Cesarean Wound; DehiscenceBARB-LOWSEGMNCT05166174
Lower Uterine Segment Following a Cesarean Section With Barbed Suture
An observational study of Cesarean Wound; Dehiscence and Cesarean Section Complications, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 1 site in Italy.
Trial summary
This aim of this study is to investigate the LUS in the pregnancy following a previous cesarean section with the use of barbed or conventional smooth suture. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Wound; Dehiscence, Cesarean Section Complications
- What is being tested?
- Transvaginal ultrasound in the third trimester pregnancy
- Type of treatment
- Surgery or procedure
- How many people
- 93 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 1 Oct 2021
- Phase
- Observational
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women who underwent a previous elective cesarean section at term of pregnancy, during which the anteriore uterine wall was closed by using barbed or conventional smooth suture
Who may be able to join
- pregnant women
- being undergone a previous elective cesarean section at term of pregnancy (more than 37 weeks of gestation), in which barbed or conventional smooth suture was used for closing anterior uterine wall
Who cannot join
- having done more than one cesarean section
- having done a previous urgent cesarean section
- having done previous uterine surgical procedures with exception than one cesarean section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lower Uterine Segment at the Next Pregnancy Following a Cesarean Section With Barbed Suture: an Observational Prospective Comparative Study
This aim of this study is to investigate the LUS in the pregnancy following a previous cesarean section with the use of barbed or conventional smooth suture.
Read the detailed description
To better assess the risk of uterine rupture, some authors have proposed sonographic measurement of lower uterine segment (LUS) thickness near term, assuming that there is an inverse correlation between LUS thickness and the risk of uterine scar defect. Recently, barbed suture has been employed for closing uterine wall after cesarean section, demonstrating the reduction of closure time of the uterine incision and estimated blood loss. Until now, the impact of barbed suture in future pregnancies has not been investigated.
- Being tested
- Transvaginal ultrasound in the third trimester pregnancy
- Keywords
- barbed suture, uterine lower segment, cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasound in the third trimester pregnancyProcedure or surgery
Ultrasonographic transvaginal exam in patients at third trimester pregnancy (34-38 weeks of gestation)
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women who underwent previous cesarean section with barbed suture | This group includes pregnant women, who underwent a previous cesarean section. During the previous surgical procedure, the hysterotomy was closed by using barbed suture ("Fish-bone suture"). Receives: Procedure: Transvaginal ultrasound in the third trimester pregnancy | |
| Pregnant women who underwent previous cesarean section with conventional smooth suture | This group includes pregnant women, who underwent a previous cesarean section. During the previous surgical procedure, the hysterotomy was closed conventional smooth suture. Receives: Procedure: Transvaginal ultrasound in the third trimester pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic measure of lower uterine segment thickness
Measure of lower uterine thickness (mm) at transvaginal ultrasound
Measured: 34-38 weeks following study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Jan 2019
- Primary completion1 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cesarean Wound; DehiscenceStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Ferrero, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
- Investigators
- Simone Ferrero, Principal investigator, Piazza della Vittoria 14, Genoa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166174
- Sponsor's protocol ID
- BARB-LOWSEGM
- Acronym
- BARB-LOWSEGM
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jastrow N, Chaillet N, Roberge S, Morency AM, Lacasse Y, Bujold E. Sonographic lower uterine segment thickness and risk of uterine scar defect: a systematic review. J Obstet Gynaecol Can. 2010 Apr;32(4):321-327. doi: 10.1016/S1701-2163(16)34475-9.
PubMed 20500938Alessandri F, Evangelisti G, Centurioni MG, Gustavino C, Ferrero S, Barra F. Fishbone double-layer barbed suture in cesarean section: a help in preventing long-term obstetric sequelae? Arch Gynecol Obstet. 2021 Sep;304(3):573-576. doi: 10.1007/s00404-021-06121-8.
PubMed 34146146
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Uterine Segment at the Next Pregnancy Following a Cesarean Section With Barbed Suture: an Observational Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT05166174
- Acronym / sponsor ID
- BARB-LOWSEGM / BARB-LOWSEGM
- Keywords
- barbed suture, uterine lower segment, cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e OstetriciaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 21 Dec 2021 (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.
This aim of this study is to investigate the LUS in the pregnancy following a previous cesarean section with the use of barbed or conventional smooth suture.
Detailed description
To better assess the risk of uterine rupture, some authors have proposed sonographic measurement of lower uterine segment (LUS) thickness near term, assuming that there is an inverse correlation between LUS thickness and the risk of uterine scar defect. Recently, barbed suture has been employed for closing uterine wall after cesarean section, demonstrating the reduction of closure time of the uterine incision and estimated blood loss. Until now, the impact of barbed suture in future pregnancies has not been investigated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women who underwent previous cesarean section with barbed suture | – | Procedure: Transvaginal ultrasound in the third trimester pregnancyThis group includes pregnant women, who underwent a previous cesarean section. During the previous surgical procedure, the hysterotomy was closed by using barbed suture ("Fish-bone suture"). |
| Pregnant women who underwent previous cesarean section with conventional smooth suture | – | Procedure: Transvaginal ultrasound in the third trimester pregnancyThis group includes pregnant women, who underwent a previous cesarean section. During the previous surgical procedure, the hysterotomy was closed conventional smooth suture. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women who underwent a previous elective cesarean section at term of pregnancy, during which the anteriore uterine wall was closed by using barbed or conventional smooth suture
Key inclusion criteria (2 listed)
- pregnant women
- being undergone a previous elective cesarean section at term of pregnancy (more than 37 weeks of gestation), in which barbed or conventional smooth suture was used for closing anterior uterine wall
Key exclusion criteria (3 listed)
- having done more than one cesarean section
- having done a previous urgent cesarean section
- having done previous uterine surgical procedures with exception than one cesarean section
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 |
|---|---|---|
| Transvaginal ultrasound in the third trimester pregnancyUltrasonographic transvaginal exam in patients at third trimester pregnancy (34-38 weeks of gestation) | Procedure or surgery | Pregnant women who underwent previous cesarean section with barbed suture, Pregnant women who underwent previous cesarean section with conventional smooth suture |
Primary outcome
Ultrasonographic measure of lower uterine segment thickness
Time frame: 34-38 weeks following study enrollment
Measure of lower uterine thickness (mm) at transvaginal ultrasound
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 21 Dec 2021.
- Background: PubMed 20500938Jastrow N, Chaillet N, Roberge S, Morency AM, Lacasse Y, Bujold E. Sonographic lower uterine segment thickness and risk of uterine scar defect: a systematic review. J Obstet Gynaecol Can. 2010 Apr;32(4):321-327. doi: 10.1016/S1701-2163(16)34475-9.
- Background: PubMed 34146146Alessandri F, Evangelisti G, Centurioni MG, Gustavino C, Ferrero S, Barra F. Fishbone double-layer barbed suture in cesarean section: a help in preventing long-term obstetric sequelae? Arch Gynecol Obstet. 2021 Sep;304(3):573-576. doi: 10.1007/s00404-021-06121-8.
- Individual participant dataSharing planned: Undecided
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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.
Simone Ferrero principal investigator
Piazza della Vittoria 14, Genoa, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Wound; Dehiscence and Cesarean Section Complications, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia 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 2 inclusion and 3 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 21 Dec 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?
Ultrasonographic measure of lower uterine segment thickness (time frame: 34-38 weeks following study enrollment). 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 NCT05166174, which also lists 2 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 21 Dec 2021.