Cesarean Section; DehiscenceNCT03859258
Ultrasound Based Study For Niche Development In The Uterine Cesarean Section Scar
An observational study of Cesarean Section; Dehiscence, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate different factors affecting niche development in the uterine cesarean section scar in women enrolled 3 to 6 months after cesarean delivery using both TVS and SIS. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cesarean Section; Dehiscence
- What is being tested?
- Transvaginal sonography
- Type of treatment
- Medical device
- How many people
- 221 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 30 Jul 2019
- How long will I take part?
- 3 Months
- 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 20 to 40 years
- Women only
- Adult
Study population: Pregnant women
Who may be able to join
- Cases are delivered by Lower segment cesarean section
- Controls are delivered vaginally
- Singleton fetus
- Living fetus
- Term pregnancy
Who cannot join
- Placenta praevia
- Congenital fetal anomalies
- Severe oligohydramnios(MVP <2cm)
- Rupture of membranes more than 18 hours
- Puerperal pyrexia or sepsis
- Bladder injury
- Blood transfusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Controlled Ultrasound Based Study For Niche Development In The Uterine Cesarean Section Scar With Hysteroscopic Correlation In Symptomatizing Patients
The aim of this study is to evaluate different factors affecting niche development in the uterine cesarean section scar in women enrolled 3 to 6 months after cesarean delivery using both TVS and SIS.
Read the detailed description
Cesarean delivery is amongst the most widely recognized operations performed on women and its rate continue expanding. The rates of cesarean section (CS) in the United States in 1996 and 2009 were 20.7% and 32.3% respectively, witnessing an expansion of more than half. In China, 50% of deliveries in 2010 were through CS. In the Netherlands, the cesarean delivery rate jumped from 7.4 to 15.8% between 1990 and 2008, whereas in the United Kingdom, the CS rate increased from 12 to 29% throughout the same time period. In Brazil, the CS rate jumped from 15% in 1970 to even 80% in 2004.
The expanding rate of cesarean deliveries can be credited to many variables including an increase in repeated cesarean sections. There is no discourse that CS is a lifesaving method for a few women, for instance for women with placenta previa or obstructed labor, or for fetuses with either antenatal or intrapartum distress, breech pregnancy or a twin pregnancy. The World Health Organization suggests that the ideal CS rate should be 15%.
Also, this expanding CS rate has fortified an enthusiasm for the potential long-term morbidity of CS scars. By and large, the cesarean incision heals uneventfully. However, some authors depicted a cesarean scar defect on transvaginal sonography (TVS) or saline infusion sonography (SIS) as a wedge shape anechoic structure at the site of the scar or a gap in anterior myometrium of the anterior lower myometrium at the site of previous cesarean section site. This was first described using hysterosalpingography in 1961. The terminology used to describe these scar abnormalities include scar defects, or 'niches' in the uterine scar, cesarean scar defect, uterine diverticulum, uterine isthmocele, pouch or sacculation and differs various publications. The term 'niche', which was introduced in 2001. A niche appears to be frequently present after a CS. Using SIS, niches were identified in the scar in more than half of the women who had had a caesarean delivery. Niches were defined as indentations of the myometrium of at least 2 mm. Large niches occur less frequently, with an incidence varying from 11 to 45% dependent on the definition used (a depth of at least 50 or 80% of the anterior myometrium, or the remaining myometrial thickness ≤2.2 mm when evaluated by TVS and ≤2.5 mm when evaluated by sonohysterography).
It is usually asymptomatic. Be that as it may, some authors have described some symptoms identified with this condition and there are several studies relating abnormal uterine bleeding and niche, especially postmenstrual spotting which appears to be the most common symptom in women with niches due to the collection of menstrual blood in a uterine scar defect causing postmenstrual spotting.
Later prospective cohort studies reported spotting in ∼30% of women with a niche at 6- 12 months after their CS compared with 15% of women without a niche after CS. It is undoubtedly a generally new pathology that needs assessment.
