Cesarean Section Complications(PICS)NCT03826459
Preventing Isthmocele After Cesarean Section
A study testing Non-Locking Uterine Closure and Locked Uterine Closure in people with Cesarean Section Complications and Uterine Scar Diverticulum, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Cesarean section accounts for nearly 30% of births in Canada, and is the most commonly performed surgery by Obstetrician Gynecologists. Cesarean scar isthmocele, meaning a defect in the uterine wall at the site of a previous uterine incision, is a common complication of this surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Uterine Scar Diverticulum, Uterine Scar From Previous Cesarean Delivery
- What is being tested?
- Non-Locking Uterine Closure and Locked Uterine Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- 5 Mar 2019to 18 Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women undergoing their first cesarean section
Who cannot join
- previous uterine hysterotomy (caesarean section, myomectomy, etc.)
- known uterine anomalies
- active labour
- known bleeding disorder
- maternal connective tissue disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The PICS Trial: A Pilot Randomized Controlled Trial of Non-Locked vs. Locked Uterine Closure at Cesarean Section for Prevention of Uterine Isthmocele Formation
Cesarean section accounts for nearly 30% of births in Canada, and is the most commonly performed surgery by Obstetrician Gynecologists. Cesarean scar isthmocele, meaning a defect in the uterine wall at the site of a previous uterine incision, is a common complication of this surgery. While most are likely asymptomatic, isthmoceles can lead to major complications in pregnancy (uterine rupture, invasive placentation, cesarean scar ectopic pregnancy) and outside of pregnancy (abnormal uterine bleeding, infertility and pain). Studies have shown that the method used to suture the uterus at the time of a cesarean section may have an impact on the incidence of post-operative isthmocele formation. Our study is a randomized control trial of the impact of locked vs unlocked uterine closure at cesarean section on the incidence of isthmocele formation. Women undergoing cesarean section will be randomized to have either a locked or unlocked uterine closure. They will then return 6 months after their surgery for a transvaginal ultrasound to evaluate the presence or absence of an isthmocele.
This study is a pilot trial. The investigators hope to determine the feasibility of completing a large randomized control trial by recording: a) the number of patient who agree to participate in this study, b) the number of patients who receive the correct intervention and, c) the number of patients who return for their post operative ultrasound.
The investigators also plan to assess multiple secondary outcomes. First, the goal is to determine the isthmocele incidence within the study subjects of the pilot trial in order to perform a power calculation for a subsequent larger trial in this area. Another goal is to determine if the uterine closure techniques in this study lead to differences in surgical time, blood loss or the need for intra- or post-operative blood transfusion. Last, the study will collect data on the suture material most commonly used in this study to determine if this requires standardization in the subsequent larger trial.
Read the detailed description
Cesarean section accounts for nearly 30% of all deliveries in Canada, and is the most commonly performed surgery by Obstetrician Gynecologists (OBGYNs) in Canada. Therefore, it is important to understand the short and long-term complications of this procedure. Recently, emphasis has been placed on cesarean scar isthmocele as a long-term complication. An isthmocele is a defect at the cesarean section scar site with a depth of at least 1-2mm. Isthmoceles can lead to major obstetrical complications such as cesarean scar pregnancy, invasive placentation, and uterine rupture. More commonly, patients present with gynecologic symptoms: abnormal uterine bleeding, pain, and infertility. Up to 30-50% of patients with an isthmocele report symptoms when inquired. Isthmoceles have an incidence of 19-88% following cesarean section. This wide range is due to discrepancies in study technique, diagnostic criteria, and patient characteristics.
