Cesarean Scar DefectNCT06529952
Comparative Study Between Hormonal and Hysteroscopic Management of Cesarean Scar Defect
A study testing hysteroscopic surgery by resection and endocoagulation, hysteroscopic surgery by endocoagulation only and hormonal treatment in people with Cesarean Scar Defect, run by Alexandria University at 2 sites in Egypt.
Trial summary
Up to 70% of women who have had a previous caesarean section experience uterine niche, with 30% having symptoms. Prevalence rates vary between 24-70% using transvaginal ultrasonography and 56-84% using gel/saline instillation sonohysterography. Read more about this study
- Who is it for?
- Ages 25 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Scar Defect
- What is being tested?
- hysteroscopic surgery by resection and endocoagulation, hysteroscopic surgery by endocoagulation only and hormonal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Feb 2022to 20 Feb 2023
- Phase
- Interventional
- 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 25 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women with age ranging from 25 to 42 years,
- previous cesarean section,
- presence of a cesarean scar defect on ultrasound with a residual myo3metrium of > 1.5 mm.
Who cannot join
- any contraindications of hysteroscopy as an active pelvic infection, active genital herpes,
- Contraindications to hormonal treatment as medical conditions like breast cancer, history of deep venous thrombosis, Previous arterial thrombosis, pulmonary embolism, active liver disease, use of rifampicin, familial hyperlipidemia, pregnancy,
- patient refusal
- Any Other causes of abnormal uterine bleeding as polyp, adenomyosis. leiomyoma, malignancy, coagulopathy. and ovulatory disorders.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
El shatby hospital Alexandria university
Alexandria
Tamer
Alexandria
About this study
Official title: Comparative Study Between Hysteroscopic Management of Cesarean Scar Defect and Hormonal Treatment. A Randomized Controlled Trial
Up to 70% of women who have had a previous caesarean section experience uterine niche, with 30% having symptoms. Prevalence rates vary between 24-70% using transvaginal ultrasonography and 56-84% using gel/saline instillation sonohysterography. Classification involves the ratio of myometrial thickness at the scar to adjacent myometrium, with severe deficiency defined by a ratio of ≤50%. Dehiscence is defined as at least 80% myometrial thinning.
The aim of this work was to compare between the effectiveness of two different techniques of hysteroscopic ablation of cesarean scar defect and hormonal treatment to improve abnormal uterine bleeding and pelvic pain localized in the suprapubic area associated with isthmocele.
Read the detailed description
The study include 78 women diagnosed with abnormal uterine bleeding (AUB). All cases were subjected for complete history taking, complete general and gynaecological examination, vaginal ultrasonography (TVUS) to confirm niche and exclude other pathologies. The women were randomly divided by1:1:1 ratio into three equal groups using double blind method with closed envelopes
Group A: include 26 patients subjected to hysteroscopic surgery in the form of resection of lower edge, resection of upper edge and endocoagulation to fulgurate the visible dilated blood vessels or endometrial-like glands inside the base of the niche by using a roller ball resectoscope with monopolar electrical current and glycine as distension media.
Group B: include 26 patients subjected to hysteroscopic endocoagulation to the base of the niche by roller ball using monopolar electrical current and glycine as distension media.
Group C: include 26 patients received hormonal treatment in the form of 3rd generation combined oral contraceptive pills in a cyclic manner for 6 months.
Follow up was done after 1, 3, 6 months, by TVUS to exclude presence of symptoms of abnormal uterine bleeding (AUB) and to assess different outcome measures including presence or absence of intermenstrual spotting, presence or absence of postcoital bleeding, presence or absence of Pelvic tenderness or dyspareunia
- Conditions
- Cesarean Scar Defect
- Being tested
- hysteroscopic surgery by resection and endocoagulation, hysteroscopic surgery by endocoagulation only, hormonal treatment
- Keywords
- cesarean scar defect, hormonal treatment, hysterscopic treatment, endocoagulation, hysteroscopic resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysteroscopic surgery by resection and endocoagulationProcedure or surgery
resection of lower edge, resection of upper edge and endocoagulation
hysteroscopic surgery by endocoagulation onlyProcedure or surgery
hysteroscopic endocoagulation to the base of the niche by roller ball
hormonal treatmentDrug
using 3rd generation contraceptive pills
| Study group | Role | What they receive |
|---|---|---|
| Hysteroscopic resection | Experimental | 26 patients subjected to hysteroscopic surgery in the form of resection of lower edge, resection of upper edge and endocoagulation to fulgurate the visible dilated blood vessels or endometrial-like glands inside the base of the niche by using a roller ball resectoscope with monopolar electrical current and glycine as distension media. Receives: Procedure: hysteroscopic surgery by resection and endocoagulation |
| hysteroscopic endocoagulation | Experimental | include 26 patients subjected to hysteroscopic endocoagulation to the base of the niche by roller ball using monopolar electrical current and glycine as distension media. Receives: Procedure: hysteroscopic surgery by endocoagulation only |
| hormonal treatment | Experimental | 26 patients received hormonal treatment in the form of 3rd generation combined oral contraceptive pills in a cyclic manner for 6 months. Receives: Drug: hormonal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence or absence of intermenstrual spotting,
improvement of intermenstrual spotting in group a and B from 1 st month , and improvment in all groups after 6 months
Measured: 6 months
presence or absence of postcoital bleeding
improvement of postcoital bleeding in all groups after 6 months
Measured: 6 months
presence or absence of pelvic tenderness or dyspareunia
improvement of postcoital bleeding in all groups after 6 months
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 posted31 Jul 2024
- Study start10 Feb 2022
- Primary completion1 Dec 2022
- Study completion20 Feb 2023
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 Alexandria UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the study include three groups group 1: hysterostopic resection of the upper and lower edges of the CSD then endocoagulation group2: hysteroscopic endocoagulation group3: hormonal treatment by 3rd generation contraceptive pills for 6 months
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529952
- Sponsor's protocol ID
- 0107228
- Status last verified
- Jun 2022
- First submitted
- 27 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Hysteroscopic Management of Cesarean Scar Defect and Hormonal Treatment. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06529952
- Acronym / sponsor ID
- 0107228
- Conditions
- Cesarean Scar Defect
- Keywords
- cesarean scar defect, hormonal treatment, hysterscopic treatment, endocoagulation, hysteroscopic resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 31 Jul 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.
