Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy

Cesarean Section Scar Clinical Trial

Official title:

Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02865655
• Other study ID #: ShanghaiFMIH-CSD
• Status: Recruiting
• Phase: N/A
• First received: August 10, 2016
• Last updated: August 10, 2016
• Start date: June 2016

Study information

• Verified date: August 2016
• Source: Shanghai First Maternity and Infant Hospital
• Contact: Xipeng Wang
• Email: xipengwang[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cesarean Section Scar

Intervention

Procedure:
• Hysteroscopic

Locations

Country	Name	City	State
China	Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean Section Scar Evaluation by TVU and MRI		2015.12-2016.7	Yes