Caesarean Scar DefectNCT03930134
Sparse Uterine Closure in Cesarean Section
A study testing sparse uterine suture and one layer uterine closure in people with Caesarean Scar Defect, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
The existence and the characteristics of a wedge- shaped defect in the uterine incision scar were demonstrated by radiologic, ultrasonographic, endoscopic and histologic methods by various authors. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caesarean Scar Defect
- What is being tested?
- sparse uterine suture and one layer uterine closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Feb 2019to 2 Jan 2020
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancy
- Cicatricial uterus with contraindication to vaginal delivery (uterus bi or multi-cicatricial, corporal uterine scar, intra-mural myomectomy, dystocic presentation)
- Fetal macrosomia with a weight greater than 4Kg
- Placenta previa
Who cannot join
- Patients who refuse to participate in the study
- prenatally diagnosed fetal pathology (intrauterine growth restriction, malformation, genetics disorders)
- adherent placenta, an adnexal mass or a myoma at the lower uterine segment
- Cesarean section in a context of medical or obstetrical emergency
- Caesarean section with a high risk of bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sparse Uterine Closure in Caesarean Section: Short and Mid Term Results
The existence and the characteristics of a wedge- shaped defect in the uterine incision scar were demonstrated by radiologic, ultrasonographic, endoscopic and histologic methods by various authors.
Cesarean scar defect is a deficient uterine scar or scar dehiscence following a cesarean section involving myometrial discontinuity at the site of a previous cesarean section scar. Cesarean scar defects may be associated with many clinical problems such as ectopicpregnancy at the cesarean section scar, rupture of the uterus during a subsequent pregnancy, dysmenorrhea and abnormal uterine bleeding during the non-pregnant state. These complications are likely to be associated with poor uterine scar healing following cesarean sections.
Read more
Methods concerning closure of the uterine incision need to be considered with regards to benefit and potential harm in order to offer the best available surgical care to women undergoing cesarean section.
Sur-gical suturing technique and mechanical tension affecting the surgical wound are the most important factors related to the incisional integrity.
For this reason, investigators designed this prospective clinical study to analyze the effects of two different uterine suturing techniques. their aim was to compare the sparse closure of the uterine incision to classical one layer closure regarding short , mid and long term results. In deed, they compared :
- duration of surgery and calculated blood loss during surgery as short term results - incidence of postoperative defective healing of the uterine incision , thickness of the ultrasound imaged uterine scar as mid-term results .
- Incomplete uterine rupture, morbidly placental adhesion during subsequent pregnancy of these patients as long-term results.
Read the detailed description
This is a secondary analyse of a first randomised trial comparing two caesarean techniques :
- Misgav Ladach with a one layer classic uterine closure.
- French ambulatory Caesarean section with a sparse uterine closure . The first trial is registred under the reference number : NCT03741907. 100 patients with an indication of an elective caesarean section were included in this trial : 50 had a one layer classic uterine closure and are enrolled in groupe 1 and 50 had a sparse uterine closure and are enrolled in groupe 2 .
- For the short term results investigators compared : duration of uterine sutures , visually estimated and calculated blood loss
- For the mid term results investigators are shuduling for all partient an hysterosonography 6 mounths after surgery and then will compare : incidence of postoperative defective healing of the uterine incision , thickness of the ultrasound imaged uterine scar as mid-term results .
- For the long term results investigators will interview patients 2 years after surgery in order to check for Incomplete uterine rupture, morbidly placental adhesion during subsequent pregnancy .
- Conditions
- Caesarean Scar Defect
- Being tested
- sparse uterine suture, one layer uterine closure
- Keywords
- caesarean, scar defect, sparse uterine suture, one layer uterine suture, blood loss, ultrasound
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sparse uterine sutureProcedure or surgery
The slowly absorbed Vicryl 1 suture with a large round needle is introduced intramyometrially right above the endometrium. The suture starts in one corner and proceeds along the lower then the upper edge returning back to the incision point. Subserous layer is closed upon using the same thread in order to cover the purse suture and to complete the haemostasis while increasing the wound thickness.
one layer uterine closureProcedure or surgery
one layer classical continious uterine closure using slowly absorbed Vicryl 1
| Study group | Role | What they receive |
|---|---|---|
| sparse uterine suture | Experimental | women who had a french ambulatory casarean section including a sparse uterine closure Receives: Procedure: sparse uterine suture |
| one layer uterine closure | Active comparator | women who had a misgav ladach caesarean section section, including a one layer classical uterine closure Receives: Procedure: one layer uterine closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
uterine scar quality
ultrasound visualization of a defect on the internal wall of the uterine scar (niche)
Measured: 6 mounth after surgery
Secondary outcomes (3)
uterine scar thickness
ultrasound Measured thickness of the scar in sagittal and coronal section.
