Pregnancy RelatedC123TNCT05750394
Cesarean 123 Trial: Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery
A study testing Uterine layers closed, Suture Type and Endometrium in people with Pregnancy Related, run by Brigham and Women's Hospital.
Trial summary
The goal of this clinical trial is to compare post-operative uterine scar thickness in people who have had the uterus closed during cesarean sections by one of three different methods. 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
- Pregnancy Related
- What is being tested?
- Uterine layers closed, Suture Type and Endometrium
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jul 2025
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years or older
- Singleton gestation
- Nonurgent primary or secondary cesarean delivery at greater than 35w6d
- Body Mass Index (BMI) <35 kg/m^2
Who cannot join
- More than 1 prior cesarean delivery
- Multiple gestation
- Known coagulation disorder or current use of anti-coagulants
- Mullerian anomalies
- Placenta previa
About this study
Official title: Cesarean 123 Trial: Prospective Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery
The goal of this clinical trial is to compare post-operative uterine scar thickness in people who have had the uterus closed during cesarean sections by one of three different methods. The main questions it aims to answer are:
- Residual myometrial thickness at the scar site assessed by MRI performed 4 months after the procedure
- Myometrial niche formation assessed by MRI performed 4 months after the procedure
- Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness
- Post-operative change in hemoglobin
- Time required for hysterotomy closure
- The number of extra sutures required to achieve surgeon-acceptable hemostasis
Read more
Participants undergoing scheduled cesarean sections will be randomized to one of three different uterine closure methods. The methods are:
- Single layer closure using the following technique: Closure of the myometrium and serosa with one barbed suture using a running unlocked technique. The endometrium should be excluded.
- Double layer closure using the following technique: Closure of the full thickness of the myometrium with one smooth suture using a running locked technique. The endometrium should be excluded. Followed by imbrication of the second layer with one smooth suture using a running unlocked technique.
- Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture using a running unlocked technique followed by closure of the remaining myometrium and serosa with one barbed suture using a running unlocked technique. Or, Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture on using a running unlocked technique followed by closure of the remaining myometrium with one barbed suture a running unlocked technique followed by closure of the serosa with one barbed suture using a running unlocked technique.
Four months after the surgery, participants will have a MRI of the pelvis to assess the scar on the uterus.
- Conditions
- Pregnancy Related
- Being tested
- Uterine layers closed, Suture Type, Endometrium
- Keywords
- Cesarean, Myometrium, scar thickness, niche
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine layers closedProcedure or surgery
Uterus closed with 1, 2 or 3 layers
Suture TypeDevice
Barbed or smooth
EndometriumProcedure or surgery
Included or excluded
| Study group | Role | What they receive |
|---|---|---|
| Single Layer Closure | Active comparator | Single layer closure using the following technique:
a. Closure of the myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique. The endometrium should be excluded. Receives: Procedure: Uterine layers closed; Device: Suture Type; Procedure: Endometrium |
| Double Layer Closure | Active comparator | Double layer closure using the following technique:
1. Closure of the full thickness of the myometrium with one (1) Monocryl suture on a CT needle using a running locked technique. The endometrium should be excluded.
2. Imbrication of the first layer with one (1) Monocryl suture on a CT needle using a running un-locked technique Receives: Procedure: Uterine layers closed; Device: Suture Type; Procedure: Endometrium |
| Triple Layer Closure | Active comparator | Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques:
1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique
2. Closure of the remaining myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique
or
1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique
2. Closure of the remaining myometrium with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique
3. Closure of the serosa with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique Receives: Procedure: Uterine layers closed; Device: Suture Type; Procedure: Endometrium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myometrial thickness
Residual myometrial thickness at the scar site assessed by MRI performed
Measured: 4 months
Secondary outcomes (5)
Niche
Myometrial niche formation assessed by MRI performed
Measured: 4 months
Scar ratio
Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness by MRI
Measured: 4 month
Blood loss
Post-operative change in hemoglobin
Measured: 1 day
Time for closure
Time required for hysterotomy closure
Measured: Immediate
Extra sutures
The number of extra sutures required to achieve surgeon-acceptable hemostasis
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: Lack of funding
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 Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Greenberg, MD, Brigham and Women's Hospital
- Investigators
- James A. Greenberg, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750394
- Sponsor's protocol ID
- 2023P000041
- Acronym
- C123T
- Status last verified
- Sep 2026
- First submitted
- 20 Feb 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Roberge S, Demers S, Girard M, Vikhareva O, Markey S, Chaillet N, Moore L, Paris G, Bujold E. Impact of uterine closure on residual myometrial thickness after cesarean: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):507.e1-507.e6. doi: 10.1016/j.ajog.2015.10.916. Epub 2015 Nov 11.
