Endometrium Microbiome Alterations in Cesarean Section Diverticula Before and After Transvaginal Repair Surgery

Cesarean Section Complications Clinical Trial

Official title:

Endometrium Microbiome Alterations in Cesarean Section Diverticula Before and After Transvaginal Repair Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04847154
• Other study ID #: XH-21-003
• Status: Not yet recruiting
• Start date: April 12, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study compares the microbiome differences in the endometrium between normal people and patients with uterine diverticula after cesarean section and aims to discover the essential microbes and their metabolites that highly associate with the repair of myometrium through metagenomics and metabolomics. It verifies that flora disorder in the endometrium is the important cause of poor uterine repair after cesarean section. Then these patients with uterine diverticula receive the transvaginal repair surgery. Through the follow-up with them, we gain the microbiome differences of the endometrium before and after the surgery and show the validity of transvaginal repair surgery in the level of microbiome and metabolism.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

have one cesarean delivery, have intermenstrual spotting after the cesarean section or Residual muscle thickness was less than 3.0 mm at the preoperative stage underwent magnetic resonance imaging and transvaginalultrasound to evaluate the size of the defect and the Residual muscle thickness before surgery have vaginal repair of Cesarean Section Diverticula write consent for operation.

Exclusion Criteria:

have a history of endocrine disorders have coagulation disorders use of intrauterine devices have sub-mucous myoma have endometrial diseases have endometrial cysts, uterine fibroids, and adenomyosis

Related Conditions & MeSH terms

• Cesarean Section Complications
• Diverticulum

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Endometrium Microbiome	analysis the microbiome differences in the endometrium between normal people and patients with uterine diverticula after cesarean section and after vaginal repair surgery	In the 7th day of the period