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

March 12, 2025 updated by: University of Aarhus
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • Transabdominal cerclage

Exclusion Criteria:

  • Most recent birth within 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transabdominal cerclage
Participants with a transabdominal cerclage and subsequent birth
Procedure: Abdominal cerclage (open or laparoscopic)
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 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)
Participants who have had either an open transabdominal cerclage or laparoscopic abdominal cerclage procedure performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At enrollment
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.
At enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At enrollment
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.
At enrollment
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.
At enrollment
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)
At enrollment
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)
At enrollment
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)
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-45-70-80-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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