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Clinical Trials/NCT04786626
NCT04786626UnknownNot Applicable

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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country60 target enrollmentStarted: March 20, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Ultrasound Evaluation

Study Overview

Brief Summary

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.

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • have one or more cesarean deliveries,
  • have intermenstrual spotting after the cesarean section or TRM was less than 3.0 mm at the preoperative stage
  • underwent MRI and TVS to evaluate the size of the defect and the TRM before surgery
  • have vaginal repair of CSD
  • 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

Outcomes

Primary Outcomes

Ultrasound Evaluation

Time Frame: Change from Baseline Systolic Blood Pressure at 6 months

resistance index (RI) of the uterine arteries

Secondary Outcomes

  • the size of CSD(on Days: 0, 2, 30, 60 and 90)
  • the TRM of scar(on Days: 0, 2, 30, 60 and 90)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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