Enrolling by invitation NCT06875401
Long-Term Patient-Reported Maternal Outcomes Following Abdominal Cerclage for the Prevention of Preterm Birth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Abdominal cerclage (open or laparoscopic).
- Who it may be relevant to
- Registry conditions: Cerclage, Cervical, Cervical Insufficiency. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Procedure Abdominal cerclage (open or laparoscopic)
Participants who have had either an open transabdominal cerclage or laparoscopic abdominal cerclage procedure performed.
Primary outcome measures
- General Health Perception scale - SF-36 [Time frame: At enrollment]
- Hospital anxiety and depressen scale (HADS) [Time frame: At enrollment]
Secondary outcome measures (6)
- Pelvic pain [Time frame: At enrollment]
- Foreign body sensation [Time frame: At enrollment]
- Trust in the cerclage [Time frame: At enrollment]
- Bladder discomfort [Time frame: At enrollment]
- Sexual health [Time frame: At enrollment]
- SF - 36 QOL [Time frame: At enrollment]
Eligibility criteria
Inclusion criteria
- Transabdominal cerclage
Exclusion criteria
- Most recent birth within 6 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus N
Publications
- Hansen LK, Glavind J, Shennan AH, Uldbjerg N, Lou S, Kesmodel US, Jensen PT. Quality-of-life and late effects after transabdominal cerclage: A nationwide matched cohort study. Acta Obstet Gynecol Scand. 2026 Aug 4:10.1111/aogs.70324. doi: 10.1111/aogs.70324. Online ahead of print. PMID 42549482
Identifiers
NCT: NCT06875401 · 1-45-70-80-24