- Conditions
- Cesarean Section; Dehiscence
- Being tested
- Transvaginal sonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal sonographyDevice
Also called SIS, office hysteroscopy
Niche is assessed using TVS, SIS (cases only) and office hysteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Patient having Cesarean section | Transvaginal sonography for patients having ceserean section to assess uterine Niche development and parameters Receives: Device: Transvaginal sonography | |
| Patient delivered vaginally | Transvaginal sonography for patients having vaginal delivery to confirm absence of uterine Niche development Receives: Device: Transvaginal sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Niche development in the uterine cesarean section scar
Measure number of patients that will develop uterine Niche following lower segment cesarean section
Measured: baseline
Secondary outcomes (6)
Measuring Residual myometrial thickness (RMT)
Measuring the remaining myometrium above uterine Niche
Measured: baseline
Measuring depth of uterine Niche
Measuring the depth of cesarean scar defect developed after cesarean section
Measured: baseline
Measuring width of uterine Niche
Measuring the width of cesarean scar defect developed after cesarean section
Measured: baseline
Assessment of potential risk factors for Niche development
Detect why Niche develop
Measured: baseline
Rate of postmenstrual spotting in patients with uterine Niche
Measure number of patients having uterine Niche that will complain from postmenstrual spotting
Measured: baseline
Rate of uterine Isthmocele development on hysteroscopic evaluation in patients presenting with postmenstrual spotting after cesarean section
Measure number of patients having uterine Isthmocele detected during hysteroscopic evaluation from all patients presenting with postmenstrual spotting
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Jul 2017
- Primary completion30 Jun 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section; DehiscenceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Raafat Abdelfatah Mohamed Said, Cairo University
- Investigators
- Mona M Aboulghar, M.D., Principal investigator, Cairo UniversityHassan M Gaafar, M.D., Principal investigator, Cairo UniversityHisham M Haggag, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859258
- Sponsor's protocol ID
- CSD1
- Status last verified
- Oct 2021
- First submitted
- 26 Feb 2019
- Last updated
- 18 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barros AJ, Santos IS, Matijasevich A, Domingues MR, Silveira M, Barros FC, Victora CG. Patterns of deliveries in a Brazilian birth cohort: almost universal cesarean sections for the better-off. Rev Saude Publica. 2011 Aug;45(4):635-43. doi: 10.1590/s0034-89102011005000039. Epub 2011 Jun 10.
PubMed 21670862Betran AP, Merialdi M, Lauer JA, Bing-Shun W, Thomas J, Van Look P, Wagner M. Rates of caesarean section: analysis of global, regional and national estimates. Paediatr Perinat Epidemiol. 2007 Mar;21(2):98-113. doi: 10.1111/j.1365-3016.2007.00786.x.
PubMed 17302638Bij de Vaate AJ, Brolmann HA, van der Voet LF, van der Slikke JW, Veersema S, Huirne JA. Ultrasound evaluation of the Cesarean scar: relation between a niche and postmenstrual spotting. Ultrasound Obstet Gynecol. 2011 Jan;37(1):93-9. doi: 10.1002/uog.8864.
PubMed 21031351Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.
PubMed 23996650Clark EA, Silver RM. Long-term maternal morbidity associated with repeat cesarean delivery. Am J Obstet Gynecol. 2011 Dec;205(6 Suppl):S2-10. doi: 10.1016/j.ajog.2011.09.028. Epub 2011 Oct 6.
PubMed 22114995Deng W, Klemetti R, Long Q, Wu Z, Duan C, Zhang WH, Ronsmans C, Zhang Y, Hemminki E. Cesarean section in Shanghai: women's or healthcare provider's preferences? BMC Pregnancy Childbirth. 2014 Aug 22;14:285. doi: 10.1186/1471-2393-14-285.
PubMed 25148697Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Sep 25.
PubMed 26409016Feng XL, Wang Y, An L, Ronsmans C. Cesarean section in the People's Republic of China: current perspectives. Int J Womens Health. 2014 Jan 9;6:59-74. doi: 10.2147/IJWH.S41410. eCollection 2014.
PubMed 24470775Hofmeyr GJ, Hannah M, Lawrie TA. Planned caesarean section for term breech delivery. Cochrane Database Syst Rev. 2015 Jul 21;2015(7):CD000166. doi: 10.1002/14651858.CD000166.pub2.
PubMed 26196961Monteagudo A, Carreno C, Timor-Tritsch IE. Saline infusion sonohysterography in nonpregnant women with previous cesarean delivery: the "niche" in the scar. J Ultrasound Med. 2001 Oct;20(10):1105-15. doi: 10.7863/jum.2001.20.10.1105.
PubMed 11587017Naji O, Abdallah Y, Bij De Vaate AJ, Smith A, Pexsters A, Stalder C, McIndoe A, Ghaem-Maghami S, Lees C, Brolmann HA, Huirne JA, Timmerman D, Bourne T. Standardized approach for imaging and measuring Cesarean section scars using ultrasonography. Ultrasound Obstet Gynecol. 2012 Mar;39(3):252-9. doi: 10.1002/uog.10077.
PubMed 21858885Osser OV, Jokubkiene L, Valentin L. High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2009 Jul;34(1):90-7. doi: 10.1002/uog.6395.
