Uterine ScarNCT03676907
Assessment of Single and Double Layer Suturation of Lower Segment Uterine Incision by USG After C/S
A study testing double layer suturation technique in people with Uterine Scar, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
After 6 months of cesarean delivery, the investigators will compare uterine incision scar defects of single and double layer suturation of uterine incision by transvaginal ultrasonography. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Scar
- What is being tested?
- double layer suturation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2018to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who are agreeing to participate in the study
- Planned or elective caesarean section
- The term singular pregnancies between 37 weeks 0/7 days - 41weeks 6/7 days of gestation that will be delivered on cesarean section without emergency conditions will be included in the study.
Who cannot join
- Not accepting to participate in the work
- Emergency cesarean
- Multiple pregnancy
- Diabetic patients
- Past uterine surgery
- Uterine malformation
Show all 9Show fewer
- The infectious process (local, uterine or systemic)
- If surgeon needs additional two more hemostatic suturation during cesarean section.
- Women with connective tissue disease will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Single and Double Layer Suturation of Lower Segment Uterine Incision by Ultrasonography After Cesarean Section
After 6 months of cesarean delivery, the investigators will compare uterine incision scar defects of single and double layer suturation of uterine incision by transvaginal ultrasonography.
Read the detailed description
In our clinic, cesarean operation is performed with blunt and sharp dissections in the abdomen followed by transverse incision of the lower segment to the uterus. After uterotomy, the incision will be closed with single or double layer suture. The single layer suture technique will be performed with suturing by taking approximately 1 cm of tissue from the upper and lower segments where the mucosa and muscular layer are stitched together and locking them continuously at intervals of about 1 cm. On the first layer of the double layer suture technique, about 0.5 cm of tissue is taken from the upper and lower segments and the mucosa is closed by locking about 1 cm intervals. On the second layer, about 1 cm of tissue is taken from lower and upper segments of the muscle layer and both sides will be sutured with continue non-locking suture technique. The uterotomy incision will be closed with multifilament, synthetic, braided, suture that absorbable in about 60-90 days. In both groups prophylactic intramuscular 1 gr Cefazolin and 20 intravenous units of oxytocin will be administered intravenously.
Randomization will be done according to the patient's ID numbers. Patients who have a single digit of the end of ID number will be closed with continuous locking with suture, and patients who have a single digit of the end of ID number will be closed with double suture. The suture technique used and the number of additional hemostatic sutures will be obtained from the operation note. In addition, demographic characteristics of the patients, duration of operation, hemoglobin changes within 24 hours post-operatively, infant birth weight, hospitalization time, estimated blood loss during surgery will be examined in the study. The estimated blood loss will be recorded from the level of the initial aspirator bag after the surgery.
Enrolled patients will be called for control 6 months after surgery. It will be evaluated by a single obstetrician in a supine position under standard conditions, with empty bladder, with transvaginal ultrasonographic device. Measurements will be made when the endometrium, lower uterine segment and cervix are visible in the sagittal section of the uterus during transvaginal ultrasonography. Scar defect will define as a hypoechoic wedge-shaped image that causes discontinuity in the structure of the endometrium which extending downward from the anterior line to the serosa. The width and depth of the sagittal plane of the defect and the axial length of the axial plane will be measured. Ultimately, these measurements will be taken volumetrically.
- Conditions
- Uterine Scar
- Being tested
- double layer suturation technique
- Keywords
- cesarean scar defect, single suturation technique, double suturation technique, myometrial thickness, uterine scar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double layer suturation techniqueProcedure or surgery
in our clinic uterine incision is sutured by single layer suturation technique routinely. in this arm, we will use double layer suturation technique which is also accepted as valid suturation technique in obstetrics and gynecology textbooks
| Study group | Role | What they receive |
|---|---|---|
| single layer suturation technique | No intervention | in this arm we use single layer suturation technique to suture uterine incision |
| double layer suturation technique | Experimental | in this arm we use double layer suturation technique to suture uterine incision Receives: Procedure: double layer suturation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing defective volume of myometrium at the location of cesarean section scar in double layer suturation technique and single layer suturation technique
The volume measurement will be obtained ultrasonographically as a result of the width and depth measured on the sagittal plane of the defect as described by the formula of π x 4/3 multiplied by the length which will be imaged on the axial section of the uterus. The length of myometrial tissue that extends perpendicularly from the lower end of the scar defect to the serosa, ie the distance between the inner and outer edges of the cesarean scar, will be assessed and measured as the residual myometrial thickness.
Measured: Over 6 months period after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start15 Mar 2018
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine ScarStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erhan Demirdag, Gazi University
- Investigators
- Erhan DEMİRDAĞ, MD. Academic, Study director, Ankara Gazi Üniversitesi Tıp Fakültesi HastanesiAnıl Doğukan Tutal, MD, Principal investigator, Ankara Gazi Üniversitesi Tıp Fakültesi HastanesiRecep Onur Karabacak, MD. Academic, Study chair, Ankara Gazi Üniversitesi Tıp Fakültesi Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676907
- Sponsor's protocol ID
- 237
- Status last verified
- Feb 2024
- First submitted
- 11 Sep 2018
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Raine-Fenning N, Jayaprakasan K, Clewes J, Joergner I, Bonaki SD, Chamberlain S, Devlin L, Priddle H, Johnson I. SonoAVC: a novel method of automatic volume calculation. Ultrasound Obstet Gynecol. 2008 Jun;31(6):691-6. doi: 10.1002/uog.5359.
PubMed 18484679
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Single and Double Layer Suturation of Lower Segment Uterine Incision by Ultrasonography After Cesarean Section
- ClinicalTrials.gov ID
- NCT03676907
- Acronym / sponsor ID
- 237
- Conditions
- Uterine Scar
- Keywords
- cesarean scar defect, single suturation technique, double suturation technique, myometrial thickness, uterine scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After 6 months of cesarean delivery, the investigators will compare uterine incision scar defects of single and double layer suturation of uterine incision by transvaginal ultrasonography.
Detailed description
In our clinic, cesarean operation is performed with blunt and sharp dissections in the abdomen followed by transverse incision of the lower segment to the uterus. After uterotomy, the incision will be closed with single or double layer suture. The single layer suture technique will be performed with suturing by taking approximately 1 cm of tissue from the upper and lower segments where the mucosa and muscular layer are stitched together and locking them continuously at intervals of about 1 cm. On the first layer of the double layer suture technique, about 0.5 cm of tissue is taken from the upper and lower segments and the mucosa is closed by locking about 1 cm intervals. On the second layer, about 1 cm of tissue is taken from lower and upper segments of the muscle layer and both sides will be sutured with continue non-locking suture technique. The uterotomy incision will be closed with multifilament, synthetic, braided, suture that absorbable in about 60-90 days. In both groups prophylactic intramuscular 1 gr Cefazolin and 20 intravenous units of oxytocin will be administered intravenously.
Randomization will be done according to the patient's ID numbers. Patients who have a single digit of the end of ID number will be closed with continuous locking with suture, and patients who have a single digit of the end of ID number will be closed with double suture. The suture technique used and the number of additional hemostatic sutures will be obtained from the operation note. In addition, demographic characteristics of the patients, duration of operation, hemoglobin changes within 24 hours post-operatively, infant birth weight, hospitalization time, estimated blood loss during surgery will be examined in the study. The estimated blood loss will be recorded from the level of the initial aspirator bag after the surgery.
Enrolled patients will be called for control 6 months after surgery. It will be evaluated by a single obstetrician in a supine position under standard conditions, with empty bladder, with transvaginal ultrasonographic device. Measurements will be made when the endometrium, lower uterine segment and cervix are visible in the sagittal section of the uterus during transvaginal ultrasonography. Scar defect will define as a hypoechoic wedge-shaped image that causes discontinuity in the structure of the endometrium which extending downward from the anterior line to the serosa. The width and depth of the sagittal plane of the defect and the axial length of the axial plane will be measured. Ultimately, these measurements will be taken volumetrically.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single layer suturation technique | No intervention | –in this arm we use single layer suturation technique to suture uterine incision |
| double layer suturation technique | Experimental | Procedure: double layer suturation techniquein this arm we use double layer suturation technique to suture uterine incision |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Those who are agreeing to participate in the study
- Planned or elective caesarean section
- The term singular pregnancies between 37 weeks 0/7 days - 41weeks 6/7 days of gestation that will be delivered on cesarean section without emergency conditions will be included in the study.
Key exclusion criteria (9 listed)
- Not accepting to participate in the work
- Emergency cesarean
- Multiple pregnancy
- Diabetic patients
- Past uterine surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| double layer suturation techniquein our clinic uterine incision is sutured by single layer suturation technique routinely. in this arm, we will use double layer suturation technique which is also accepted as valid suturation technique in obstetrics and gynecology textbooks | Procedure or surgery | double layer suturation technique |
Primary outcome
Comparing defective volume of myometrium at the location of cesarean section scar in double layer suturation technique and single layer suturation technique
Time frame: Over 6 months period after cesarean section
The volume measurement will be obtained ultrasonographically as a result of the width and depth measured on the sagittal plane of the defect as described by the formula of π x 4/3 multiplied by the length which will be imaged on the axial section of the uterus. The length of myometrial tissue that extends perpendicularly from the lower end of the scar defect to the serosa, ie the distance between the inner and outer edges of the cesarean scar, will be assessed and measured as the residual myometrial thickness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 18484679Raine-Fenning N, Jayaprakasan K, Clewes J, Joergner I, Bonaki SD, Chamberlain S, Devlin L, Priddle H, Johnson I. SonoAVC: a novel method of automatic volume calculation. Ultrasound Obstet Gynecol. 2008 Jun;31(6):691-6. doi: 10.1002/uog.5359.
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Cesarean Section Complications, Uterine Bleeding
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Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women
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Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical Studies Balancing Scar - Free and Anti - Dissemination
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erhan DEMİRDAĞ, MD. Academic study director
Ankara Gazi Üniversitesi Tıp Fakültesi Hastanesi
Anıl Doğukan Tutal, MD principal investigator
Ankara Gazi Üniversitesi Tıp Fakültesi Hastanesi
Recep Onur Karabacak, MD. Academic study chair
Ankara Gazi Üniversitesi Tıp Fakültesi Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing double layer suturation technique in people with Uterine Scar, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing defective volume of myometrium at the location of cesarean section scar in double layer suturation technique and single layer suturation technique (time frame: Over 6 months period after cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03676907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.