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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04786626
Acronym
CSD
Enrollment
60
Registered
2021-03-08
Start date
2021-03-20
Completion date
2023-12-31
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasound Evaluation

Keywords

ultrasound, cesarean scar defects, vaginal repair, resistance index

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.

Interventions

DIAGNOSTIC_TESTUltrasound evaluation

After vaginal, 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

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ultrasound EvaluationChange from Baseline Systolic Blood Pressure at 6 monthsresistance index (RI) of the uterine arteries

Secondary

MeasureTime frameDescription
the size of CSDon Days: 0, 2, 30, 60 and 90the length in millimeters, the width in millimeters and the depth in millimeters of CSD
the TRM of scaron Days: 0, 2, 30, 60 and 90the TRM of scar

Other

MeasureTime frameDescription
reproductive information2 yearsreproductive information by questionnaire, including abortion, delivery, childbirth, etc.

Countries

China

Contacts

Primary ContactXipeng Wang, Doctor
wangxipeng@xinhuamed.com.cn86-021-25078999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026