Effects of Hysteroscopy and Transvaginal Surgery on Reproductive Prognosis in Patients With Post Cesarean Scar Defect

NCT ID: NCT04096677

Last Updated: 2019-09-20

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-10-30

Brief Summary

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The study is to compare hysteroscopic repair and transvaginal intervention for correcting uterine defect in patients with post cesarean scar defect (PCSD) and the reproductive prognosis.

Detailed Description

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Post cesarean scar defect (PCSD), refers the lower uterine segment form a reservoir-like pouch during healing process after transverse lower uterine segment cesarean section connected with uterine cavity. The pouch has a valve-like effect, obstructing blood drainage and accumulating blood in depression. These causes may lead to a variety of gynecological disturbances, secondary dysmenorrheal and infertility. Some patients can occur some serious obstetric complications, such as cesarean scar pregnancy and even the rupture of uterus during a subsequent pregnancy. At present, the causes and mechanisms of PCSD are not clear, diagnosis and treatment are not uniform. Surgical methods include abdominal surgery, laparoscopic surgery, transvaginal surgery, hysteroscopic surgery, hysteroscopic with laparoscopic surgery and so on. Hysteroscopic and transvaginal surgery to treating PCSD both are minimally invasive and feasible surgical approach. However, hysteroscopic surgery and transvaginal surgery have not been compared for correcting the uterine defect in patients with PCSD before.

Conditions

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Post Cesarean Scar Defect Hysteroscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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hysteroscopy repair

patients with post cesarean scar defect

hysteroscpy

Intervention Type PROCEDURE

transvaginal repair

patients with post cesarean scar defect

No interventions assigned to this group

Interventions

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hysteroscpy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients had a history of transverse lower uterine segment cesarean section;
* Patients had a previous regular menstruation, while after caesarean section, they occurred prolonged postmentrual bleeding (10-20days)
* Medication failed(contraceptive pills).
* Sex hormone test is normal;
* TVU or hysteroscopy showed a triangular or U-shaped anechoic liquid dark area and on the anterior lower uterine segment in relation to cesarean section scar during menstruation of 7-12 days or hysteroscopic examination showed uterine anterior wall defect like dome changes at isthmus below internal orifice of cervix.

Exclusion Criteria

* Irregular menstrual cycle before cesarean section
* Previous placement of an intrauterine contraceptive device
* Presence of other organic uterine pathology responsible for abnormal uterine bleeding, such as endometrial hyperplasia, polyps or submucosal myomas, cervical cancer, endometrial cancer, etc
* Existence of endocrine diseases, such as dysfunction of pituitary, ovarian, adrenal gland, and thyroid;
* Coagulation dysfunction.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Yuqing Chen

Deputy chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuqing Chen

Role: STUDY_CHAIR

The First Affiliated Hospital of SunYetSen University

Locations

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First affiliated hospital of SUN Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of SunYetSen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuqing Chen, MD

Role: CONTACT

13724067575

Yuqing ChenMD

Role: CONTACT

13724067575

Facility Contacts

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Yuqing Chen, MD

Role: primary

Yuqing Chen, MD

Role: primary

13724067575

Other Identifiers

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Post cesarean scar defect

Identifier Type: -

Identifier Source: org_study_id

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