Cesarean Scar DefectDICENCT02717312
Prevalence, Risk Factors and Consequences Related to Cesarean Scar Defect (Defect in Cesarean Scar)
An observational study of Cesarean Scar Defect, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The rates of cesarean section (CS) are rising all over the world. Worldwide the number of CS is millions every year. CS is one of the most frequently performed operation for women. As a consequence many women have a scar in their uterus. Cesarean scar may be associated with complications in later pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Scar Defect
- How many people
- 400 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2016to May 2021
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women undergoing cesarean section
Who may be able to join
- Women who gives birth by cesarean section whether it will be an elective surgery or an emergency surgery during labour
Who cannot join
- Uterus anomaly or von Willebrand disease
- Informed consent not provided
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Defect in Cesarean Scar: A Prospective Study of Prevalence, Risk Factors and Impact on Menstrual Disorders and Quality of Life
The rates of cesarean section (CS) are rising all over the world. Worldwide the number of CS is millions every year. CS is one of the most frequently performed operation for women. As a consequence many women have a scar in their uterus. Cesarean scar may be associated with complications in later pregnancies. In recent years there have also been a few reports indicating that cesarean scar could potentially be associated with menstrual disorders and infertility. The impact of cesarean scar defect on long term welfare or quality of life is not clear.
In some women with a history of CS it is possible to recognise a defect in the site of previous uterotomy years after the performed CS by sonographic examination. This defect in the scar, also called as a niche, is a consequence of incomplete healing of the scar in the lower part of uterus. To date there is uncertainty relating to the factors that lead to poor healing of cesarean scar. Also impact of cesarean scar defect on later well-being and later pregnancies are not properly known.
Read more
The purpose of this study is to investigate the prevalence and the risk factors of cesarean scar defect. Also the impact of cesarean scar defect on women´s menstrual health, fertility, further deliveries and quality of life will be investigated.
This study is a prospective observational cohort study. Women at the age of 18-45 years who will give birth by elective or emergency CS will be asked to participate. Women are recruited within two days of CS. Women with known uterus anomaly or von Willebrand disease will be excluded.
The prevalence of scar defect will be evaluated by transvaginal sonography and contrast-enhanced sonohysterography using saline infusion. Both 2-dimensional and 3-dimensional sonography will be used. Sonographic evaluation will take place 6 months after the CS.
The following definition for CS scar defect will be used: myometrial discontinuity with a depth of ≥2 mm at the site of cesarean scar that communicates with the uterine or cervical cavity as seen on transvaginal sonography with or without saline infusion.
The prevalence of menstrual disorders will be evaluated 12 months after the CS. The subjects will be asked to report the number of menstrual bleeding days once a month during 3 consecutive months. Postmenstrual spotting is defined as ≥2 days of brownish discharge at the end of menstruation with total bleeding days of ≥7 or non-cyclic bleeding not related to menstruation.
- Conditions
- Cesarean Scar Defect
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between cesarean scar defect and post menstrual spotting
Postmenstrual spotting is defined as ≥2 days of brownish discharge at the end of menstrual bleeding with total bleeding days ≥7 or inter menstrual non-cyclic bleeding not related to menstruation.
Measured: 15 months
Secondary outcomes (4)
Quality of life related to cesarean scar defect
Quality of life related to cesarean scar defect will be assessed by using rand36 score.
Measured: 10 years
Association between cesarean scar and adverse pregnancy outcome
Adverse pregnancy outcome includes spontaneous abortion, cesarean scar pregnancy, uterine rupture in later pregnancy and the rate of vaginal birth/cesarean section in later pregnancies.
Measured: 10 years
Prevalence of cesarean scar defect measured by sonography
Number of participants with cesarean scar defect. Cesarean scar defect is defined as myometrial discontinuity with a depth of ≥2 mm at the site of cesarean scar that communicates with the uterine or cervical cavity as seen on transvaginal sonography with or without saline infusion.
Measured: 6 months
Impact of cervical opening at the time of cesarean section on the prevalence of cesarean scar defect.
