NCT06875401

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 6, 2025

Last Update Submit

March 12, 2025

Conditions

Cerclage, CervicalCervical Insufficiency

Keywords

Patient reported outcomes (PRO)Quality of lifePreterm birthAbdominal cerclage

Outcome Measures

Primary Outcomes (2)

  • General Health Perception scale - SF-36

    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.

    At enrollment

  • Hospital anxiety and depressen scale (HADS)

    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.

    At enrollment

Secondary Outcomes (6)

  • Pelvic pain

    At enrollment

  • Foreign body sensation

    At enrollment

  • Trust in the cerclage

    At enrollment

  • Bladder discomfort

    At enrollment

  • Sexual health

    At enrollment

  • +1 more secondary outcomes

Study Arms (4)

Transabdominal cerclage

Participants with a transabdominal cerclage and subsequent birth

Procedure: Abdominal cerclage (open or laparoscopic)

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 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.

Women with a transabdominal cerclage and no subsequent birth

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

Procedure: Abdominal cerclage (open or laparoscopic)

Interventions

Abdominal cerclage (open or laparoscopic)PROCEDURE

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

Transabdominal cerclageWomen with a transabdominal cerclage and no subsequent birth

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale biological sex
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Participants with a TAC compared to controls with no TAC. 2. Participants exposed to short versus longer time spans since TAC insertion. 3. Participants with a TAC and no subsequent birth versus TAC and at least one subsequent birth.

You may qualify if:

  • Transabdominal cerclage

You may not qualify if:

  • Most recent birth within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Uterine Cervical IncompetencePremature Birth

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Uterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAbortion, HabitualAbortion, SpontaneousPregnancy ComplicationsGenital DiseasesObstetric Labor, PrematureObstetric Labor Complications

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 13, 2025

Study Start

March 5, 2025

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

DK(1)