Cesarean Section; DehiscenceNCT05770115
A Randomized Clinical Study Based on Comparison Between Closure of Uterine Incision With Vicryl 2/0 Versus Vicryl 1 in Development of Uterine Niche.
A study testing Vicryl 1 and Vicryl 2/0 in people with Cesarean Section; Dehiscence, run by Cairo University at 1 site in Egypt.
Trial summary
The first group patients underwent double layer closure with split thickness with vicryl 2/0, in continuous, non- locked, 1 cm apart sutures, study group, and the second group, women underwent double layer closure with split thickness with vicryl 1, in continuous, non- locked, 1 cm apart sutures, control group. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section; Dehiscence
- What is being tested?
- Vicryl 1 and Vicryl 2/0
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 10 Feb 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton term pregnancy.
- Parity less than 5.
- Women who undergo 1st cesarean section whether in labor or not.
Who cannot join
- Women with a previous CS.
- Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection).
- Women with known causes of menstrual disorders (e.g. cervical dysplasia, communicating hydro-salpinx, uterine anomaly or endocrine disorders disturbing ovulation).
- Abnormally invasive placenta during the current pregnancy.
- Multiple gestation, polyhydramnios.
- Maternal Diabetes, anemia and connective tissue disorders.
- Women with Body mass index > 35.
- Women with valval varicosities.
Trial locations and contacts
1 site in 1 country.
About this study
The first group patients underwent double layer closure with split thickness with vicryl 2/0, in continuous, non- locked, 1 cm apart sutures, study group, and the second group, women underwent double layer closure with split thickness with vicryl 1, in continuous, non- locked, 1 cm apart sutures, control group. Then, all women in the study were followed up for development of niche within 1 to 6 weeks. The assessment after one week postpartum was with using trans-abdominal Ultrasound, then after two to six weeks postpartum with transvaginal Ultrasound
Read the detailed description
Caesarean section rates have increased worldwide over the past decades from 6.7 to 19.1%, with a current European CS rate of 25% of all births. CS is considered to be a safe procedure that can be life saving for both mother and child but the increasing trend draws more attention to adverse outcomes related to CSs. A relatively new long-term sequela is the niche in the uterine caesarean scar. A niche is defined as "an indentation at the site of the uterine caesarean scar with a depth of at least 2 mm on ultrasound" and is present in 56-84% of women after one or more CSs .
It is realized that almost all of the increase in cesarean section rate is due to the increase in repeat operations, and primary cesarean deliveries for dystocia and fetal distress. These can be attributed to obstetric factors as increased primary cesarean delivery rate, failed induction. Maternal factors as Increased proportion of women > age 35, increased nulliparous women, increased elective primary cesarean deliveries and factors relating to the physician as Malpractice litigation concerns .
The hypotheses can be divided into surgery-related factors and patient related factors. In their paper they focused on surgery-related factors since these could be easily modified and studied in future RCTs .
These surgical-related factors include low (cervical) location of the uterine incision during a CS, Incomplete closure of the uterine wall, due to single-layer, endometrial saving closure technique or use of locking sutures and Surgical activities that may induce adhesion formation (i.e., non-closure of peritoneum, inadequate hemostasis, applied sutures, use of adhesion barriers).
Without questions, the uterine niche presents a pathology that requires evaluation and intervention to mitigate its prevalence. The aim of this study is to compare between closures of uterine incision with Vicryl 2/0 versus Vicryl 1 in developing a uterine niche.
- Conditions
- Cesarean Section; Dehiscence
- Being tested
- Vicryl 1, Vicryl 2/0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicryl 1Procedure or surgery
Double layer closure with split thickness with vicryl 1, in continuous, non-locked, 1 cm apart sutures.
Vicryl 2/0Procedure or surgery
Double layer closure with split thickness with vicryl 2/0, in continuous, non-locked, 1 cm apart sutures.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | vicryl 2/0 Receives: Procedure: Vicryl 2/0 |
| Group B | Active comparator | vicryl 1 Receives: Procedure: Vicryl 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of uterine niche
using transvaginal ultrasound for detection of development of CS scar niche
Measured: 6 weeks
Secondary outcomes (4)
operative time
operative time in minutes is measured from the time of skin incision to time of skin closure
Measured: 1 hour
size of cs niche
size of cs niche is measured in millimeters using transvaginal ultrasound.
Measured: 6 weeks
operative blood loss
operative blood loss in milliliteres as indicated by the wieghing the towels before and after CS.
Measured: 2 hours
postoperative haemoglobin
measured in mg/dl as full blood count is done 24 hours postoperative.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Nov 2020
- Primary completion15 Dec 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section; DehiscenceStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassiony Dabian, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770115
- Sponsor's protocol ID
- MS-467-2020
- Status last verified
- Mar 2023
- First submitted
- 29 Jan 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.
PubMed 23996650Byrne M, Aly A. The Surgical Suture. Aesthet Surg J. 2019 Mar 14;39(Suppl_2):S67-S72. doi: 10.1093/asj/sjz036.
