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

Hysteroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04096677
• Other study ID #: Post cesarean scar defect
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: October 30, 2019

Study information

• Verified date: September 2019
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Yuqing Chen, MD
• Phone: 13724067575
• Email: fangchenyq[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cicatrix
• Hysteroscopy
• Post Cesarean Scar Defect

Intervention

Procedure:
• hysteroscpy

Locations

Country	Name	City	State
China	First affiliated hospital of SUN Yat-Sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of SunYetSen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with a less postoperative menstruation	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.	6 months
Primary	Number of Participants being a pregnant	Follow-up carried out 1 year after the initial operation, postoperative pregnancy with a history of infertility preoperatively	1 year