Association between cervical opening at the time of operation (cm) and detected cesarean scar defect (6 months after the operation).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2017
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Scar DefectStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- 400 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- City of Tampere, Finnish Medical Foundation
- Responsible party
- Sponsor
- Investigators
- Synnöve Staff, MC PhD, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717312
- Sponsor's protocol ID
- R15104
- Acronym
- DICE
- Status last verified
- Sep 2021
- First submitted
- 9 Mar 2016
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defect in Cesarean Scar: A Prospective Study of Prevalence, Risk Factors and Impact on Menstrual Disorders and Quality of Life
- ClinicalTrials.gov ID
- NCT02717312
- Acronym / sponsor ID
- DICE / R15104
- Conditions
- Cesarean Scar Defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- City of Tampere, Finnish Medical Foundation
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 23 Mar 2016 (estimated)
- 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.
The rates of cesarean section (CS) are rising all over the world. Worldwide the number of CS is millions every year. CS is one of the most frequently performed operation for women. As a consequence many women have a scar in their uterus. Cesarean scar may be associated with complications in later pregnancies. In recent years there have also been a few reports indicating that cesarean scar could potentially be associated with menstrual disorders and infertility. The impact of cesarean scar defect on long term welfare or quality of life is not clear.
In some women with a history of CS it is possible to recognise a defect in the site of previous uterotomy years after the performed CS by sonographic examination. This defect in the scar, also called as a niche, is a consequence of incomplete healing of the scar in the lower part of uterus. To date there is uncertainty relating to the factors that lead to poor healing of cesarean scar. Also impact of cesarean scar defect on later well-being and later pregnancies are not properly known.
The purpose of this study is to investigate the prevalence and the risk factors of cesarean scar defect. Also the impact of cesarean scar defect on women´s menstrual health, fertility, further deliveries and quality of life will be investigated.
This study is a prospective observational cohort study. Women at the age of 18-45 years who will give birth by elective or emergency CS will be asked to participate. Women are recruited within two days of CS. Women with known uterus anomaly or von Willebrand disease will be excluded.
The prevalence of scar defect will be evaluated by transvaginal sonography and contrast-enhanced sonohysterography using saline infusion. Both 2-dimensional and 3-dimensional sonography will be used. Sonographic evaluation will take place 6 months after the CS.
The following definition for CS scar defect will be used: myometrial discontinuity with a depth of ≥2 mm at the site of cesarean scar that communicates with the uterine or cervical cavity as seen on transvaginal sonography with or without saline infusion.
The prevalence of menstrual disorders will be evaluated 12 months after the CS. The subjects will be asked to report the number of menstrual bleeding days once a month during 3 consecutive months. Postmenstrual spotting is defined as ≥2 days of brownish discharge at the end of menstruation with total bleeding days of ≥7 or non-cyclic bleeding not related to menstruation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women undergoing cesarean section
Key inclusion criteria (1 listed)
- Women who gives birth by cesarean section whether it will be an elective surgery or an emergency surgery during labour
Key exclusion criteria (2 listed)
- Uterus anomaly or von Willebrand disease
- Informed consent not provided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between cesarean scar defect and post menstrual spotting
Time frame: 15 months
Postmenstrual spotting is defined as ≥2 days of brownish discharge at the end of menstrual bleeding with total bleeding days ≥7 or inter menstrual non-cyclic bleeding not related to menstruation.
4 secondary outcomes
Quality of life related to cesarean scar defect
Time frame: 10 years
Association between cesarean scar and adverse pregnancy outcome
Time frame: 10 years
Prevalence of cesarean scar defect measured by sonography
Time frame: 6 months
Impact of cervical opening at the time of cesarean section on the prevalence of cesarean scar defect.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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Cesarean Scar Defect: a Prospective, Observational Study.
Niche
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Two Dimensional Versus Three Dimensional Transvaginal U/S With or Without SIS
Scar Niche
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. This study is not recruiting at the moment.
Synnöve Staff, MC PhD study director
Tampere University Hospital
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 Cesarean Scar Defect, run by Tampere University Hospital at 1 site in Finland.
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 2 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: finished, as of the sponsor's last update on 29 Sep 2021. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Association between cesarean scar defect and post menstrual spotting (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2021.