IsthmoceleNCT06708234
Frequency of Isthmocele Following Single- Vs Double-layer Uterine Closure.
An observational study of Isthmocele, run by Lorenza Driul at 1 site in Italy.
Trial summary
The main objective of this study is to compare the frequency of isthmocele after caesarean section according to the type of hysteroraffia performed (single or double layer suture). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Isthmocele
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 9 May 2024to Nov 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
- No healthy volunteers
- Adult, Older adult
Study population: patients attending the Friuli Centrale University Health Authority - Obstetrics and Gynaecology of Tolmezzo
Who may be able to join
- Patients undergoing elective or emergency/emergency caesarean section at the centres involved.
Who cannot join
- Age <18 years;
- Pregnant women at the time of ultrasound assessment;
- Refusal to perform transvaginal ultrasound;
- Type of hysterorrhaphy performed during surgery not known;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ostetrica e Ginecologica Udine
Udine, Udine, 33100
Lorenza Driul, +00393358385138, lorenza.driul@uniud.it
Silvia Zermano, +00393468624022, silvia.zermano@asufc.sanita.fvg.it
About this study
Official title: Frequency of Isthmocele Following Single- Vs Double-layer Uterine Closure. a Prospective and Retrospective Multicenter Observational Study
The main objective of this study is to compare the frequency of isthmocele after caesarean section according to the type of hysteroraffia performed (single or double layer suture).
Read the detailed description
The effects of caesarean sections on maternal health have long been known and are an issue of great interest and concern every time these epidemiological data are analysed. Among the late complications reported in the literature, several publications have analysed the correlation between the presence of abnormal uterine bleeding in the postmenstrual phase and the presence of a defect in the anterior wall of the uterine isthmus at the site of a previous caesarean section scar. Although this clinical picture, termed isthmocele, has been known for some time, its aetiopathogenesis and implications have so far been rather underestimated. The isthmocele is a saccated diverticulum of the anterior wall of the uterus in continuity with the uterine cavity, which forms at the level of the isthmus, at the site of a previous hysterectomy by caesarean section. This wall defect can lead to symptoms such as menorrhagia, abnormal uterine bleeding, pelvic pain and dysmenorrhoea. pelvic pain and dysmenorrhoea, and can also cause 'scar pregnancy' and secondary infertility. This complication occurs in more than 50% of women who undergo a caesarean section, and this percentage increases in relation to the number of previous caesarean sections. Currently, treatment options include conservative treatment, based on combined oestrogen-progestin therapy, and surgical treatment, based on hysteroscopic, laparoscopic or transvaginal repair. The choice is made on the basis of the extent of the defect, presence of symptoms, concomitant secondary infertility and desire for offspring. Although the possibility of treating isthmocele exists, in recent years interest has shifted to the possibility of preventing the occurrence of this complication. Among the risk factors recognised to date are include uterine position in retroversion and multiple caesarean sections. However, they may also contribute. However, factors such as a low uterine incision, incomplete closure of the hysterotomy, the appearance of early uterine wall adhesions and a genetic predisposition of the patient can also contribute to the development of a isthmus. A study of the risk factors associated with the occurrence of this problem showed that the technique of suturing is the most modifiable risk factor. In this regard, some studies have suggested that a double-layer closure of the uterine breach reduces the occurrence of isthmocele and increases the residual myometrial thickness, but systematic reviews of the literature have found no difference between patients undergoing single- and double-layer hysteroraffia, while they have shown that hollow sutures may lead to a larger isthmocele and a higher risk of uterine rupture, without providing any substantial haemostatic benefit. substantial haemostatic benefits. To date, there are no guidelines identifying the optimal time to perform evaluation of the cesarean section scar and diagnose the possible presence of a isthmocele. The isthmocele presents itself sonographically as a triangular anechogenic space, at least 2 mm deep, in the context of the anterior uterine wall, at the presumed site of the caesarean section scar with the base communicating with the uterine cavity. It should not be confused with the caesarean section scar itself, which appears as a hypercogenic line at the presumed site or with similar echogenicity to the surrounding myometrium. Most authors have focused on measuring the depth of the isthmocele, the size of the residual myometrial thickness and only a few have distinguished the extent of the defect into major or minor on the basis of the percentage of myometrium involved. However, other highly relevant parameters such as defect shape, volume, location, presence of multiple anechogenic areas etc. were not taken into account. The accurate measurement and description of these lesions is becoming increasingly important, for research, for the clinical assessment of gynaecological symptoms and for the planning of possible surgical treatment. For this reason, in 2019 Jordans et al. published an expert consensus 'Delphi protocol' to describe a standardised methodology for ultrasound assessment of isthmocele in patients non-pregnant women.
- Conditions
- Isthmocele
- Keywords
- isthmocele, cesarean section, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| single layer | patients who underwent caesarean section with hysteroraffia performed in single layer | |
| double layer | patients who underwent caesarean section with double-layer hysteroraffia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of isthmocele
The main objective of this study is to compare the frequency of isthmocele after caesarean section according to the type of hysteroraffia performed (single or double layer suture).
Measured: 3-4 months post cesarean section
Secondary outcomes (2)
Different features of isthmocele according to type of hysteroraffia
To determine whether there are differences in isthmocele volume and residual myometrial thickness between patients undergoing hysteroraffia by single or double layer.
