Cesarean Section ComplicationsNCT03966001
Cesarean Scar Defect Formation After First Cesarean Section.
An observational study of Cesarean Section Complications and Cesarean Wound Disruption, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
This study is a prospective observational study which will monitor how cesarean section in the first pregnancy will develop a cesarean scar defect. Patients with planned cesarean section in their first pregnancy and those with an emergency cesarean section will be monitored for one year. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Cesarean Wound Disruption, Cesarean Wound; Dehiscence
- What is being tested?
- Transvaginal sonography at six months after cesarean section and Transvaginal sonography at twelve months after cesarean section
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2019to 15 Dec 2020
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population consists of pregnant patients who are in their 38-42th gestational weeks and who undergo planned or emergency cesarean section.
Who may be able to join
- 18-45-year-old patients
- Patients who have undergone a planned or emergency cesarean section within the 38-42th gestational week.
Who cannot join
- Spontaneous vaginal birth
- Preterm birth
- Pregnant women with an obstetrical or gynecological complication.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uludag University Hospital, Department of Obstetrics and Gynecology
Bursa, Ozluce, 16059
Adnan Orhan, M.D., +90 505 6337102, dr.adnan.orhan@hotmail.com
Ebru Sakar, M.D, +90 507 8517109, ebru_sakar@hotmail.com
About this study
Official title: Formation of the Cesarean Scar Defect After the First Cesarean. A Prospective Observational Study of Planned Versus Emergency Cesarean Sections
This study is a prospective observational study which will monitor how cesarean section in the first pregnancy will develop a cesarean scar defect. Patients with planned cesarean section in their first pregnancy and those with an emergency cesarean section will be monitored for one year.
Read the detailed description
Cesarean scar defects, which may develop after cesarean deliveries, are associated with menstrual bleeding problems, infertility, and poor obstetric outcomes. No matter how excellent and standard surgical technique is applied, scar defects may develop after cesarean section. However, when cesarean operation decision is taken, the existing operational conditions can affect the formation of cesarean scar defect in the future. Although the surgical technique is the same, a planned cesarean operation and an emergency cesarean section may differ for a future cesarean scar defect that may develop in the future.
- Being tested
- Transvaginal sonography at six months after cesarean section, Transvaginal sonography at twelve months after cesarean section
- Keywords
- Cesarean scar pregnancy, Isthmocele, Uterine niche, Cesarean scar defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal sonography at six months after cesarean sectionOther
Also called Transvaginal sonography 6th month after C/S
In the sixth month after cesarean section, Women in both groups will undergo a detailed pelvic examination and transvaginal ultrasonographic evaluation for the cesarean scar defect.
Transvaginal sonography at twelve months after cesarean sectionOther
Also called Transvaginal sonography 12th month after C/S
In the twelfth month after cesarean section, Women in both groups will undergo a detailed pelvic examination and transvaginal ultrasonographic evaluation for the cesarean scar defect.
| Study group | Role | What they receive |
|---|---|---|
| Planned Cesarean Group | Pregnant women undergoing a planned cesarean section at 38-42 gestational week. Receives: Other: Transvaginal sonography at six months after cesarean section; Other: Transvaginal sonography at twelve months after cesarean section | |
| Emergency Cesarean Group | Pregnant women who are planning to give normal birth between 38-42 weeks of gestation but have to been performed an urgent cesarean section due to an emergency such as acute fetal distress, cephalo-pelvic disproportion or another obstetrical condition. Receives: Other: Transvaginal sonography at six months after cesarean section; Other: Transvaginal sonography at twelve months after cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean Scar Defect (Niche)
The presence of a "niche" at the site of cesarean delivery scar diagnosed at the time of transvaginal ultrasonography
Measured: 10 minutes
Secondary outcomes (1)
Postmenstrual spotting
Any vaginal bleeding that occurs after the usual menstrual period.
