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

NCT ID: NCT06875401

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-05

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cerclage, Cervical Cervical Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transabdominal cerclage

Participants with a transabdominal cerclage and subsequent birth

Abdominal cerclage (open or laparoscopic)

Intervention Type PROCEDURE

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

No abdominal cerclage, CS

Participants with no abdominal cerclage, but previous caesarean section. Participants matched on birth mode and -year, and age at time of cohort entry.

No interventions assigned to this group

No abdominal cerclage, vaginal birth

Participants matched on birth year and age at time of cohort entry. Participants with a history of C-section and/or instrumental deliveries cannot enter this comparison group.

No interventions assigned to this group

Women with a transabdominal cerclage and no subsequent birth

Participants who underwent the abdominal cerclage procedure, but did not become pregnant after the procedure.

Abdominal cerclage (open or laparoscopic)

Intervention Type PROCEDURE

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

Interventions

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Abdominal cerclage (open or laparoscopic)

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Transabdominal cerclage

Exclusion Criteria

* Most recent birth within 6 months
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University Hospital

Aarhus N, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1-45-70-80-24

Identifier Type: -

Identifier Source: org_study_id

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