Cesarean Scar DefectNCT04073264
Isthmocele After Two Different Sutures in Cesarean Section
A study testing monofilament in people with Cesarean Scar Defect, run by Federico II University at 1 site in Italy.
Trial summary
Cesarean delivery (CD) rates are rising globally. about 30% of women delivered by CD in 2015 only in the USA. This increasing CD rate has stimulated an interest in the potential short- and long-term morbidity of CD scars. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Scar Defect
- What is being tested?
- monofilament
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 25 Jul 2021
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with singleton gestations
- Between ≥37 and ≤42 gestational age
- >18 <45 years
- Undergoing primary or secondary elective or urgent cesarean delivery
Who cannot join
- Multiple gestations
- Preterm cesarean
- 2 or more prior cesarean deliveries
- Uterine malformations
- Prior myomectomy
- Placenta accreta/previa
Trial locations and contacts
1 site in 1 country.
About this study
Cesarean delivery (CD) rates are rising globally. about 30% of women delivered by CD in 2015 only in the USA. This increasing CD rate has stimulated an interest in the potential short- and long-term morbidity of CD scars. In more than 50% of women with history of CD, a uterine scar defect, also called a "isthmocele," defined as a disruption of the myometrium in the CD uterine scar, can be observed when examined by gel instillation sonohysterography 6-12 months after the CD. Uterine scar defects detected on ultrasound have been associated with prolonged menstrual bleeding and postmenstrual spotting, as well as with an increased risk of several obstetrical complications in subsequent pregnancies, including uterine dehiscence and/or rupture, scar pregnancy and placenta previa and accreta. Another screening method associated with uterine scar rupture in women with prior CD is ultrasonographic measurement of the thickness of the lower uterine segment, as pioneered by Rozenberg et al. in 1996. A meta-analysis by Kok et al. supports the use of the residual myometrial thickness (RMT) for predicting uterine rupture during vaginal birth after cesarean. Uterine scar defects have been associated with lower RMT.
A growing body of evidence suggests that the surgical technique for uterine closure influences uterine scar healing and the RMT, but there is still no consensus about optimal uterine closure and type of suture. It is imperative to have evidence-based guidelines for each surgical step before recommending one technique over another.
The aim of our trial is to evaluate the incidence of cesarean scar defect according to type of suture at the time of cesarean
- Conditions
- Cesarean Scar Defect
- Being tested
- monofilament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monofilamentProcedure or surgery
In the intervention group,monofilament absorbable suture,will be used.
| Study group | Role | What they receive |
|---|---|---|
| monofilament | Experimental | monofilament absorbable suture Receives: Procedure: monofilament |
| polifilament | Active comparator | synthetic absorbable braided (polifilament) suture Receives: Procedure: monofilament |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of cesarean scar defects at ultrasound 6-months follow-up
Measured: 6-months follow-up after cesarean
Secondary outcomes (3)
incidence of scar defects at hysteroscopy at 6 months follow-up
Measured: 6-months follow-up after cesarean
Symptoms of cesarean scar defect
including pain, Abnormal bleeding, Vaginal discharge, Painful periods
Measured: 6-months follow-up after cesarean
RMT
residual myometrial thickness at ultrasound
Measured: 6-months follow-up after cesarean
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start1 Sep 2019
- Primary completion20 Jul 2021
- Study completion25 Jul 2021
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 Cesarean 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
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Saccone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073264
- Sponsor's protocol ID
- 129/19
- Status last verified
- Aug 2021
- First submitted
- 26 Aug 2019
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saccone G, De Angelis MC, Zizolfi B, Gragnano E, Musone M, Zullo F, Bifulco G, Di Spiezio Sardo A. Monofilament vs multifilament suture for uterine closure at the time of cesarean delivery: a randomized clinical trial. Am J Obstet Gynecol MFM. 2022 May;4(3):100592. doi: 10.1016/j.ajogmf.2022.100592. Epub 2022 Feb 4.
PubMed 35131497
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isthmocele After Two Different Sutures in Cesarean Section
- ClinicalTrials.gov ID
- NCT04073264
- Acronym / sponsor ID
- 129/19
- Conditions
- Cesarean Scar Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 25 Jul 2021 (actual)
- First posted
- 29 Aug 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.
Cesarean delivery (CD) rates are rising globally. about 30% of women delivered by CD in 2015 only in the USA. This increasing CD rate has stimulated an interest in the potential short- and long-term morbidity of CD scars. In more than 50% of women with history of CD, a uterine scar defect, also called a "isthmocele," defined as a disruption of the myometrium in the CD uterine scar, can be observed when examined by gel instillation sonohysterography 6-12 months after the CD. Uterine scar defects detected on ultrasound have been associated with prolonged menstrual bleeding and postmenstrual spotting, as well as with an increased risk of several obstetrical complications in subsequent pregnancies, including uterine dehiscence and/or rupture, scar pregnancy and placenta previa and accreta. Another screening method associated with uterine scar rupture in women with prior CD is ultrasonographic measurement of the thickness of the lower uterine segment, as pioneered by Rozenberg et al. in 1996. A meta-analysis by Kok et al. supports the use of the residual myometrial thickness (RMT) for predicting uterine rupture during vaginal birth after cesarean. Uterine scar defects have been associated with lower RMT.
A growing body of evidence suggests that the surgical technique for uterine closure influences uterine scar healing and the RMT, but there is still no consensus about optimal uterine closure and type of suture. It is imperative to have evidence-based guidelines for each surgical step before recommending one technique over another.
The aim of our trial is to evaluate the incidence of cesarean scar defect according to type of suture at the time of cesarean
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monofilament | Experimental | Procedure: monofilamentmonofilament absorbable suture |
| polifilament | Active comparator | Procedure: monofilamentsynthetic absorbable braided (polifilament) suture |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women with singleton gestations
- Between ≥37 and ≤42 gestational age
- >18 <45 years
- Undergoing primary or secondary elective or urgent cesarean delivery
Key exclusion criteria (6 listed)
- Multiple gestations
- Preterm cesarean
- 2 or more prior cesarean deliveries
- Uterine malformations
- Prior myomectomy
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 |
|---|---|---|
| monofilamentIn the intervention group,monofilament absorbable suture,will be used. | Procedure or surgery | monofilament, polifilament |
Primary outcome
incidence of cesarean scar defects at ultrasound 6-months follow-up
Time frame: 6-months follow-up after cesarean
3 secondary outcomes
incidence of scar defects at hysteroscopy at 6 months follow-up
Time frame: 6-months follow-up after cesarean
Symptoms of cesarean scar defect
Time frame: 6-months follow-up after cesarean
RMT
Time frame: 6-months follow-up after cesarean
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 24 Aug 2021.
- Derived from this study: PubMed 35131497Saccone G, De Angelis MC, Zizolfi B, Gragnano E, Musone M, Zullo F, Bifulco G, Di Spiezio Sardo A. Monofilament vs multifilament suture for uterine closure at the time of cesarean delivery: a randomized clinical trial. Am J Obstet Gynecol MFM. 2022 May;4(3):100592. doi: 10.1016/j.ajogmf.2022.100592. Epub 2022 Feb 4.
- 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 monofilament in people with Cesarean Scar Defect, run by Federico II University at 1 site in Italy.
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 6 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 24 Aug 2021. 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 Italy. 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?
incidence of cesarean scar defects at ultrasound 6-months follow-up (time frame: 6-months follow-up after cesarean). 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 NCT04073264, 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 24 Aug 2021.