Up to 70% of women who have had a previous caesarean section experience uterine niche, with 30% having symptoms. Prevalence rates vary between 24-70% using transvaginal ultrasonography and 56-84% using gel/saline instillation sonohysterography. Classification involves the ratio of myometrial thickness at the scar to adjacent myometrium, with severe deficiency defined by a ratio of ≤50%. Dehiscence is defined as at least 80% myometrial thinning.
The aim of this work was to compare between the effectiveness of two different techniques of hysteroscopic ablation of cesarean scar defect and hormonal treatment to improve abnormal uterine bleeding and pelvic pain localized in the suprapubic area associated with isthmocele.
Detailed description
The study include 78 women diagnosed with abnormal uterine bleeding (AUB). All cases were subjected for complete history taking, complete general and gynaecological examination, vaginal ultrasonography (TVUS) to confirm niche and exclude other pathologies. The women were randomly divided by1:1:1 ratio into three equal groups using double blind method with closed envelopes
Group A: include 26 patients subjected to hysteroscopic surgery in the form of resection of lower edge, resection of upper edge and endocoagulation to fulgurate the visible dilated blood vessels or endometrial-like glands inside the base of the niche by using a roller ball resectoscope with monopolar electrical current and glycine as distension media.
Group B: include 26 patients subjected to hysteroscopic endocoagulation to the base of the niche by roller ball using monopolar electrical current and glycine as distension media.
Group C: include 26 patients received hormonal treatment in the form of 3rd generation combined oral contraceptive pills in a cyclic manner for 6 months.
Follow up was done after 1, 3, 6 months, by TVUS to exclude presence of symptoms of abnormal uterine bleeding (AUB) and to assess different outcome measures including presence or absence of intermenstrual spotting, presence or absence of postcoital bleeding, presence or absence of Pelvic tenderness or dyspareunia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- the study include three groups group 1: hysterostopic resection of the upper and lower edges of the CSD then endocoagulation group2: hysteroscopic endocoagulation group3: hormonal treatment by 3rd generation contraceptive pills for 6 months
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopic resection | Experimental | Procedure: hysteroscopic surgery by resection and endocoagulation26 patients subjected to hysteroscopic surgery in the form of resection of lower edge, resection of upper edge and endocoagulation to fulgurate the visible dilated blood vessels or endometrial-like glands inside the base of the niche by using a roller ball resectoscope with monopolar electrical current and glycine as distension media. |
| hysteroscopic endocoagulation | Experimental | Procedure: hysteroscopic surgery by endocoagulation onlyinclude 26 patients subjected to hysteroscopic endocoagulation to the base of the niche by roller ball using monopolar electrical current and glycine as distension media. |
| hormonal treatment | Experimental | Drug: hormonal treatment26 patients received hormonal treatment in the form of 3rd generation combined oral contraceptive pills in a cyclic manner for 6 months. |
Who may qualify
- Ages
- 25 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women with age ranging from 25 to 42 years,
- previous cesarean section,
- presence of a cesarean scar defect on ultrasound with a residual myo3metrium of > 1.5 mm.
Key exclusion criteria (4 listed)
- any contraindications of hysteroscopy as an active pelvic infection, active genital herpes,
- Contraindications to hormonal treatment as medical conditions like breast cancer, history of deep venous thrombosis, Previous arterial thrombosis, pulmonary embolism, active liver disease, use of rifampicin, familial hyperlipidemia, pregnancy,
- patient refusal
- Any Other causes of abnormal uterine bleeding as polyp, adenomyosis. leiomyoma, malignancy, coagulopathy. and ovulatory disorders.
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 |
|---|---|---|
| hysteroscopic surgery by resection and endocoagulationresection of lower edge, resection of upper edge and endocoagulation | Procedure or surgery | Hysteroscopic resection |
| hysteroscopic surgery by endocoagulation onlyhysteroscopic endocoagulation to the base of the niche by roller ball | Procedure or surgery | hysteroscopic endocoagulation |
| hormonal treatmentusing 3rd generation contraceptive pills | Drug | hormonal treatment |
Primary outcome
presence or absence of intermenstrual spotting,
Time frame: 6 months
improvement of intermenstrual spotting in group a and B from 1 st month , and improvment in all groups after 6 months
presence or absence of postcoital bleeding
Time frame: 6 months
improvement of postcoital bleeding in all groups after 6 months
presence or absence of pelvic tenderness or dyspareunia
Time frame: 6 months
improvement of postcoital bleeding in all groups after 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 31 Jul 2024.
- Individual participant dataSharing planned: No
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Platelet Rich Plasma for Uterine Scar
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Cesarean Scar Defect: a Prospective, Observational Study.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hysteroscopic surgery by resection and endocoagulation, hysteroscopic surgery by endocoagulation only and hormonal treatment in people with Cesarean Scar Defect, run by Alexandria University at 2 sites in Egypt.
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 3 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: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
presence or absence of intermenstrual spotting, (time frame: 6 months). The study lists 3 primary outcomes in all. 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 31 Jul 2024.