Cesarean Section Scar Evaluation by Saline Contrast Sonoh... | NCT02865655

Studies
Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy

NCT02865655

Sponsor

Shanghai First Maternity and Infant Hospital

Status

Unknown status

Last Update Posted

Aug 12, 2016Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Cesarean Section Scar

Interventions

Hysteroscopic

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jun 2018Estimated

Completion Date

Not provided

First Submitted Date

Aug 10, 2016

First Submission Date that Met QC Criteria

Aug 10, 2016

First Posted Date

Aug 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2016

Last Update Posted Date

Aug 12, 2016Estimated

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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	Procedure: Hysteroscopic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hysteroscopic	Procedure		CSD-Hysteroscopic

Measure	Description	Time Frame
Cesarean Section Scar Evaluation by TVU and MRI		2015.12-2016.7

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xipeng Wang	Contact			xipengwang@hotmail.com
Xingchen Zhou	Contact			z_xc8@sina.com

Overall Officials

Name	Affiliation	Role
Xipeng Wang	Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University	Recruiting	Shanghai	Shanghai Municipality		China

Intervention Browse Module

MeSH Terms

ID	Term
D015907	Hysteroscopy

Ancestor Terms

ID	Term
D003944	Diagnostic Techniques, Obstetrical and Gynecological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

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Browse Branches

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