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Status unknownNCT04847154Updated Apr 19, 2021

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

An observational study in Cesarean Section Complications, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-19.

Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
60
Ages
18 Years to 35 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Cesarean Section Complications

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03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

30 Healthy women with cesarean section without Cesarean Section Diverticula 30 Healthy women with cesarean section with Cesarean Section Diverticula

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

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

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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
60 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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

    Time frame: In the 7th day of the period

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Study locations

No study locations are listed for this record.

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Registry details

Key details

Study ID
NCT04847154
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Sponsor
First posted
Apr 19, 2021
Start date
Apr 12, 2021 (estimated)
Primary completion
Apr 12, 2021 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Apr 19, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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