Clinical trial NCT04786626: Ultrasound Evaluation of Uterine Healing After Vaginal Repair of Cesarean Scar Defect (CSD)
Official title: Ultrasound Evaluation of Uterine Healing After Vaginal Repair of Cesarean Scar Defect (CSD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ultrasound Evaluation
Keywords: ultrasound
cesarean scar defects
vaginal repair
resistance index
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ultrasound Evaluation
timeFrame: Change from Baseline Systolic Blood Pressure at 6 months
Secondary outcomes:
measure: the size of CSD
timeFrame: on Days: 0, 2, 30, 60 and 90
measure: the TRM of scar
timeFrame: on Days: 0, 2, 30, 60 and 90
Other outcomes:
measure: reproductive information
timeFrame: 2 years
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: