- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07523698
Vesico-uterin Thickness and Sliding Sign in Term Pregnancies (sliding sign)
Comparision of Ultrasonographic Vesicouterin Thickness Measurement and Sliding Sign in Term Pregnancies With and Without Cesarean Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
The study aimed to evaluate the bladder and uterus ultrasonographically and intraabdominal adhesions prior the cesarean section. Pregnant women aged 18-45 years with singleton, viable third-trimester (37 weeks of gestation or later) pregnancies with the history of at least one previous cesarean section were included in the study. The control group consisted of healthy pregnant women in the third trimester with similar demographic characteristics who underwent elective (planned) cesarean delivery and had no obstetric or medical comorbidities. Control group had no history of previous cesarean section. The indications in control group for cesarean section consisted cephalopelvic disproportion and rare other malpresentations.Exclusion criteria included uterine anomalies, intra-abdominal cysts or myomas, multiple pregnancies, a history of additional intra-abdominal surgery, a history of steroid use, collagen disorders, and placental adhesion or invasion anomalies. To ensure homogeneity between groups, patients with comparable body mass index values were preferentially selected.
The patients' obstetric history at the time of admission (gravida, parity, abortion), age, height, weight, gestational age, routine obstetric measurements (fetal position, placental location, amniotic fluid volume, etc.), personal and family history were all recorded. Birth weight and Apgar scores of the newborns were also recorded.
The cesarean scar incision line was visually examined and scored. The scar incision score recorded as inwardly displaced (deplaced), at skin level (flat), or raised (keloid-like).
Stretch marks that form on the abdomen during pregnancy were evaluated and noted according to the proportion they cover when the abdomen was divided into four sections. Stretch mark scores recorded as follows: none for absence of stretch marks, 1/4 for quarter, 1/2 for half and 3/4 for one-third of the abdomen.Intra-abdominal adhesions in patients undergoing cesarean section were classified according to the Nair adhesion scoring system, regardless of prior ultrasound assessment.
Accordingly, the classification recorded as follows: Grade 0: absence of adhesions, Grade 1: presence of a single band of adhesion between the visceral peritoneum and the abdominal surface, Grade 2: presence of two bands of adhesion between the visceral peritoneum and the abdominal surface, Grade 3: presence of three or more bands of adhesion between the visceral peritoneum and the abdominal surface, Grade 4: presence of multiple dense adhesions. The presence of the sliding sign was evaluated as described by Baron et al..The probe was placed just above the transverse skin scar and the patient was asked to take a deep breath or cough in order for the uterus to be observed sliding caudally under the parietal peritoneum and fascia transversalis. Presence of the sliding sign was described "positive" when sliding of the uterus against the abdominal wall was observed. When no movement of the uterus under the fascia, the sliding sign was considered "negative".
The relationship of the bladder to the uterus, whether it was below or above the symphysis pubis were noted. The tissue between the uterus and bladder (vesicouterin thickness) was examined and mesasured.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yuregir
-
Adana, Yuregir, Turkey (Türkiye), 01230
- University of Heath and Science Adana City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-45 years
- viable singleton third-trimester (37 weeks of gestation or later) pregnancies
- history of at least one previous cesarean section
Exclusion Criteria:
- uterine anomalies,
- intra-abdominal cysts or myomas,
- multiple pregnancies,
- history of additional intra-abdominal surgery,
- history of steroid use, collagen disorders,
- placental adhesion or invasion anomalies.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: intervention (study) group
repeated cesarean group
|
The probe was placed just above the transverse skin scar and the patient was asked to take a deep breath or cough in order for the uterus to be observed sliding caudally under the parietal peritoneum and fascia transversalis.
Presence of the sliding sign was described "positive" when sliding of the uterus against the abdominal wall was observed.
When no movement of the uterus under the fascia, the sliding sign was considered "negative".
Other Names:
|
|
Active Comparator: control group
primigravid patients
|
The probe was placed just above the transverse skin scar and the patient was asked to take a deep breath or cough in order for the uterus to be observed sliding caudally under the parietal peritoneum and fascia transversalis.
Presence of the sliding sign was described "positive" when sliding of the uterus against the abdominal wall was observed.
When no movement of the uterus under the fascia, the sliding sign was considered "negative".
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sliding sign
Time Frame: The study will end when a sufficient number of patients is reached.
|
The probe was placed just above the transverse skin scar and the patient was asked to take a deep breath or cough in order for the uterus to be observed sliding caudally under the parietal peritoneum and fascia transversalis.
Presence of the sliding sign was described "positive" when sliding of the uterus against the abdominal wall was observed.
When no movement of the uterus under the fascia, the sliding sign was considered "negative".
|
The study will end when a sufficient number of patients is reached.
|
|
Vesicouterin thickness
Time Frame: Approximately 6 months. The study will complete when required number of patients reached.
|
The tissue between the uterus and bladder (vesicouterin thickness) was examined and mesasured.
|
Approximately 6 months. The study will complete when required number of patients reached.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gülsüm Uysal, Department of Obstetrics and Gynecology, University of Health and Science Adana City Training and Research Hospital, Adana, Turkey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3015/12.2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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