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.
Study Type
OBSERVATIONAL
Enrollment
1,200
Participants who have had either an open transabdominal cerclage or laparoscopic abdominal cerclage procedure performed.
Aarhus University Hospital
Aarhus N, Denmark
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.
Time frame: 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.
Time frame: At enrollment
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
Time frame: At enrollment
Foreign body sensation
This issue was conceptualized as awareness and reminding of having the cerclage. Consists of two qualitatively pilot tested ad hoc questions.
Time frame: 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.
Time frame: 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). * Filling (4 items, maximum score 16) * Voiding (3 items, maximum score 12) * Incontinence (4 items, maximum score 16)
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Time frame: At enrollment
Sexual health
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)
Time frame: At enrollment
SF - 36 QOL
* 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)
Time frame: At enrollment