PubMed 19499514Osterman MJ, Martin JA. Primary cesarean delivery rates, by state: results from the revised birth certificate, 2006-2012. Natl Vital Stat Rep. 2014 Jan;63(1):1-11.
PubMed 24461076POIDEVIN LO. The value of hysterography in the prediction of cesarean section wound defects. Am J Obstet Gynecol. 1961 Jan;81:67-71. doi: 10.1016/s0002-9378(16)36308-6. No abstract available.
PubMed 13736585Roberts CL, Algert CS, Nippita TA, Bowen JR, Shand AW. Association of prelabor cesarean delivery with reduced mortality in twins born near term. Obstet Gynecol. 2015 Jan;125(1):103-110. doi: 10.1097/AOG.0000000000000578.
PubMed 25560111
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Controlled Ultrasound Based Study For Niche Development In The Uterine Cesarean Section Scar With Hysteroscopic Correlation In Symptomatizing Patients
- ClinicalTrials.gov ID
- NCT03859258
- Acronym / sponsor ID
- CSD1
- Conditions
- Cesarean Section; Dehiscence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 1 Mar 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.
The aim of this study is to evaluate different factors affecting niche development in the uterine cesarean section scar in women enrolled 3 to 6 months after cesarean delivery using both TVS and SIS.
Detailed description
Cesarean delivery is amongst the most widely recognized operations performed on women and its rate continue expanding. The rates of cesarean section (CS) in the United States in 1996 and 2009 were 20.7% and 32.3% respectively, witnessing an expansion of more than half. In China, 50% of deliveries in 2010 were through CS. In the Netherlands, the cesarean delivery rate jumped from 7.4 to 15.8% between 1990 and 2008, whereas in the United Kingdom, the CS rate increased from 12 to 29% throughout the same time period. In Brazil, the CS rate jumped from 15% in 1970 to even 80% in 2004.
The expanding rate of cesarean deliveries can be credited to many variables including an increase in repeated cesarean sections. There is no discourse that CS is a lifesaving method for a few women, for instance for women with placenta previa or obstructed labor, or for fetuses with either antenatal or intrapartum distress, breech pregnancy or a twin pregnancy. The World Health Organization suggests that the ideal CS rate should be 15%.
Also, this expanding CS rate has fortified an enthusiasm for the potential long-term morbidity of CS scars. By and large, the cesarean incision heals uneventfully. However, some authors depicted a cesarean scar defect on transvaginal sonography (TVS) or saline infusion sonography (SIS) as a wedge shape anechoic structure at the site of the scar or a gap in anterior myometrium of the anterior lower myometrium at the site of previous cesarean section site. This was first described using hysterosalpingography in 1961. The terminology used to describe these scar abnormalities include scar defects, or 'niches' in the uterine scar, cesarean scar defect, uterine diverticulum, uterine isthmocele, pouch or sacculation and differs various publications. The term 'niche', which was introduced in 2001. A niche appears to be frequently present after a CS. Using SIS, niches were identified in the scar in more than half of the women who had had a caesarean delivery. Niches were defined as indentations of the myometrium of at least 2 mm. Large niches occur less frequently, with an incidence varying from 11 to 45% dependent on the definition used (a depth of at least 50 or 80% of the anterior myometrium, or the remaining myometrial thickness ≤2.2 mm when evaluated by TVS and ≤2.5 mm when evaluated by sonohysterography).
It is usually asymptomatic. Be that as it may, some authors have described some symptoms identified with this condition and there are several studies relating abnormal uterine bleeding and niche, especially postmenstrual spotting which appears to be the most common symptom in women with niches due to the collection of menstrual blood in a uterine scar defect causing postmenstrual spotting.
Later prospective cohort studies reported spotting in ∼30% of women with a niche at 6- 12 months after their CS compared with 15% of women without a niche after CS. It is undoubtedly a generally new pathology that needs assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient having Cesarean section | – | Device: Transvaginal sonographyTransvaginal sonography for patients having ceserean section to assess uterine Niche development and parameters |
| Patient delivered vaginally | – | Device: Transvaginal sonographyTransvaginal sonography for patients having vaginal delivery to confirm absence of uterine Niche development |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (5 listed)
- Cases are delivered by Lower segment cesarean section
- Controls are delivered vaginally
- Singleton fetus
- Living fetus
- Term pregnancy
Key exclusion criteria (7 listed)
- Placenta praevia
- Congenital fetal anomalies
- Severe oligohydramnios(MVP <2cm)
- Rupture of membranes more than 18 hours
- Puerperal pyrexia or sepsis
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 sonographyAlso: SIS, office hysteroscopyNiche is assessed using TVS, SIS (cases only) and office hysteroscopy | Device | Patient delivered vaginally, Patient having Cesarean section |
Primary outcome
Rate of Niche development in the uterine cesarean section scar
Time frame: baseline
Measure number of patients that will develop uterine Niche following lower segment cesarean section
6 secondary outcomes
Measuring Residual myometrial thickness (RMT)
Time frame: baseline
Measuring depth of uterine Niche
Time frame: baseline
Measuring width of uterine Niche
Time frame: baseline
Assessment of potential risk factors for Niche development
Time frame: baseline
Rate of postmenstrual spotting in patients with uterine Niche
Time frame: baseline
Rate of uterine Isthmocele development on hysteroscopic evaluation in patients presenting with postmenstrual spotting after cesarean section
Time frame: basline
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 18 Oct 2021.
