Aarhus University Hospital
Aarhus N, 8200, Denmark
NCT Number: NCT06875401
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Aarhus N, 8200, Denmark
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants who have had either an open transabdominal cerclage or laparoscopic abdominal cerclage procedure performed.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: At enrollment
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
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
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).
Time frame: At enrollment
This issue was conceptualized as sexual desire, arousal and dyspareunia. Questionnaire: Female Sexual Function Index Scoring (FSFI).
Time frame: At enrollment
University of Aarhus
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04722536
Abortion, Habitual, Abortion, Spontaneous
Bron, France
View Trial DetailsNCT06788873
Cerclage, Cervical
Bologna, Italy
View Trial DetailsNCT03805438
Cerclage, Cervical
Little Rock, Arkansas, United States
View Trial DetailsNCT06915428
Abortion, Habitual, Abortion, Spontaneous
Chapel Hill, North Carolina, United States
View Trial Details