While medical and surgical treatment options are available for cesarean scar isthmocele, our focus should turn to prevention at the time of cesarean section. Evidence suggests double-layer (vs. single-layer) uterine closure decreases the formation of cesarean scar isthmocele and increases residual myometrial thickness (RMT). Additionally, uterine closure with a locked suturing technique may result in greater isthmocele depth and size, and a thinner RMT at the cesarean scar site. To our knowledge however, no study has determined the impact of a locked vs. unlocked double-layer closure technique on isthmocele prevention. Locked sutures, believed to be more hemostatic, may cause tissue necrosis and impair wound healing. Interestingly, evidence does not support reductions in operative blood loss with locked closure techniques. The hypothesis is that unlocked double-layer uterine closure can reduce isthmocele formation and thus improve longterm maternal outcomes without impacting operative blood loss or other short-term surgical outcomes.
- Conditions
- Cesarean Section Complications, Uterine Scar Diverticulum, Uterine Scar From Previous Cesarean Delivery
- Being tested
- Non-Locking Uterine Closure, Locked Uterine Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Locking Uterine ClosureProcedure or surgery
The first layer of the two-layer uterine closure will be sutured with a running \& non-locking technique. The second layer cannot be of a locking technique.
Locked Uterine ClosureProcedure or surgery
The first layer of the two-layer uterine closure will be sutured with a running \& locking technique. The second layer can be locking or non-locking.
| Study group | Role | What they receive |
|---|---|---|
| Locked Uterine Closure | Active comparator | Participants will undergo two-layer closure of the hysterotomy site at the time of cesarean section. The first layer will use a running \& locking technique. The second layer will be performed based on surgeon preference. Receives: Procedure: Locked Uterine Closure |
| Non-Locking Uterine Closure | Experimental | Participants will undergo two-layer closure of the hysterotomy site at the time of cesarean section. The first layer will use a running \& non-locking technique. The second layer will be performed based on surgeon preference, but cannot be of a locking technique. Receives: Procedure: Non-Locking Uterine Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Enrolled
Number of potential participants approached who actually enrolled in the trial
Measured: 6 months
Number of Participants that Cross-Over
Number of participants who cross-over to the other study arm (i.e. who receive the incorrect uterine closure technique)
Measured: 6 months
Number of Participants Lost to Follow Up
Number of participants enrolled in the trial who do not present for their follow up ultrasound at 6 months.
Measured: 6 months
Secondary outcomes (11)
Incidence of Isthmocele
The presence of an isthmocele (minimum 2 mm x 2 mm) identified on a transvaginal ultrasound 6 months after the cesarean section
Measured: 6 months
Estimated Blood Loss
Number of mL of blood lost at the time of cesarean section
Measured: Through surgery completion (estimated 1 hour)
Change in Hemoglobin
Change in Hgb from pre-operative measurement to Hgb measurement on post-operative day #1
Measured: 24 hours
Operative Time
Length of surgery (minutes)
Measured: Through surgery completion (estimated 1 hour)
Number of Blood Transfusions
Number of intraoperative and post-operative blood transfusions given to each participant
Measured: Throughout hospital stay (estimated 48 hours)
Additional Hemostatic Sutures
Number of additional hemostatic sutures placed in the uterus for each participant
Measured: Start to end of surgery
Suture Material
Type of suture material used for hysterotomy closure
Measured: 6 months
Use of Additional Oxytocin in Units
Number of units of additional oxytocin given to each participant as a uterotonic agent (beyond usual dose of intraoperative oxytocin)
Measured: Throughout hospital stay (estimated 48 hours)
Use of Ergotamine in mg
Number of mg Ergotamine used as a uterotonic agent, if required
Measured: Throughout hospital stay (estimated 48 hours)
Use of Hemabate in mg
Number of mg Ergotamine used as a uterotonic agent, if required
Measured: Throughout hospital stay (estimated 48 hours)
Use of Misoprostol in mcg
Number of mcg Misoprostol used as a uterotonic agent, if required
Measured: Throughout hospital stay (estimated 48 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start5 Mar 2019
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
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 Section ComplicationsStudies 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
- Model description
- Participants will be randomized to either locked or non-locked uterine closure at the time of cesarean section.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mara Sobel, Mount Sinai Hospital, Canada
- Investigators
- Mara Sobel, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826459
- Sponsor's protocol ID
- PICS
- Acronym
- (PICS)
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2019
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Warshafsky C, Kirubarajan A, Chaikof M, Stere A, Chudawala U, Li Q, Huszti E, Mohamed D, Abdalla MH, Hartman A, Sanders A, Murji A, Sobel M. Preventing Isthmocele After Cesarean Section (PICS): A Pilot Randomized Controlled Trial. J Obstet Gynaecol Can. 2022 Nov;44(11):1134-1135. doi: 10.1016/j.jogc.2022.08.003. Epub 2022 Aug 12. No abstract available.
PubMed 35970439
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PICS Trial: A Pilot Randomized Controlled Trial of Non-Locked vs. Locked Uterine Closure at Cesarean Section for Prevention of Uterine Isthmocele Formation
- ClinicalTrials.gov ID
- NCT03826459
- Acronym / sponsor ID
- (PICS) / PICS
- Conditions
- Cesarean Section Complications, Uterine Scar Diverticulum, Uterine Scar From Previous Cesarean Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 1 Feb 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 section accounts for nearly 30% of births in Canada, and is the most commonly performed surgery by Obstetrician Gynecologists. Cesarean scar isthmocele, meaning a defect in the uterine wall at the site of a previous uterine incision, is a common complication of this surgery. While most are likely asymptomatic, isthmoceles can lead to major complications in pregnancy (uterine rupture, invasive placentation, cesarean scar ectopic pregnancy) and outside of pregnancy (abnormal uterine bleeding, infertility and pain). Studies have shown that the method used to suture the uterus at the time of a cesarean section may have an impact on the incidence of post-operative isthmocele formation. Our study is a randomized control trial of the impact of locked vs unlocked uterine closure at cesarean section on the incidence of isthmocele formation. Women undergoing cesarean section will be randomized to have either a locked or unlocked uterine closure. They will then return 6 months after their surgery for a transvaginal ultrasound to evaluate the presence or absence of an isthmocele.
This study is a pilot trial. The investigators hope to determine the feasibility of completing a large randomized control trial by recording: a) the number of patient who agree to participate in this study, b) the number of patients who receive the correct intervention and, c) the number of patients who return for their post operative ultrasound.
The investigators also plan to assess multiple secondary outcomes. First, the goal is to determine the isthmocele incidence within the study subjects of the pilot trial in order to perform a power calculation for a subsequent larger trial in this area. Another goal is to determine if the uterine closure techniques in this study lead to differences in surgical time, blood loss or the need for intra- or post-operative blood transfusion. Last, the study will collect data on the suture material most commonly used in this study to determine if this requires standardization in the subsequent larger trial.
Detailed description
Cesarean section accounts for nearly 30% of all deliveries in Canada, and is the most commonly performed surgery by Obstetrician Gynecologists (OBGYNs) in Canada. Therefore, it is important to understand the short and long-term complications of this procedure. Recently, emphasis has been placed on cesarean scar isthmocele as a long-term complication. An isthmocele is a defect at the cesarean section scar site with a depth of at least 1-2mm. Isthmoceles can lead to major obstetrical complications such as cesarean scar pregnancy, invasive placentation, and uterine rupture. More commonly, patients present with gynecologic symptoms: abnormal uterine bleeding, pain, and infertility. Up to 30-50% of patients with an isthmocele report symptoms when inquired. Isthmoceles have an incidence of 19-88% following cesarean section. This wide range is due to discrepancies in study technique, diagnostic criteria, and patient characteristics.
While medical and surgical treatment options are available for cesarean scar isthmocele, our focus should turn to prevention at the time of cesarean section. Evidence suggests double-layer (vs. single-layer) uterine closure decreases the formation of cesarean scar isthmocele and increases residual myometrial thickness (RMT). Additionally, uterine closure with a locked suturing technique may result in greater isthmocele depth and size, and a thinner RMT at the cesarean scar site. To our knowledge however, no study has determined the impact of a locked vs. unlocked double-layer closure technique on isthmocele prevention. Locked sutures, believed to be more hemostatic, may cause tissue necrosis and impair wound healing. Interestingly, evidence does not support reductions in operative blood loss with locked closure techniques. The hypothesis is that unlocked double-layer uterine closure can reduce isthmocele formation and thus improve longterm maternal outcomes without impacting operative blood loss or other short-term surgical outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either locked or non-locked uterine closure at the time of cesarean section.
| Arm | Type | Receives |
|---|---|---|
| Locked Uterine Closure | Active comparator | Procedure: Locked Uterine ClosureParticipants will undergo two-layer closure of the hysterotomy site at the time of cesarean section. The first layer will use a running \& locking technique. The second layer will be performed based on surgeon preference. |
| Non-Locking Uterine Closure | Experimental | Procedure: Non-Locking Uterine ClosureParticipants will undergo two-layer closure of the hysterotomy site at the time of cesarean section. The first layer will use a running \& non-locking technique. The second layer will be performed based on surgeon preference, but cannot be of a locking technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing their first cesarean section
Key exclusion criteria (5 listed)
- previous uterine hysterotomy (caesarean section, myomectomy, etc.)
- known uterine anomalies
- active labour
- known bleeding disorder
- maternal connective tissue disorders
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 |
|---|---|---|
| Non-Locking Uterine ClosureThe first layer of the two-layer uterine closure will be sutured with a running \& non-locking technique. The second layer cannot be of a locking technique. | Procedure or surgery | Non-Locking Uterine Closure |
| Locked Uterine ClosureThe first layer of the two-layer uterine closure will be sutured with a running \& locking technique. The second layer can be locking or non-locking. | Procedure or surgery | Locked Uterine Closure |
Primary outcome
Number of Participants Enrolled
Time frame: 6 months
Number of potential participants approached who actually enrolled in the trial
Number of Participants that Cross-Over
Time frame: 6 months
Number of participants who cross-over to the other study arm (i.e. who receive the incorrect uterine closure technique)
Number of Participants Lost to Follow Up
Time frame: 6 months
Number of participants enrolled in the trial who do not present for their follow up ultrasound at 6 months.
11 secondary outcomes
Incidence of Isthmocele
Time frame: 6 months
Estimated Blood Loss
Time frame: Through surgery completion (estimated 1 hour)
Change in Hemoglobin
Time frame: 24 hours
Operative Time
Time frame: Through surgery completion (estimated 1 hour)
Number of Blood Transfusions
Time frame: Throughout hospital stay (estimated 48 hours)
Additional Hemostatic Sutures
Time frame: Start to end of surgery
Suture Material
Time frame: 6 months
Use of Additional Oxytocin in Units
Time frame: Throughout hospital stay (estimated 48 hours)
Use of Ergotamine in mg
Time frame: Throughout hospital stay (estimated 48 hours)
Use of Hemabate in mg
Time frame: Throughout hospital stay (estimated 48 hours)
Use of Misoprostol in mcg
Time frame: Throughout hospital stay (estimated 48 hours)
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 25 Jan 2022.
- Derived from this study: PubMed 35970439Warshafsky C, Kirubarajan A, Chaikof M, Stere A, Chudawala U, Li Q, Huszti E, Mohamed D, Abdalla MH, Hartman A, Sanders A, Murji A, Sobel M. Preventing Isthmocele After Cesarean Section (PICS): A Pilot Randomized Controlled Trial. J Obstet Gynaecol Can. 2022 Nov;44(11):1134-1135. doi: 10.1016/j.jogc.2022.08.003. Epub 2022 Aug 12. No abstract available.
- 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.
Mara Sobel, MD principal investigator
MOUNT SINAI 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 Non-Locking Uterine Closure and Locked Uterine Closure in people with Cesarean Section Complications and Uterine Scar Diverticulum, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 1 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: finished, as of the sponsor's last update on 25 Jan 2022. 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 Canada. 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?
Number of Participants Enrolled (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT03826459, 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 25 Jan 2022.