Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy

NCT02865655 | Unknown

• 1 other identifier: ShanghaiFMIH-CSD
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Cesarean Section Scar

Outcome Measures

Primary Outcomes (1)

• Cesarean Section Scar Evaluation by TVU and MRI

  2015.12-2016.7

Study Arms (4)

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

Hysteroscopic PROCEDURE

CSD-Hysteroscopic

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

Study Sites (1)

Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

Hysteroscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Xipeng Wang

  Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

  STUDY CHAIR

Central Study Contacts

Xipeng Wang

CONTACT

xipengwang@hotmail.com

Xingchen Zhou

CONTACT

z_xc8@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 12, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Last Updated: August 12, 2016

Record last verified: 2016-08

Locations

CN (1)