Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy

• Sponsor: Shanghai First Maternity and Infant Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02865655
• Collaborator: (none)
• Enrollment: 60
• Location: 1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section Scar	Procedure: Hysteroscopic

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy
• Study Start Date: Jun 1, 2016
• Anticipated Primary Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Cesarean Section Scar Evaluation by TVU and MRI [2015.12-2016.7]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University	Shanghai	Shanghai	China

Sponsors and Collaborators

• Shanghai First Maternity and Infant Hospital

Investigators

• Study Chair: Xipeng Wang, Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai First Maternity and Infant Hospital
• ClinicalTrials.gov Identifier: NCT02865655
• Other Study ID Numbers: ShanghaiFMIH-CSD
• First Posted: Aug 12, 2016
• Last Update Posted: Aug 12, 2016
• Last Verified: Aug 1, 2016

Study Results

No Results Posted as of Aug 12, 2016