Cesarean Section ComplicationsNCT04766073
Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial
A study testing Niche prevention suture in people with Cesarean Section Complications and Uterine Bleeding, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
In the last decade we have been exposed to the complication of a caesarean section called a "niche". A niche is an anaerobic defect in the location of the cesarean section, which represents the discontinuity of the endometrium and myometrium. Read more about this study
- Who is it for?
- Ages 17 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Uterine Bleeding
- What is being tested?
- Niche prevention suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Jul 2021to Feb 2024
- 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 17 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women at first cesarean delivery
- Women who consent to the study
Who cannot join
- Women who are having a repeat caesarean section
- Refusal to participate in the study
- Urgent or emergent cesarean delivery
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Hadass Lemberg, PhD, +972 2 6777572, lhadas@hadassah.org.il
Hila Hochler, MD
About this study
In the last decade we have been exposed to the complication of a caesarean section called a "niche". A niche is an anaerobic defect in the location of the cesarean section, which represents the discontinuity of the endometrium and myometrium. A niche is usually diagnosed by ultrasound, and can also be diagnosed by hysterosalpingogram or hysteroscopy. In the presence of a niche women suffer more frequently from irregular bleeding, dysmenorrhea, chronic pelvic pain, and dyspareunia. We believe that a combination of tissue ischemia and thinning of the scar tissue that forms, causes a niche to form. Large randomized studies regarding the preferred surgical technique in cesarean section, including various methods of incision closure have found that there is no single method that is obviously superior. However, these studies did not examine niche formation as a complication of cesarean section.
In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation.
- Conditions
- Cesarean Section Complications, Uterine Bleeding
- Being tested
- Niche prevention suture
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niche prevention sutureProcedure or surgery
This group will have the uterus sutured in two layers using a new technique.
| Study group | Role | What they receive |
|---|---|---|
| New Closure Technique | Experimental | This group will have the uterus closed after delivery of the fetus during cesarean section with a new technique. Receives: Procedure: Niche prevention suture |
| Regular closure technique | No intervention | The usual method of closing the surgical incision is to suture the entire wall of the uterus with a stratafix suture without locking the suture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formation of a uterine niche
Presence of a uterine niche on ultrasound
Measured: At least 12 weeks after delivery.
Secondary outcomes (5)
Duration of surgery
Total duration of surgery
Measured: At surgery
Blood loss over 1000 mL
As assessed by the operating surgeon
Measured: At surgery
Postoperative infection
The number of patients who are diagnosed with postoperative infection including endometritis or wound infection.
Measured: Up to 6 weeks after intervention
Need for repeat laparotomy
The number of patients who undergo a repeat laparotomy after the initial cesarean delivery will be ascertained.
Measured: Up to 6 weeks after intervention
Formation of a n abscess/hematoma
The number of patients who are diagnosed with a pelvic abscess or hematoma from the time of the cesarean delivery until 6 weeks after the cesarean delivery.
Measured: Up to 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start22 Jul 2021
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hila Hochler, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766073
- Sponsor's protocol ID
- 8978006-HMO-CTIL
- Status last verified
- Sep 2023
- First submitted
- 17 Feb 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04766073
- Acronym / sponsor ID
- 8978006-HMO-CTIL
- Conditions
- Cesarean Section Complications, Uterine Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 23 Feb 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.
In the last decade we have been exposed to the complication of a caesarean section called a "niche". A niche is an anaerobic defect in the location of the cesarean section, which represents the discontinuity of the endometrium and myometrium. A niche is usually diagnosed by ultrasound, and can also be diagnosed by hysterosalpingogram or hysteroscopy. In the presence of a niche women suffer more frequently from irregular bleeding, dysmenorrhea, chronic pelvic pain, and dyspareunia. We believe that a combination of tissue ischemia and thinning of the scar tissue that forms, causes a niche to form. Large randomized studies regarding the preferred surgical technique in cesarean section, including various methods of incision closure have found that there is no single method that is obviously superior. However, these studies did not examine niche formation as a complication of cesarean section.
In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Closure Technique | Experimental | Procedure: Niche prevention sutureThis group will have the uterus closed after delivery of the fetus during cesarean section with a new technique. |
| Regular closure technique | No intervention | –The usual method of closing the surgical incision is to suture the entire wall of the uterus with a stratafix suture without locking the suture. |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Women at first cesarean delivery
- Women who consent to the study
Key exclusion criteria (3 listed)
- Women who are having a repeat caesarean section
- Refusal to participate in the study
- Urgent or emergent cesarean delivery
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 |
|---|---|---|
| Niche prevention sutureThis group will have the uterus sutured in two layers using a new technique. | Procedure or surgery | New Closure Technique |
Primary outcome
Formation of a uterine niche
Time frame: At least 12 weeks after delivery.
Presence of a uterine niche on ultrasound
5 secondary outcomes
Duration of surgery
Time frame: At surgery
Blood loss over 1000 mL
Time frame: At surgery
Postoperative infection
Time frame: Up to 6 weeks after intervention
Need for repeat laparotomy
Time frame: Up to 6 weeks after intervention
Formation of a n abscess/hematoma
Time frame: Up to 6 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Hila Hochler, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Niche prevention suture in people with Cesarean Section Complications and Uterine Bleeding, run by Hadassah Medical Organization at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 25 Sep 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 Israel. 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?
Contact Hadas Lemberg, PhD (+972 2 6777572, lhadas@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Formation of a uterine niche (time frame: At least 12 weeks after delivery.). 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 25 Sep 2023.