Measured: 6 mounth after surgery
duration of surgery
time spent for uterine closure
Measured: during the caesarean section
calculated blood loss
post delivery hematocrit -predelivery hematocrit
Measured: before and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 Feb 2019
- Primary completion30 Dec 2019
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean Scar DefectStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaouther Dimassi, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930134
- Sponsor's protocol ID
- sparse uterine closure
- Status last verified
- Jan 2020
- First submitted
- 23 Apr 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sparse Uterine Closure in Caesarean Section: Short and Mid Term Results
- ClinicalTrials.gov ID
- NCT03930134
- Acronym / sponsor ID
- sparse uterine closure
- Conditions
- Caesarean Scar Defect
- Keywords
- caesarean, scar defect, sparse uterine suture, one layer uterine suture, blood loss, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 29 Apr 2019 (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.
The existence and the characteristics of a wedge- shaped defect in the uterine incision scar were demonstrated by radiologic, ultrasonographic, endoscopic and histologic methods by various authors.
Cesarean scar defect is a deficient uterine scar or scar dehiscence following a cesarean section involving myometrial discontinuity at the site of a previous cesarean section scar. Cesarean scar defects may be associated with many clinical problems such as ectopicpregnancy at the cesarean section scar, rupture of the uterus during a subsequent pregnancy, dysmenorrhea and abnormal uterine bleeding during the non-pregnant state. These complications are likely to be associated with poor uterine scar healing following cesarean sections.
Methods concerning closure of the uterine incision need to be considered with regards to benefit and potential harm in order to offer the best available surgical care to women undergoing cesarean section.
Sur-gical suturing technique and mechanical tension affecting the surgical wound are the most important factors related to the incisional integrity.
For this reason, investigators designed this prospective clinical study to analyze the effects of two different uterine suturing techniques. their aim was to compare the sparse closure of the uterine incision to classical one layer closure regarding short , mid and long term results. In deed, they compared :
- duration of surgery and calculated blood loss during surgery as short term results - incidence of postoperative defective healing of the uterine incision , thickness of the ultrasound imaged uterine scar as mid-term results .
- Incomplete uterine rupture, morbidly placental adhesion during subsequent pregnancy of these patients as long-term results.
Detailed description
This is a secondary analyse of a first randomised trial comparing two caesarean techniques :
- Misgav Ladach with a one layer classic uterine closure.
- French ambulatory Caesarean section with a sparse uterine closure . The first trial is registred under the reference number : NCT03741907. 100 patients with an indication of an elective caesarean section were included in this trial : 50 had a one layer classic uterine closure and are enrolled in groupe 1 and 50 had a sparse uterine closure and are enrolled in groupe 2 .
- For the short term results investigators compared : duration of uterine sutures , visually estimated and calculated blood loss
- For the mid term results investigators are shuduling for all partient an hysterosonography 6 mounths after surgery and then will compare : incidence of postoperative defective healing of the uterine incision , thickness of the ultrasound imaged uterine scar as mid-term results .
- For the long term results investigators will interview patients 2 years after surgery in order to check for Incomplete uterine rupture, morbidly placental adhesion during subsequent pregnancy .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sparse uterine suture | Experimental | Procedure: sparse uterine suturewomen who had a french ambulatory casarean section including a sparse uterine closure |
| one layer uterine closure | Active comparator | Procedure: one layer uterine closurewomen who had a misgav ladach caesarean section section, including a one layer classical uterine closure |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- singleton pregnancy
- Cicatricial uterus with contraindication to vaginal delivery (uterus bi or multi-cicatricial, corporal uterine scar, intra-mural myomectomy, dystocic presentation)
- Fetal macrosomia with a weight greater than 4Kg
- Placenta previa
Key exclusion criteria (5 listed)
- Patients who refuse to participate in the study
- prenatally diagnosed fetal pathology (intrauterine growth restriction, malformation, genetics disorders)
- adherent placenta, an adnexal mass or a myoma at the lower uterine segment
- Cesarean section in a context of medical or obstetrical emergency
- Caesarean section with a high risk of bleeding
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 |
|---|---|---|
| sparse uterine sutureThe slowly absorbed Vicryl 1 suture with a large round needle is introduced intramyometrially right above the endometrium. The suture starts in one corner and proceeds along the lower then the upper edge returning back to the incision point. Subserous layer is closed upon using the same thread in order to cover the purse suture and to complete the haemostasis while increasing the wound thickness. | Procedure or surgery | sparse uterine suture |
| one layer uterine closureone layer classical continious uterine closure using slowly absorbed Vicryl 1 | Procedure or surgery | one layer uterine closure |
Primary outcome
uterine scar quality
Time frame: 6 mounth after surgery
ultrasound visualization of a defect on the internal wall of the uterine scar (niche)
3 secondary outcomes
uterine scar thickness
Time frame: 6 mounth after surgery
duration of surgery
Time frame: during the caesarean section
calculated blood loss
Time frame: before and 24 hours after surgery
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 10 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Caesarean Scar Defect
Recruiting
Single- vs Double-Layer Cesarean Scar Repair and Myometrial Thickness
Caesarean Section, Cesarean Scar Closure
Not yet recruiting
Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect
Caesarean Scar Defect
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sparse uterine suture and one layer uterine closure in people with Caesarean Scar Defect, run by University Tunis El Manar at 1 site in Tunisia.
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 4 inclusion and 5 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 10 Jan 2020. 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 Tunisia. 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?
uterine scar quality (time frame: 6 mounth after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2020.