Cesarean Section ComplicationsNCT05911815
Evaluation Of The Diagnostic Role Of Hysterosalpingography In Cesarean Scar Niche Diagnosed By Hysteroscopy
An observational study of Cesarean Section Complications, run by Ain Shams University at 1 site in Egypt.
Trial summary
The term CS niche (defect) describes the presence of a hypoechoic area within the myometrium in the isthmus (lower uterine segment) with discontinuation of myometrium at the site of previous CS. Hysterosalpingography is an important component in the diagnostic evaluation of the infertile woman. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- hysterosalpingography
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Jun 2023
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Study population: All women undergoing Office Hysteroscopy at Early cancer Detection and Gynecological Endoscopy Unit at Ain Shams Maternity Hospital was checked to meet the inclusion criteria for the study.
Who may be able to join
- Age more than 18 years.
- Previous history of cesarean delivery.
- Cesarean scar niche confirmed by Hysteroscopy.
- Premenopausal status
Who cannot join
- Pregnancy.
- Contrast allergy.
- Active pelvic infection.
- Medical history interfering with HSG.
Trial locations and contacts
1 site in 1 country.
About this study
The term CS niche (defect) describes the presence of a hypoechoic area within the myometrium in the isthmus (lower uterine segment) with discontinuation of myometrium at the site of previous CS. Hysterosalpingography is an important component in the diagnostic evaluation of the infertile woman. The number of hysterosalpingography examinations performed has significantly increased in recent years, likely due to the trend for women delaying pregnancy until later in life and the popularity of technical advances achieved in reproductive medicine.The term CS niche (defect) describes the presence of a hypoechoic area within the myometrium in the isthmus (lower uterine segment) with discontinuation of myometrium at the site of previous CS. The main purpose of the study is to evaluate the diagnostic role of HSG to early detect cesarean scar niche. To evaluate diagnostic role of hysterosalpingography (HSG) in cesarean scar niche at Early Cancer Detection and Gynecological Endoscopy Unit at Ain Shams Maternity Hospital within 6 months.
- Conditions
- Cesarean Section Complications
- Being tested
- hysterosalpingography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysterosalpingographyRadiation
hysterosalpingogram (HSG) is an X-ray visualization of the lumen of the uterus and fallopian tubes, which can detect abnormalities including blockage, polyps, and salinities
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean section niche appearance
The ability of hysterosalpingography to detect the cesarean section niche appearance
Measured: baseline, pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Mar 2022
- Primary completion1 Aug 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Saleh, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911815
- Sponsor's protocol ID
- AinG6/2023
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Diagnostic Role Of Hysterosalpingography In Cesarean Scar Niche Diagnosed By Hysteroscopy
- ClinicalTrials.gov ID
- NCT05911815
- Acronym / sponsor ID
- AinG6/2023
- Conditions
- Cesarean Section Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 22 Jun 2023 (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 term CS niche (defect) describes the presence of a hypoechoic area within the myometrium in the isthmus (lower uterine segment) with discontinuation of myometrium at the site of previous CS. Hysterosalpingography is an important component in the diagnostic evaluation of the infertile woman. The number of hysterosalpingography examinations performed has significantly increased in recent years, likely due to the trend for women delaying pregnancy until later in life and the popularity of technical advances achieved in reproductive medicine.The term CS niche (defect) describes the presence of a hypoechoic area within the myometrium in the isthmus (lower uterine segment) with discontinuation of myometrium at the site of previous CS. The main purpose of the study is to evaluate the diagnostic role of HSG to early detect cesarean scar niche. To evaluate diagnostic role of hysterosalpingography (HSG) in cesarean scar niche at Early Cancer Detection and Gynecological Endoscopy Unit at Ain Shams Maternity Hospital within 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All women undergoing Office Hysteroscopy at Early cancer Detection and Gynecological Endoscopy Unit at Ain Shams Maternity Hospital was checked to meet the inclusion criteria for the study.
Key inclusion criteria (4 listed)
- Age more than 18 years.
- Previous history of cesarean delivery.
- Cesarean scar niche confirmed by Hysteroscopy.
- Premenopausal status
Key exclusion criteria (4 listed)
- Pregnancy.
- Contrast allergy.
- Active pelvic infection.
- Medical history interfering with HSG.
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 |
|---|---|---|
| hysterosalpingographyhysterosalpingogram (HSG) is an X-ray visualization of the lumen of the uterus and fallopian tubes, which can detect abnormalities including blockage, polyps, and salinities | Radiation | – |
Primary outcome
Cesarean section niche appearance
Time frame: baseline, pre-intervention
The ability of hysterosalpingography to detect the cesarean section niche appearance
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 22 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
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Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
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 Section Complications, run by Ain Shams University at 1 site 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 4 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 22 Jun 2023. 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 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?
Cesarean section niche appearance (time frame: baseline, pre-intervention). 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 22 Jun 2023.