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

NCT04786626 | Unknown

• 1 other identifier: XH-21-002
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound Evaluation

Keywords

ultrasound; cesarean scar defects; vaginal repair; resistance index

Outcome Measures

Primary Outcomes (1)

• Ultrasound Evaluation

  resistance index (RI) of the uterine arteries

  Change from Baseline Systolic Blood Pressure at 6 months

Secondary Outcomes (2)

• the size of CSD

  on Days: 0, 2, 30, 60 and 90

• the TRM of scar

  on Days: 0, 2, 30, 60 and 90

Other Outcomes (1)

• reproductive information

  2 years

Interventions

Ultrasound evaluation DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Central Study Contacts

Xipeng Wang, Doctor

CONTACT

86-021-25078999; wangxipeng@xinhuamed.com.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 8, 2021
• Study Start: March 20, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: March 23, 2021

Record last verified: 2021-01

Locations

CN (1)