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start25 Jun 2019
- Primary completion1 Jun 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Orhan, Uludag University
- Investigators
- Gurkan Uncu, Prof., Study director, Uludag University Hospital, 16059, Bursa, TurkeyBilge Cetinkaya Demır, Assoc.Prof., Principal investigator, Uludag University Hospital, 16059, Bursa, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966001
- Sponsor's protocol ID
- UU-SUAM-2019-8/34
- Status last verified
- Jun 2019
- First submitted
- 24 May 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data for all primary and secondary outcomes will be made available.
Publications
Antila-Langsjo R, Maenpaa JU, Huhtala H, Tomas E, Staff S. Comparison of transvaginal ultrasound and saline contrast sonohysterography in evaluation of cesarean scar defect: a prospective cohort study. Acta Obstet Gynecol Scand. 2018 Sep;97(9):1130-1136. doi: 10.1111/aogs.13367. Epub 2018 May 29.
PubMed 29754409Setubal A, Alves J, Osorio F, Guerra A, Fernandes R, Albornoz J, Sidiroupoulou Z. Treatment for Uterine Isthmocele, A Pouchlike Defect at the Site of a Cesarean Section Scar. J Minim Invasive Gynecol. 2018 Jan;25(1):38-46. doi: 10.1016/j.jmig.2017.09.022. Epub 2017 Oct 9.
PubMed 29024799Cali G, Timor-Tritsch IE, Palacios-Jaraquemada J, Monteaugudo A, Buca D, Forlani F, Familiari A, Scambia G, Acharya G, D'Antonio F. Outcome of Cesarean scar pregnancy managed expectantly: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Feb;51(2):169-175. doi: 10.1002/uog.17568.
PubMed 28661021Antila-Langsjo RM, Maenpaa JU, Huhtala HS, Tomas EI, Staff SM. Cesarean scar defect: a prospective study on risk factors. Am J Obstet Gynecol. 2018 Nov;219(5):458.e1-458.e8. doi: 10.1016/j.ajog.2018.09.004. Epub 2018 Sep 18.
PubMed 30240650Ades A, Parghi S. Laparoscopic Resection of Cesarean Scar Ectopic Pregnancy. J Minim Invasive Gynecol. 2017 May-Jun;24(4):533-535. doi: 10.1016/j.jmig.2016.11.006. Epub 2016 Nov 17.
PubMed 27867050
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formation of the Cesarean Scar Defect After the First Cesarean. A Prospective Observational Study of Planned Versus Emergency Cesarean Sections
- ClinicalTrials.gov ID
- NCT03966001
- Acronym / sponsor ID
- UU-SUAM-2019-8/34
- Keywords
- Cesarean scar pregnancy, Isthmocele, Uterine niche, Cesarean scar defect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 29 May 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.
This study is a prospective observational study which will monitor how cesarean section in the first pregnancy will develop a cesarean scar defect. Patients with planned cesarean section in their first pregnancy and those with an emergency cesarean section will be monitored for one year.
Detailed description
Cesarean scar defects, which may develop after cesarean deliveries, are associated with menstrual bleeding problems, infertility, and poor obstetric outcomes. No matter how excellent and standard surgical technique is applied, scar defects may develop after cesarean section. However, when cesarean operation decision is taken, the existing operational conditions can affect the formation of cesarean scar defect in the future. Although the surgical technique is the same, a planned cesarean operation and an emergency cesarean section may differ for a future cesarean scar defect that may develop in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Planned Cesarean Group | – | Other: Transvaginal sonography at six months after cesarean section, Other: Transvaginal sonography at twelve months after cesarean sectionPregnant women undergoing a planned cesarean section at 38-42 gestational week. |
| Emergency Cesarean Group | – | Other: Transvaginal sonography at six months after cesarean section, Other: Transvaginal sonography at twelve months after cesarean sectionPregnant women who are planning to give normal birth between 38-42 weeks of gestation but have to been performed an urgent cesarean section due to an emergency such as acute fetal distress, cephalo-pelvic disproportion or another obstetrical condition. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of pregnant patients who are in their 38-42th gestational weeks and who undergo planned or emergency cesarean section.
