Cesarean Scar NicheNICUMNCT02410395
NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique
A study testing Conventional and Modified in people with Cesarean Scar Niche, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this trial was to compare two different uterotomy surgical techniques on the occurrence of a uterine niche and the risk of a number of short- and long-term gynecological complications associated with the presence and size of the niche. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Scar Niche
- What is being tested?
- Conventional and Modified
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2015to Mar 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton pregnant
- Intended elective cesarean section
Who cannot join
- Cervical dilatation of more than 4 cm
- Previous cesarean section
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dep. Obstetrics and Gynecology, Regional Hospital of Randers
Randers, 8930
About this study
Official title: NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique (NICUM Study)
The aim of this trial was to compare two different uterotomy surgical techniques on the occurrence of a uterine niche and the risk of a number of short- and long-term gynecological complications associated with the presence and size of the niche.
- Conditions
- Cesarean Scar Niche
- Being tested
- Conventional, Modified
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConventionalProcedure or surgery
Two-layer technique with the first layer performed as an un-locked, continuous suture without inclusion of the endometrium and the second layer performed as an un-locked, continuous suture with the stitches placed superficially, horizontally along the first layer.
ModifiedProcedure or surgery
The modified mattress suture is performed as a single-suture, double-layer technique with limited inclusion of the myometrium and broad inclusion of the serosal surface and myometrium, interchangeably
| Study group | Role | What they receive |
|---|---|---|
| Conventional technique | Active comparator | Closure of the uterotomy with a conventional two-layer technique Receives: Procedure: Conventional |
| Modified technique | Experimental | Closure of the uterotomy with a modified two-layer technique Receives: Procedure: Modified |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a cesarean scar niche more than 2 mm deep.
Measured: 6 months
Secondary outcomes (5)
Residual myometrial thickness of the cesarean scar (RMT)
Measured: 6 months
Cesarean scar niche depth, width, length, myometrium adjacent to the scar
Measured: 6 months
Post-menstrual spotting
Measured: 15 months
Incidence of cesarean scar pregnancy or spontaneous abortions
Measured: 72 months
Adverse pregnancy outcomes in the following pregnancy
Composite of placenta previa, placenta accreta or percreta, uterine rupture or dehiscence
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study start1 May 2015
- Primary completion2 May 2018
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Scar NicheStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital
- Responsible party
- Sponsor
- Investigators
- Niels Uldbjerg, MD, DMSc, Study chair, Aarhus University HospitalLone Hvidman, MD, PhD, Study chair, Aarhus University HospitalAxel Forman, MD, DMSc, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410395
- Sponsor's protocol ID
- AUH060804
- Acronym
- NICUM
- Status last verified
- May 2018
- First submitted
- 1 Apr 2015
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique (NICUM Study)
- ClinicalTrials.gov ID
- NCT02410395
- Acronym / sponsor ID
- NICUM / AUH060804
- Conditions
- Cesarean Scar Niche
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Randers Regional Hospital
- Study start
- 1 May 2015 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- Mar 2023 (estimated)
- First posted
- 7 Apr 2015 (estimated)
- 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 aim of this trial was to compare two different uterotomy surgical techniques on the occurrence of a uterine niche and the risk of a number of short- and long-term gynecological complications associated with the presence and size of the niche.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional technique | Active comparator | Procedure: ConventionalClosure of the uterotomy with a conventional two-layer technique |
| Modified technique | Experimental | Procedure: ModifiedClosure of the uterotomy with a modified two-layer technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Singleton pregnant
- Intended elective cesarean section
Key exclusion criteria (2 listed)
- Cervical dilatation of more than 4 cm
- Previous 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 |
|---|---|---|
| ConventionalTwo-layer technique with the first layer performed as an un-locked, continuous suture without inclusion of the endometrium and the second layer performed as an un-locked, continuous suture with the stitches placed superficially, horizontally along the first layer. | Procedure or surgery | Conventional technique |
| ModifiedThe modified mattress suture is performed as a single-suture, double-layer technique with limited inclusion of the myometrium and broad inclusion of the serosal surface and myometrium, interchangeably | Procedure or surgery | Modified technique |
Primary outcome
Presence of a cesarean scar niche more than 2 mm deep.
Time frame: 6 months
5 secondary outcomes
Residual myometrial thickness of the cesarean scar (RMT)
Time frame: 6 months
Cesarean scar niche depth, width, length, myometrium adjacent to the scar
Time frame: 6 months
Post-menstrual spotting
Time frame: 15 months
Incidence of cesarean scar pregnancy or spontaneous abortions
Time frame: 72 months
Adverse pregnancy outcomes in the following pregnancy
Time frame: 72 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
Related trials for Cesarean Scar Niche
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruitingObservational study
Effect of Methotrexate on Blood Loss During Laparoscopic Management of CS Scar Pregnancy
Cesarean Scar Pregnancy
Recruiting
Impact of a Bladder Flap on Cesarean Scar Niche Development
Cesarean Scar Defect
Recruiting
Platelet Rich Plasma for Uterine Scar
Cesarean Section Complications, Uterine Bleeding
Recruiting
Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women
Isthmocele, Cesarean Scar Diverticula
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.
Niels Uldbjerg, MD, DMSc study chair
Aarhus University Hospital
Lone Hvidman, MD, PhD study chair
Aarhus University Hospital
Axel Forman, MD, DMSc study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional and Modified in people with Cesarean Scar Niche, run by University of Aarhus at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 15 May 2018. 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 Denmark. 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?
Results are not available in the source record.
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?
Presence of a cesarean scar niche more than 2 mm deep. (time frame: 6 months). 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 15 May 2018.