score 100) * Bodily pain (2 items, maximum score 100) * General health perceptions (5 items, maximum score 100) |
| Sexual health | At enrollment | This issue was conceptualized as sexual desire, arousal and dyspareunia. Questionnaire: Female Sexual Function Index Scoring (FSFI). * Desire (2 items, maximum score 6) * Arousal (4 items, maximum score 6) * Lubrication (4 items, maximum score 6) * Orgasm (3 items, maximum score 6) * Satisfaction (3 items, maximum score 6) * Pain (3 items, maximum score 6) |
| Foreign body sensation | At enrollment | This issue was conceptualized as awareness and reminding of having the cerclage. Consists of two qualitatively pilot tested ad hoc questions. |
Countries
Denmark
Outcome results
None listed