Key inclusion criteria (2 listed)
- 18-45-year-old patients
- Patients who have undergone a planned or emergency cesarean section within the 38-42th gestational week.
Key exclusion criteria (3 listed)
- Spontaneous vaginal birth
- Preterm birth
- Pregnant women with an obstetrical or gynecological complication.
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 |
|---|---|---|
| Transvaginal sonography at six months after cesarean sectionAlso: Transvaginal sonography 6th month after C/SIn the sixth month after cesarean section, Women in both groups will undergo a detailed pelvic examination and transvaginal ultrasonographic evaluation for the cesarean scar defect. | Other | Emergency Cesarean Group, Planned Cesarean Group |
| Transvaginal sonography at twelve months after cesarean sectionAlso: Transvaginal sonography 12th month after C/SIn the twelfth month after cesarean section, Women in both groups will undergo a detailed pelvic examination and transvaginal ultrasonographic evaluation for the cesarean scar defect. | Other | Emergency Cesarean Group, Planned Cesarean Group |
Primary outcome
Cesarean Scar Defect (Niche)
Time frame: 10 minutes
The presence of a "niche" at the site of cesarean delivery scar diagnosed at the time of transvaginal ultrasonography
1 secondary outcome
Postmenstrual spotting
Time frame: 7-10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Background: PubMed 29754409Antila-Langsjo R, Maenpaa JU, Huhtala H, Tomas E, Staff S. Comparison of transvaginal ultrasound and saline contrast sonohysterography in evaluation of cesarean scar defect: a prospective cohort study. Acta Obstet Gynecol Scand. 2018 Sep;97(9):1130-1136. doi: 10.1111/aogs.13367. Epub 2018 May 29.
- Background: PubMed 29024799Setubal A, Alves J, Osorio F, Guerra A, Fernandes R, Albornoz J, Sidiroupoulou Z. Treatment for Uterine Isthmocele, A Pouchlike Defect at the Site of a Cesarean Section Scar. J Minim Invasive Gynecol. 2018 Jan;25(1):38-46. doi: 10.1016/j.jmig.2017.09.022. Epub 2017 Oct 9.
- Background: PubMed 28661021Cali G, Timor-Tritsch IE, Palacios-Jaraquemada J, Monteaugudo A, Buca D, Forlani F, Familiari A, Scambia G, Acharya G, D'Antonio F. Outcome of Cesarean scar pregnancy managed expectantly: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Feb;51(2):169-175. doi: 10.1002/uog.17568.
- Results publication: PubMed 30240650Antila-Langsjo RM, Maenpaa JU, Huhtala HS, Tomas EI, Staff SM. Cesarean scar defect: a prospective study on risk factors. Am J Obstet Gynecol. 2018 Nov;219(5):458.e1-458.e8. doi: 10.1016/j.ajog.2018.09.004. Epub 2018 Sep 18.
- Results publication: PubMed 27867050Ades A, Parghi S. Laparoscopic Resection of Cesarean Scar Ectopic Pregnancy. J Minim Invasive Gynecol. 2017 May-Jun;24(4):533-535. doi: 10.1016/j.jmig.2016.11.006. Epub 2016 Nov 17.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data for all primary and secondary outcomes will be made available.
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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.
Gurkan Uncu, Prof. study director
Uludag University Hospital, 16059, Bursa, Turkey
Bilge Cetinkaya Demır, Assoc.Prof. principal investigator
Uludag University Hospital, 16059, Bursa, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications and Cesarean Wound Disruption, run by Uludag University at 1 site in Turkey (Türkiye).
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 26 Jun 2019. 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 Turkey (Türkiye). 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 Adnan Orhan, M.D. (+905056337102, dr.adnan.orhan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean Scar Defect (Niche) (time frame: 10 minutes). 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 NCT03966001, which also lists 5 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 26 Jun 2019.