PubMed 3086975170. Monika & Gupta, Monika & Goraya, s.P.s & Kaur, Tanjeet & Matreja, Prithpal. (2017). Single Layer Versus Double Layer Closure of Uterus during Caesarean Section - A Prospective Study in Index and Subsequent Pregnancy. International Archives of BioMedical and Clinical Research. 1. 10.21276/iabcr.2017.3.1.14.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study Based on Comparison Between Closure of Uterine Incision With Vicryl 2/0 Versus Vicryl 1 in Development of Uterine Niche.
- ClinicalTrials.gov ID
- NCT05770115
- Acronym / sponsor ID
- MS-467-2020
- Conditions
- Cesarean Section; Dehiscence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 15 Mar 2023 (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 first group patients underwent double layer closure with split thickness with vicryl 2/0, in continuous, non- locked, 1 cm apart sutures, study group, and the second group, women underwent double layer closure with split thickness with vicryl 1, in continuous, non- locked, 1 cm apart sutures, control group. Then, all women in the study were followed up for development of niche within 1 to 6 weeks. The assessment after one week postpartum was with using trans-abdominal Ultrasound, then after two to six weeks postpartum with transvaginal Ultrasound
Detailed description
Caesarean section rates have increased worldwide over the past decades from 6.7 to 19.1%, with a current European CS rate of 25% of all births. CS is considered to be a safe procedure that can be life saving for both mother and child but the increasing trend draws more attention to adverse outcomes related to CSs. A relatively new long-term sequela is the niche in the uterine caesarean scar. A niche is defined as "an indentation at the site of the uterine caesarean scar with a depth of at least 2 mm on ultrasound" and is present in 56-84% of women after one or more CSs .
It is realized that almost all of the increase in cesarean section rate is due to the increase in repeat operations, and primary cesarean deliveries for dystocia and fetal distress. These can be attributed to obstetric factors as increased primary cesarean delivery rate, failed induction. Maternal factors as Increased proportion of women > age 35, increased nulliparous women, increased elective primary cesarean deliveries and factors relating to the physician as Malpractice litigation concerns .
The hypotheses can be divided into surgery-related factors and patient related factors. In their paper they focused on surgery-related factors since these could be easily modified and studied in future RCTs .
These surgical-related factors include low (cervical) location of the uterine incision during a CS, Incomplete closure of the uterine wall, due to single-layer, endometrial saving closure technique or use of locking sutures and Surgical activities that may induce adhesion formation (i.e., non-closure of peritoneum, inadequate hemostasis, applied sutures, use of adhesion barriers).
Without questions, the uterine niche presents a pathology that requires evaluation and intervention to mitigate its prevalence. The aim of this study is to compare between closures of uterine incision with Vicryl 2/0 versus Vicryl 1 in developing a uterine niche.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Vicryl 2/0vicryl 2/0 |
| Group B | Active comparator | Procedure: Vicryl 1vicryl 1 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton term pregnancy.
- Parity less than 5.
- Women who undergo 1st cesarean section whether in labor or not.
Key exclusion criteria (8 listed)
- Women with a previous CS.
- Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection).
- Women with known causes of menstrual disorders (e.g. cervical dysplasia, communicating hydro-salpinx, uterine anomaly or endocrine disorders disturbing ovulation).
- Abnormally invasive placenta during the current pregnancy.
- Multiple gestation, polyhydramnios.
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 |
|---|---|---|
| Vicryl 1Double layer closure with split thickness with vicryl 1, in continuous, non-locked, 1 cm apart sutures. | Procedure or surgery | Group B |
| Vicryl 2/0Double layer closure with split thickness with vicryl 2/0, in continuous, non-locked, 1 cm apart sutures. | Procedure or surgery | Group A |
Primary outcome
prevalence of uterine niche
Time frame: 6 weeks
using transvaginal ultrasound for detection of development of CS scar niche
4 secondary outcomes
operative time
Time frame: 1 hour
size of cs niche
Time frame: 6 weeks
operative blood loss
Time frame: 2 hours
postoperative haemoglobin
Time frame: 24 hours
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 15 Mar 2023.
- Background: PubMed 23996650Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.
- Background: PubMed 30869751Byrne M, Aly A. The Surgical Suture. Aesthet Surg J. 2019 Mar 14;39(Suppl_2):S67-S72. doi: 10.1093/asj/sjz036.
- Background70. Monika & Gupta, Monika & Goraya, s.P.s & Kaur, Tanjeet & Matreja, Prithpal. (2017). Single Layer Versus Double Layer Closure of Uterus during Caesarean Section - A Prospective Study in Index and Subsequent Pregnancy. International Archives of BioMedical and Clinical Research. 1. 10.21276/iabcr.2017.3.1.14.
- Individual participant dataSharing planned: No
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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.
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 Vicryl 1 and Vicryl 2/0 in people with Cesarean Section; Dehiscence, run by Cairo University at 1 site in Egypt.
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 8 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 15 Mar 2023. 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 Egypt. 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?
prevalence of uterine niche (time frame: 6 weeks). 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 NCT05770115, which also lists 3 linked publications.
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 15 Mar 2023.