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Clinical Trials in Denmark / NCT06875401
Enrolling by invitation Observational

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

NCT06875401 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Aarhus
Phase
Observational
Started
2025-03-05
Last updated
2025-03-13

Condition(s) studied

Cerclage, CervicalCervical Insufficiency

Investigational drug(s) / intervention(s)

Abdominal cerclage (open or laparoscopic)

Abdominal cerclage (open or laparoscopic): Participants who have had either an open transabdominal cerclage or laparoscopic abdominal cerclage procedure performed.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Transabdominal cerclage Exclusion Criteria: * Most recent birth within 6 months

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus N Denmark

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Other trials for the same condition

Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06875401 on ClinicalTrials.gov ↗ ← All trials in Denmark