- Background: PubMed 21670862Barros AJ, Santos IS, Matijasevich A, Domingues MR, Silveira M, Barros FC, Victora CG. Patterns of deliveries in a Brazilian birth cohort: almost universal cesarean sections for the better-off. Rev Saude Publica. 2011 Aug;45(4):635-43. doi: 10.1590/s0034-89102011005000039. Epub 2011 Jun 10.
- Background: PubMed 17302638Betran AP, Merialdi M, Lauer JA, Bing-Shun W, Thomas J, Van Look P, Wagner M. Rates of caesarean section: analysis of global, regional and national estimates. Paediatr Perinat Epidemiol. 2007 Mar;21(2):98-113. doi: 10.1111/j.1365-3016.2007.00786.x.
- Background: PubMed 21031351Bij de Vaate AJ, Brolmann HA, van der Voet LF, van der Slikke JW, Veersema S, Huirne JA. Ultrasound evaluation of the Cesarean scar: relation between a niche and postmenstrual spotting. Ultrasound Obstet Gynecol. 2011 Jan;37(1):93-9. doi: 10.1002/uog.8864.
- Background: PubMed 23996650Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.
- Background: PubMed 22114995Clark EA, Silver RM. Long-term maternal morbidity associated with repeat cesarean delivery. Am J Obstet Gynecol. 2011 Dec;205(6 Suppl):S2-10. doi: 10.1016/j.ajog.2011.09.028. Epub 2011 Oct 6.
- Background: PubMed 25148697Deng W, Klemetti R, Long Q, Wu Z, Duan C, Zhang WH, Ronsmans C, Zhang Y, Hemminki E. Cesarean section in Shanghai: women's or healthcare provider's preferences? BMC Pregnancy Childbirth. 2014 Aug 22;14:285. doi: 10.1186/1471-2393-14-285.
- Background: PubMed 26409016Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Sep 25.
- Background: PubMed 24470775Feng XL, Wang Y, An L, Ronsmans C. Cesarean section in the People's Republic of China: current perspectives. Int J Womens Health. 2014 Jan 9;6:59-74. doi: 10.2147/IJWH.S41410. eCollection 2014.
- Background: PubMed 26196961Hofmeyr GJ, Hannah M, Lawrie TA. Planned caesarean section for term breech delivery. Cochrane Database Syst Rev. 2015 Jul 21;2015(7):CD000166. doi: 10.1002/14651858.CD000166.pub2.
- Background: PubMed 11587017Monteagudo A, Carreno C, Timor-Tritsch IE. Saline infusion sonohysterography in nonpregnant women with previous cesarean delivery: the "niche" in the scar. J Ultrasound Med. 2001 Oct;20(10):1105-15. doi: 10.7863/jum.2001.20.10.1105.
- Background: PubMed 21858885Naji O, Abdallah Y, Bij De Vaate AJ, Smith A, Pexsters A, Stalder C, McIndoe A, Ghaem-Maghami S, Lees C, Brolmann HA, Huirne JA, Timmerman D, Bourne T. Standardized approach for imaging and measuring Cesarean section scars using ultrasonography. Ultrasound Obstet Gynecol. 2012 Mar;39(3):252-9. doi: 10.1002/uog.10077.
- Background: PubMed 19499514Osser OV, Jokubkiene L, Valentin L. High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2009 Jul;34(1):90-7. doi: 10.1002/uog.6395.
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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.
Mona M Aboulghar, M.D. principal investigator
Cairo University
Hassan M Gaafar, M.D. principal investigator
Cairo University
Hisham M Haggag, M.D. principal investigator
Cairo University
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; Dehiscence, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 7 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 18 Oct 2021. 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 Egypt. 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?
Rate of Niche development in the uterine cesarean section scar (time frame: baseline). 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 NCT03859258, which also lists 19 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 18 Oct 2021.