Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy

NCT ID: NCT02865655

Last Updated: 2016-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Brief Summary

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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

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Conditions

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Cesarean Section Scar

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CSD-TVU

Cesarean Section Scar Evaluation by TVU

No interventions assigned to this group

CSD-MRI

Cesarean Section Scar Evaluation by MRI

No interventions assigned to this group

CSD-MRI with saline

Cesarean Section Scar Evaluation by MRI with saline

No interventions assigned to this group

CSD-Hysteroscopic

Cesarean Section Scar Evaluation by Saline Contrast Sonohysterography During Hysteroscopy

Hysteroscopic

Intervention Type PROCEDURE

Interventions

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Hysteroscopic

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xipeng Wang

Role: STUDY_CHAIR

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

Locations

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

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xipeng Wang

Role: CONTACT

Xingchen Zhou

Role: CONTACT

Facility Contacts

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Xipeng Wang

Role: primary

Other Identifiers

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ShanghaiFMIH-CSD

Identifier Type: -

Identifier Source: org_study_id

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