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

• Conditions: Ultrasound Evaluation

• Registration Number: NCT04786626
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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 Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-08
• Last Update Submitted: 2021-03-19
• Study Start: 2021-03-20
• Last Update Posted: 2021-03-23
• Primary Completion: 2021-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ultrasound Evaluation	Change from Baseline Systolic Blood Pressure at 6 months	resistance index (RI) of the uterine arteries

Secondary Outcome Measures

Name	Time	Method
the size of CSD	on Days: 0, 2, 30, 60 and 90	the length in millimeters, the width in millimeters and the depth in millimeters of CSD
the TRM of scar	on Days: 0, 2, 30, 60 and 90	the TRM of scar

Trial Locations

Locations (1)

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China