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Enrolling by Invitation

NCT Number: NCT06875401

Long-Term Patient-Reported Maternal Outcomes Following Abdominal Cerclage for the Prevention of Preterm Birth

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.

Enrolling by Invitation

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Transabdominal cerclage

Exclusion criteria

  • Most recent birth within 6 months

Treatment and study plan

Abdominal cerclage (open or laparoscopic)

Procedure

Participants who have had either an open transabdominal cerclage or laparoscopic abdominal cerclage procedure performed.

Primary outcomes

  1. General Health Perception scale - SF-36

    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.

  2. Hospital anxiety and depressen scale (HADS)

    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.

Secondary outcomes

  1. Pelvic pain

    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

  2. Foreign body sensation

    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.

  3. Trust in the cerclage

    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.

  4. Bladder discomfort

    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).

    • Filling (4 items, maximum score 16)
    • Voiding (3 items, maximum score 12)
    • Incontinence (4 items, maximum score 16)
  5. Sexual health

    Time frame: 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)
  6. SF - 36 QOL

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

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.

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