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

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ClinicalTrials.gov Identifier: NCT04096677
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
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.

Condition or disease Intervention/treatment
Post Cesarean Scar Defect Hysteroscopy Procedure: hysteroscpy

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Effects of Hysteroscopy and Transvaginal Surgery on Reproductive Prognosis and Endometrium Receptive in Patients With Post Cesarean Scar Defect
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Group/Cohort Intervention/treatment
hysteroscopy repair
patients with post cesarean scar defect
Procedure: hysteroscpy
transvaginal repair
patients with post cesarean scar defect



Primary Outcome Measures :
  1. Number of Participants with a less postoperative menstruation [ Time Frame: 6 months ]
    Follow-up carried out 6 months after the initial operation, using the following criteria to evaluate curative effect: Cure: menstrual duration was shortened to no more than 7 days and TVU showed no liquid dark area in scar of lower uterine segment; Improvement: menstrual duration was reduced by more than 2 days, but menstrual duration was still longer than 7days and TVU showed the liquid dark area in lower segment of uterus disappeared or narrowed. Failure: menstrual duration was reduced by less than 2 days or had no obvious change, and TVU showed the liquid dark area in lower segment of uterus did not narrow. Efficiency rate = cure rate + improvement rate.

  2. Number of Participants being a pregnant [ Time Frame: 1 year ]
    Follow-up carried out 1 year after the initial operation, postoperative pregnancy with a history of infertility preoperatively


Biospecimen Retention:   Samples With DNA
endometrium


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients who received hysteroscopy in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of Sun Yat-sen University and were diagnosed with post cesarean scar defect according to the transvaginal ultrasonography or hysteroscopy were recruited into present study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096677


Contacts
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Contact: Yuqing Chen, MD 13724067575 fangchenyq@163.com
Contact: Yuqing ChenMD 13724067575 fangchenyq@163.com

Locations
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China, Guangdong
First affiliated hospital of SUN Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Yuqing Chen, MD         
The First Affiliated Hospital of SunYetSen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Yuqing Chen, MD    13724067575    fangchenyq@163.com   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Chair: Yuqing Chen The First Affiliated Hospital of SunYetSen University
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Responsible Party: Yuqing Chen, Deputy chief physician, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04096677    
Other Study ID Numbers: Post cesarean scar defect
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University:
post cesarean scar defect
hysteroscopy
transvaginal intervention
endometrial receptive
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes