Scar; Previous Cesarean SectionOPSTARNCT02703519
Optimization of the Healing Process of the Uterine Scar Tissue After Re-cesarean Section
A study testing resection of uterine scar tissue in people with Scar; Previous Cesarean Section and Complications; Cesarean Section, Wound, Dehiscence, run by Martin-Luther-Universität Halle-Wittenberg at 2 sites in Germany.
Trial summary
This prospective, controlled, clinical, intervention study measures the number of uterine Cesarean section scars and median myometrial thickness of women who underwent two Cesarean sections six to nine months after their last Cesarean section using transvaginal ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Scar; Previous Cesarean Section, Complications; Cesarean Section, Wound, Dehiscence
- What is being tested?
- resection of uterine scar tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2014to Aug 2016
- 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
- 18 years or older
- primary or secondary indication for cesarean section 6 to 9 months prior to the examination date
Who cannot join
- <18 years old
- current pregnancy
- congenital deformity of the uterus
- former surgery of the uterine myometrium
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt
Maternity Clinic, Magdeburg University Hospital
Magdeburg, Saxony-Anhalt
About this study
Official title: Optimierung Der Uterotomie-Wundheilung Nach Re-Sectio Caesarea
This prospective, controlled, clinical, intervention study measures the number of uterine Cesarean section scars and median myometrial thickness of women who underwent two Cesarean sections six to nine months after their last Cesarean section using transvaginal ultrasound.
It is the purpose of the study to assess if a resection of the uterine scar from a previous Cesarean section during a second Cesarean section could lead to a decrease in risk for subsequent pregnancies.
Read the detailed description
The average number of Cesarean sections in Germany has doubled from 1991 to 2011, making up 32,1% of all deliveries in 2011.
Several studies describe instances in which pregnancies following a previous Cesarean section were accompanied by complications such as life-threatening bleeding, placenta previa, placenta accreta, increta or percreta and dehiscence or uterine rupture.
The risk of those complications increases further with the uterine scar tissue of a second Cesarean section.
Today it is already common practice to resect uterine scars if the scar of a previous Cesarean section becomes symptomatic, or when a non-symptomatic uterine rupture or serious dehiscence are discovered during a Cesarean delivery.
In this study all participants of the interventional group are examined via intraoperative ultrasound to identify the first uterine Cesarean section scar and resect it completely.
Six to nine months after the resection participants will return for a one time follow-up. At this time, the investigators will measure the number of uterine scars and median myometrial thickness using transvaginal ultrasound. The results will be compared with those of two control groups, consisting of women who underwent either one or two Cesarean sections without the intervention.
The aim of the present study is to asses if the number of uterine scars and median myometrial thickness can be improved by the resection of the first uterine scar during a subsequent Cesarean section.
This will allow the investigators to draw conclusions regarding the benefit of routine resections of uterine Cesarean section scars, and whether this practice could lead to a decreased risk for women undergoing two or more Cesarean sections.
- Being tested
- resection of uterine scar tissue
- Keywords
- cesarean section, repeat, uterine scar tissue, transvaginal ultrasound, uterine rupture, placenta accreta, placenta percreta, placenta increta
- Medical subject headings
- Cicatrix, Wounds and Injuries, Uterine Rupture, Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resection of uterine scar tissueProcedure or surgery
resection of uterine scar tissue of a previous cesarean section during a second cesarean section
| Study group | Role | What they receive |
|---|---|---|
| 1 cesarean section | No intervention | control group |
| 2 cesarean sections | No intervention | control group |
| resection of uterine scar tissue | Experimental | 2 cesarean sections with resection of uterine scar tissue from first cesarean section Receives: Procedure: resection of uterine scar tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of uterine Cesarean section scars using transvaginal ultrasound
Measured: 6-9 months
Secondary outcomes (1)
median myometrial thickness of lower uterine segment using transvaginal ultrasound
Measured: 6-9months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startNov 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar; Previous Cesarean SectionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Otto-von-Guericke University Magdeburg
- Responsible party
- Principal investigator, Gregor Seliger, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Gregor Seliger, Dr. med., Principal investigator, Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-WittenbergMichael Tchirikov, Prof., Study chair, Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-WittenbergSerben-Dan Costa, Prof., Principal investigator, Maternity Clinic, Magdeburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703519
- Sponsor's protocol ID
- OPSTAR
- Acronym
- OPSTAR
- Status last verified
- Sep 2016
- First submitted
- 6 Mar 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimierung Der Uterotomie-Wundheilung Nach Re-Sectio Caesarea
- ClinicalTrials.gov ID
- NCT02703519
- Acronym / sponsor ID
- OPSTAR / OPSTAR
- Keywords
- cesarean section, repeat, uterine scar tissue, transvaginal ultrasound, uterine rupture, placenta accreta, placenta percreta, placenta increta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- Otto-von-Guericke University Magdeburg
- Study start
- Nov 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Mar 2016 (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.
This prospective, controlled, clinical, intervention study measures the number of uterine Cesarean section scars and median myometrial thickness of women who underwent two Cesarean sections six to nine months after their last Cesarean section using transvaginal ultrasound.
It is the purpose of the study to assess if a resection of the uterine scar from a previous Cesarean section during a second Cesarean section could lead to a decrease in risk for subsequent pregnancies.
Detailed description
The average number of Cesarean sections in Germany has doubled from 1991 to 2011, making up 32,1% of all deliveries in 2011.
Several studies describe instances in which pregnancies following a previous Cesarean section were accompanied by complications such as life-threatening bleeding, placenta previa, placenta accreta, increta or percreta and dehiscence or uterine rupture.
The risk of those complications increases further with the uterine scar tissue of a second Cesarean section.
Today it is already common practice to resect uterine scars if the scar of a previous Cesarean section becomes symptomatic, or when a non-symptomatic uterine rupture or serious dehiscence are discovered during a Cesarean delivery.
In this study all participants of the interventional group are examined via intraoperative ultrasound to identify the first uterine Cesarean section scar and resect it completely.
Six to nine months after the resection participants will return for a one time follow-up. At this time, the investigators will measure the number of uterine scars and median myometrial thickness using transvaginal ultrasound. The results will be compared with those of two control groups, consisting of women who underwent either one or two Cesarean sections without the intervention.
The aim of the present study is to asses if the number of uterine scars and median myometrial thickness can be improved by the resection of the first uterine scar during a subsequent Cesarean section.
This will allow the investigators to draw conclusions regarding the benefit of routine resections of uterine Cesarean section scars, and whether this practice could lead to a decreased risk for women undergoing two or more Cesarean sections.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 cesarean section | No intervention | –control group |
| 2 cesarean sections | No intervention | –control group |
| resection of uterine scar tissue | Experimental | Procedure: resection of uterine scar tissue2 cesarean sections with resection of uterine scar tissue from first cesarean section |
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)
- 18 years or older
- primary or secondary indication for cesarean section 6 to 9 months prior to the examination date
Key exclusion criteria (4 listed)
- <18 years old
- current pregnancy
- congenital deformity of the uterus
- former surgery of the uterine myometrium
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 |
|---|---|---|
| resection of uterine scar tissueresection of uterine scar tissue of a previous cesarean section during a second cesarean section | Procedure or surgery | resection of uterine scar tissue |
Primary outcome
number of uterine Cesarean section scars using transvaginal ultrasound
Time frame: 6-9 months
1 secondary outcome
median myometrial thickness of lower uterine segment using transvaginal ultrasound
Time frame: 6-9months
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 9 Sep 2016.
- 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.
Gregor Seliger, Dr. med. principal investigator
Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg
Michael Tchirikov, Prof. study chair
Maternity Clinic/Perinatal Treatment Center, Halle University Hospital, Martin-Luther-Universität Halle-Wittenberg
Serben-Dan Costa, Prof. principal investigator
Maternity Clinic, Magdeburg University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resection of uterine scar tissue in people with Scar; Previous Cesarean Section and Complications; Cesarean Section, Wound, Dehiscence, run by Martin-Luther-Universität Halle-Wittenberg at 2 sites in Germany.
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 4 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 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 uterine Cesarean section scars using transvaginal ultrasound (time frame: 6-9 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 9 Sep 2016; AzTrials last refreshed its copy on 8 Nov 2026.