Cesarean Section ComplicationsNCT04847154
Endometrium Microbiome Alterations in Cesarean Section Diverticula Before and After Transvaginal Repair Surgery
An observational study of Cesarean Section Complications, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 30 Healthy women with cesarean section without Cesarean Section Diverticula 30 Healthy women with cesarean section with Cesarean Section Diverticula
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
- Conditions
- Cesarean Section Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: In the 7th day of the period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start12 Apr 2021 (estimated)
- Primary completion12 Apr 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847154
- Sponsor's protocol ID
- XH-21-003
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrium Microbiome Alterations in Cesarean Section Diverticula Before and After Transvaginal Repair Surgery
- ClinicalTrials.gov ID
- NCT04847154
- Acronym / sponsor ID
- XH-21-003
- Conditions
- Cesarean Section Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 12 Apr 2021 (estimated)
- Primary completion
- 12 Apr 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 30 Healthy women with cesarean section without Cesarean Section Diverticula 30 Healthy women with cesarean section with Cesarean Section Diverticula
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of Endometrium Microbiome
Time frame: In the 7th day of the period
analysis the microbiome differences in the endometrium between normal people and patients with uterine diverticula after cesarean section and after vaginal repair surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Endometrium Microbiome (time frame: In the 7th day of the period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.