PubMed 26522861Alessandri 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cesarean 123 Trial: Prospective Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery
- ClinicalTrials.gov ID
- NCT05750394
- Acronym / sponsor ID
- C123T / 2023P000041
- Conditions
- Pregnancy Related
- Keywords
- Cesarean, Myometrium, scar thickness, niche
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 1 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 goal of this clinical trial is to compare post-operative uterine scar thickness in people who have had the uterus closed during cesarean sections by one of three different methods. The main questions it aims to answer are:
- Residual myometrial thickness at the scar site assessed by MRI performed 4 months after the procedure
- Myometrial niche formation assessed by MRI performed 4 months after the procedure
- Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness
- Post-operative change in hemoglobin
- Time required for hysterotomy closure
- The number of extra sutures required to achieve surgeon-acceptable hemostasis
Participants undergoing scheduled cesarean sections will be randomized to one of three different uterine closure methods. The methods are:
- Single layer closure using the following technique: Closure of the myometrium and serosa with one barbed suture using a running unlocked technique. The endometrium should be excluded.
- Double layer closure using the following technique: Closure of the full thickness of the myometrium with one smooth suture using a running locked technique. The endometrium should be excluded. Followed by imbrication of the second layer with one smooth suture using a running unlocked technique.
- Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture using a running unlocked technique followed by closure of the remaining myometrium and serosa with one barbed suture using a running unlocked technique. Or, Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture on using a running unlocked technique followed by closure of the remaining myometrium with one barbed suture a running unlocked technique followed by closure of the serosa with one barbed suture using a running unlocked technique.
Four months after the surgery, participants will have a MRI of the pelvis to assess the scar on the uterus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Layer Closure | Active comparator | Procedure: Uterine layers closed, Device: Suture Type, Procedure: EndometriumSingle layer closure using the following technique: a. Closure of the myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique. The endometrium should be excluded. |
| Double Layer Closure | Active comparator | Procedure: Uterine layers closed, Device: Suture Type, Procedure: EndometriumDouble layer closure using the following technique: 1. Closure of the full thickness of the myometrium with one (1) Monocryl suture on a CT needle using a running locked technique. The endometrium should be excluded. 2. Imbrication of the first layer with one (1) Monocryl suture on a CT needle using a running un-locked technique |
| Triple Layer Closure | Active comparator | Procedure: Uterine layers closed, Device: Suture Type, Procedure: EndometriumTriple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: 1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique 2. Closure of the remaining myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique or 1. Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique 2. Closure of the remaining myometrium with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique 3. Closure of the serosa with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 years or older
- Singleton gestation
- Nonurgent primary or secondary cesarean delivery at greater than 35w6d
- Body Mass Index (BMI) <35 kg/m^2
Key exclusion criteria (5 listed)
- More than 1 prior cesarean delivery
- Multiple gestation
- Known coagulation disorder or current use of anti-coagulants
- Mullerian anomalies
- Placenta previa
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 |
|---|---|---|
| Uterine layers closedUterus closed with 1, 2 or 3 layers | Procedure or surgery | Double Layer Closure, Single Layer Closure, Triple Layer Closure |
| Suture TypeBarbed or smooth | Device | Double Layer Closure, Single Layer Closure, Triple Layer Closure |
| EndometriumIncluded or excluded | Procedure or surgery | Double Layer Closure, Single Layer Closure, Triple Layer Closure |
Primary outcome
Myometrial thickness
Time frame: 4 months
Residual myometrial thickness at the scar site assessed by MRI performed
5 secondary outcomes
Niche
Time frame: 4 months
Scar ratio
Time frame: 4 month
Blood loss
Time frame: 1 day
Time for closure
Time frame: Immediate
Extra sutures
Time frame: Immediate
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Results publication: PubMed 26522861Roberge S, Demers S, Girard M, Vikhareva O, Markey S, Chaillet N, Moore L, Paris G, Bujold E. Impact of uterine closure on residual myometrial thickness after cesarean: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):507.e1-507.e6. doi: 10.1016/j.ajog.2015.10.916. Epub 2015 Nov 11.
- Results publication: 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: Yes
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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.
James A. Greenberg, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Uterine layers closed, Suture Type and Endometrium in people with Pregnancy Related, run by Brigham and Women's Hospital.
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: withdrawn, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Myometrial thickness (time frame: 4 months). 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 NCT05750394, 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 2 Oct 2026.