Ultrasound Evaluation of Uterine Healing After Vaginal Repair of Cesarean Scar Defect (CSD) (CSD)

March 19, 2021 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Cesarean scar defect is one of the complications after cesarean section (CSD). CSD may be further caused many long term complications, such as abnormal uterine bleeding, infertility, uterine scar pregnancy and uterine rupture. Vaginal repair due to CSDs is a minimally invasive and effective method that maintains fertility. The main concern linked to surgery is the quality of healing of the myometrial incision. However, no diagnostic method has yet been widely accepted to assess the healing process. Thus, the authors investigated uterine healing after vaginal repair with two-dimensional (2D) power Doppler ultrasound (PDU) in this study.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The inclusion criteria were CSD patients who had one or more cesarean deliveries, patients who had intermenstrual spotting after the cesarean section or those in which the thickness of the residual myometrium (TRM) was less than 3.0 mm at the preoperative stage.

Patients who had a history of endocrine disorders, coagulation disorders, use of intrauterine devices, sub-mucous myoma, endometrial diseases, endometrial cysts, uterine fibroids, and adenomyosis after cesarean section were excluded from this study.

After vaginal repair, all patients were followed by traditional 2D US scanning and Doppler velocimetry on Days: 0, 2, 30, 60 and 90. Authors evaluated: scar diameter and Doppler velocimetry and resistance index (RI) of the uterine arteries, at their ascending branch.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

CSD patients who had one or more cesarean deliveries, patients who had intermenstrual spotting after the cesarean section or those in which the TRM was less than 3.0 mm at the preoperative stage.

Description

Inclusion Criteria:

  1. have one or more cesarean deliveries,
  2. have intermenstrual spotting after the cesarean section or TRM was less than 3.0 mm at the preoperative stage
  3. underwent MRI and TVS to evaluate the size of the defect and the TRM before surgery
  4. have vaginal repair of CSD
  5. write consent for operation.

Exclusion Criteria:

  1. have a history of endocrine disorders
  2. have coagulation disorders
  3. use of intrauterine devices
  4. have sub-mucous myoma
  5. have endometrial diseases
  6. have endometrial cysts, uterine fibroids, and adenomyosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound Evaluation
Time Frame: Change from Baseline Systolic Blood Pressure at 6 months
resistance index (RI) of the uterine arteries
Change from Baseline Systolic Blood Pressure at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the size of CSD
Time Frame: on Days: 0, 2, 30, 60 and 90
the length in millimeters, the width in millimeters and the depth in millimeters of CSD
on Days: 0, 2, 30, 60 and 90
the TRM of scar
Time Frame: on Days: 0, 2, 30, 60 and 90
the TRM of scar
on Days: 0, 2, 30, 60 and 90

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
reproductive information
Time Frame: 2 years
reproductive information by questionnaire, including abortion, delivery, childbirth, etc.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 20, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • XH-21-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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