Measured: 3-4 months post cesarean section
The role of anamnestic data of patients as risk factor for isthmocele
Assess the impact of anamnestic data as possible risk factors for the development of isthmocele in the population considered.
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 posted27 Nov 2024
- Study start9 May 2024
- Primary completionMay 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsthmoceleStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lorenza Driul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lorenza Driul, University of Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708234
- Sponsor's protocol ID
- 154230
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Isthmocele Following Single- Vs Double-layer Uterine Closure. a Prospective and Retrospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT06708234
- Acronym / sponsor ID
- 154230
- Conditions
- Isthmocele
- Keywords
- isthmocele, cesarean section, ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lorenza DriulUniversity, hospital or other
- Study start
- 9 May 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 27 Nov 2024 (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.
The main objective of this study is to compare the frequency of isthmocele after caesarean section according to the type of hysteroraffia performed (single or double layer suture).
Detailed description
The effects of caesarean sections on maternal health have long been known and are an issue of great interest and concern every time these epidemiological data are analysed. Among the late complications reported in the literature, several publications have analysed the correlation between the presence of abnormal uterine bleeding in the postmenstrual phase and the presence of a defect in the anterior wall of the uterine isthmus at the site of a previous caesarean section scar. Although this clinical picture, termed isthmocele, has been known for some time, its aetiopathogenesis and implications have so far been rather underestimated. The isthmocele is a saccated diverticulum of the anterior wall of the uterus in continuity with the uterine cavity, which forms at the level of the isthmus, at the site of a previous hysterectomy by caesarean section. This wall defect can lead to symptoms such as menorrhagia, abnormal uterine bleeding, pelvic pain and dysmenorrhoea. pelvic pain and dysmenorrhoea, and can also cause 'scar pregnancy' and secondary infertility. This complication occurs in more than 50% of women who undergo a caesarean section, and this percentage increases in relation to the number of previous caesarean sections. Currently, treatment options include conservative treatment, based on combined oestrogen-progestin therapy, and surgical treatment, based on hysteroscopic, laparoscopic or transvaginal repair. The choice is made on the basis of the extent of the defect, presence of symptoms, concomitant secondary infertility and desire for offspring. Although the possibility of treating isthmocele exists, in recent years interest has shifted to the possibility of preventing the occurrence of this complication. Among the risk factors recognised to date are include uterine position in retroversion and multiple caesarean sections. However, they may also contribute. However, factors such as a low uterine incision, incomplete closure of the hysterotomy, the appearance of early uterine wall adhesions and a genetic predisposition of the patient can also contribute to the development of a isthmus. A study of the risk factors associated with the occurrence of this problem showed that the technique of suturing is the most modifiable risk factor. In this regard, some studies have suggested that a double-layer closure of the uterine breach reduces the occurrence of isthmocele and increases the residual myometrial thickness, but systematic reviews of the literature have found no difference between patients undergoing single- and double-layer hysteroraffia, while they have shown that hollow sutures may lead to a larger isthmocele and a higher risk of uterine rupture, without providing any substantial haemostatic benefit. substantial haemostatic benefits. To date, there are no guidelines identifying the optimal time to perform evaluation of the cesarean section scar and diagnose the possible presence of a isthmocele. The isthmocele presents itself sonographically as a triangular anechogenic space, at least 2 mm deep, in the context of the anterior uterine wall, at the presumed site of the caesarean section scar with the base communicating with the uterine cavity. It should not be confused with the caesarean section scar itself, which appears as a hypercogenic line at the presumed site or with similar echogenicity to the surrounding myometrium. Most authors have focused on measuring the depth of the isthmocele, the size of the residual myometrial thickness and only a few have distinguished the extent of the defect into major or minor on the basis of the percentage of myometrium involved. However, other highly relevant parameters such as defect shape, volume, location, presence of multiple anechogenic areas etc. were not taken into account. The accurate measurement and description of these lesions is becoming increasingly important, for research, for the clinical assessment of gynaecological symptoms and for the planning of possible surgical treatment. For this reason, in 2019 Jordans et al. published an expert consensus 'Delphi protocol' to describe a standardised methodology for ultrasound assessment of isthmocele in patients non-pregnant women.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single layer | – | –patients who underwent caesarean section with hysteroraffia performed in single layer |
| double layer | – | –patients who underwent caesarean section with double-layer hysteroraffia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients attending the Friuli Centrale University Health Authority - Obstetrics and Gynaecology of Tolmezzo
Key inclusion criteria (1 listed)
- Patients undergoing elective or emergency/emergency caesarean section at the centres involved.
Key exclusion criteria (4 listed)
- Age <18 years;
- Pregnant women at the time of ultrasound assessment;
- Refusal to perform transvaginal ultrasound;
- Type of hysterorrhaphy performed during surgery not known;
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
Frequency of isthmocele
Time frame: 3-4 months post cesarean section
The main objective of this study is to compare the frequency of isthmocele after caesarean section according to the type of hysteroraffia performed (single or double layer suture).
2 secondary outcomes
Different features of isthmocele according to type of hysteroraffia
Time frame: 3-4 months post cesarean section
The role of anamnestic data of patients as risk factor for isthmocele
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 27 Nov 2024.
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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.
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 Isthmocele, run by Lorenza Driul at 1 site in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 27 Nov 2024. 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 Italy. 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?
Contact Lorenza Driul (+00393358385138, lorenza.driul@uniud.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of isthmocele (time frame: 3-4 months post cesarean section). 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 27 Nov 2024.