Cerclage, CervicalNCT06875401
Long-Term Patient-Reported Maternal Outcomes Following Abdominal Cerclage for the Prevention of Preterm Birth
An observational study of Cerclage, Cervical and Cervical Insufficiency, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cerclage, Cervical, Cervical Insufficiency
- What is being tested?
- Abdominal cerclage (open or laparoscopic)
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Mar 2025to Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Transabdominal cerclage
Who cannot join
- Most recent birth within 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Cerclage, Cervical, Cervical Insufficiency
- Being tested
- Abdominal cerclage (open or laparoscopic)
- Keywords
- Patient reported outcomes (PRO), Quality of life, Preterm birth, Abdominal cerclage
- Medical subject headings
- Uterine Cervical Incompetence, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal cerclage (open or laparoscopic)Procedure or surgery
Participants who have had either an open transabdominal cerclage or laparoscopic abdominal cerclage procedure performed.
| Study group | Role | What they receive |
|---|---|---|
| Transabdominal cerclage | Participants with a transabdominal cerclage and subsequent birth Receives: 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. Receives: Procedure: Abdominal cerclage (open or laparoscopic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At enrollment
Secondary outcomes (6)
Pelvic pain
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
Measured: At enrollment
Foreign body sensation
This issue was conceptualized as awareness and reminding of having the cerclage. Consists of two qualitatively pilot tested ad hoc questions.
Measured: At enrollment
Trust in the cerclage
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.
Measured: At enrollment
Bladder discomfort
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)
Measured: At enrollment
Sexual health
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)
Measured: At enrollment
SF - 36 QOL
- 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)
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start5 Mar 2025
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerclage, CervicalStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875401
- Sponsor's protocol ID
- 1-45-70-80-24
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 42549482
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Patient-Reported Maternal Outcomes Following Abdominal Cerclage for the Prevention of Preterm Birth
- ClinicalTrials.gov ID
- NCT06875401
- Acronym / sponsor ID
- 1-45-70-80-24
- Conditions
- Cerclage, Cervical, Cervical Insufficiency
- Keywords
- Patient reported outcomes (PRO), Quality of life, Preterm birth, Abdominal cerclage
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transabdominal cerclage | – | Procedure: Abdominal cerclage (open or laparoscopic)Participants with a transabdominal cerclage and subsequent birth |
| 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 | – | Procedure: Abdominal cerclage (open or laparoscopic)Participants who underwent the abdominal cerclage procedure, but did not become pregnant after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Transabdominal cerclage
Key exclusion criteria (1 listed)
- Most recent birth within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal cerclage (open or laparoscopic)Participants who have had either an open transabdominal cerclage or laparoscopic abdominal cerclage procedure performed. | Procedure or surgery | Transabdominal cerclage, Women with a transabdominal cerclage and no subsequent birth |
Primary outcome
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.
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 42549482Hansen 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.
- Individual participant dataSharing planned: Undecided
Related trials for Cerclage, Cervical
Not yet recruitingPhase 4
Azithromycin for Cerclage Prophylaxis
Cervical Insufficiency
Recruiting
LATe Cerclage in High-risk Pregnancies (LATCH)
Premature Birth
Recruiting
Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix
Preterm
Not yet recruiting
Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal
Preterm Delivery, Cervical Cerclage
Recruiting
Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies
Preterm Birth, Short Cervix
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerclage, Cervical and Cervical Insufficiency, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Health Perception scale - SF-36 (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06875401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.