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

Ultrasound Evaluation Clinical Trial

— CSD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04786626
• Other study ID #: XH-21-002
• Status: Not yet recruiting
• Start date: March 20, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Xipeng Wang, Doctor
• Phone: 86-021-25078999
• Email: wangxipeng[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Ultrasound Evaluation

Intervention

Diagnostic Test:
• Ultrasound 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

Locations

Country	Name	City	State
China	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	reproductive information	reproductive information by questionnaire, including abortion, delivery, childbirth, etc.	2 years
Primary	Ultrasound Evaluation	resistance index (RI) of the uterine arteries	Change from Baseline Systolic Blood Pressure at 6 months
Secondary	the size of CSD	the length in millimeters, the width in millimeters and the depth in millimeters of CSD	on Days: 0, 2, 30, 60 and 90
Secondary	the TRM of scar	the TRM of scar	on Days: 0, 2, 30, 60 and 90