Cesarean Section ScarNCT02865655
Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy
An observational study of Cesarean Section Scar, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial summary
To apply an existing diagnostic imaging test (saline infusion sonohysterography by Hysteroscopic) to characterize the "filling defect" of a previous cervical cesarean delivery scar in the nonpregnant uterus Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cesarean Section Scar
- What is being tested?
- Hysteroscopic
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jun 2018
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: cesarean section diverticula patients in our hospital from 2016 to Dec 2018.The diagnosis was confirmed on the basis of medical history (at least one C-section), clinical symptoms (post¬menstrual spotting, no significant change of cycle before and after C-section),transvaginal ultrasonography (TVU), and mag¬netic resonance imaging (MRI) findings
Who may be able to join
- cesarean section diverticula patients in our hospital from 2016 to Dec 2018.The diagnosis was confirmed on the basis of medical history (at least one C-section), clinical symptoms (post¬menstrual spotting, no significant change of cycle before and after C-section),transvaginal ultrasonography (TVU), and mag¬netic resonance imaging (MRI) findings
Who cannot join
- 1) irregular menstrual cycle before cesar¬ean section; 2) previous placement of an intrauterine contracep¬tive device; and 3) presence of another organic uterine pathology responsible for abnormal uterine bleeding examined by hysteroscopy, such as endome-trial hyperplasia, endometrial polyps, malignancy, or submucosal myomas
Trial locations and contacts
1 site in 1 country.
Xipeng Wang contact
Xingchen Zhou contact
China1 site, 1 recruiting
- Recruiting
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
Shanghai, Shanghai Municipality
Xipeng Wang, Xipengwang@hotmail.com
About this study
To apply an existing diagnostic imaging test (saline infusion sonohysterography by Hysteroscopic) to characterize the "filling defect" of a previous cervical cesarean delivery scar in the nonpregnant uterus
- Conditions
- Cesarean Section Scar
- Being tested
- Hysteroscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopicProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CSD-TVU | Cesarean Section Scar Evaluation by TVU | |
| CSD-MRI | Cesarean Section Scar Evaluation by MRI | |
| CSD-MRI with saline | Cesarean Section Scar Evaluation by MRI with saline | |
| CSD-Hysteroscopic | Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy Receives: Procedure: Hysteroscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean Section Scar Evaluation by TVU and MRI
Measured: 2015.12-2016.7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ScarStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xipeng Wang, Study chair, Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865655
- Sponsor's protocol ID
- ShanghaiFMIH-CSD
- Status last verified
- Aug 2016
- First submitted
- 10 Aug 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy
- ClinicalTrials.gov ID
- NCT02865655
- Acronym / sponsor ID
- ShanghaiFMIH-CSD
- Conditions
- Cesarean Section Scar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- First posted
- 12 Aug 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.
To apply an existing diagnostic imaging test (saline infusion sonohysterography by Hysteroscopic) to characterize the "filling defect" of a previous cervical cesarean delivery scar in the nonpregnant uterus
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CSD-TVU | – | –Cesarean Section Scar Evaluation by TVU |
| CSD-MRI | – | –Cesarean Section Scar Evaluation by MRI |
| CSD-MRI with saline | – | –Cesarean Section Scar Evaluation by MRI with saline |
| CSD-Hysteroscopic | – | Procedure: HysteroscopicCesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- cesarean section diverticula patients in our hospital from 2016 to Dec 2018.The diagnosis was confirmed on the basis of medical history (at least one C-section), clinical symptoms (post¬menstrual spotting, no significant change of cycle before and after C-section),transvaginal ultrasonography (TVU), and mag¬netic resonance imaging (MRI) findings
Key inclusion criteria (1 listed)
- cesarean section diverticula patients in our hospital from 2016 to Dec 2018.The diagnosis was confirmed on the basis of medical history (at least one C-section), clinical symptoms (post¬menstrual spotting, no significant change of cycle before and after C-section),transvaginal ultrasonography (TVU), and mag¬netic resonance imaging (MRI) findings
Key exclusion criteria (1 listed)
- 1) irregular menstrual cycle before cesar¬ean section; 2) previous placement of an intrauterine contracep¬tive device; and 3) presence of another organic uterine pathology responsible for abnormal uterine bleeding examined by hysteroscopy, such as endome-trial hyperplasia, endometrial polyps, malignancy, or submucosal myomas
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 | Procedure or surgery | CSD-Hysteroscopic |
Primary outcome
Cesarean Section Scar Evaluation by TVU and MRI
Time frame: 2015.12-2016.7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
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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.
Xipeng Wang contact
Xingchen Zhou contact
Xipeng Wang study chair
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
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 Scar, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 12 Aug 2016. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xipeng Wang (xipengwang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean Section Scar Evaluation by TVU and MRI (time frame: 2015.12-2016.7). 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 12 Aug 2016.