Previous Cesarean Section ScarNCT04856254
Clinical and Ultrasound Score for Evaluation of Previous Cesarean Section Scar
A study testing Trial of labor after cesarean section in people with Previous Cesarean Section Scar, run by Mansoura University at 1 site in Egypt.
Trial summary
Cesarean delivery rates have increased dramatically worldwide. In the United States, cesarean section (CS) rates increased from 5% of all deliveries in 1970 to a high of 31.9% in 2016.Although efforts were made to reduce the number of CS, it failed to achieve the 15% rate recommended by the World Health Organization… Read more about this study
- Who is it for?
- Ages 17 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Previous Cesarean Section Scar
- What is being tested?
- Trial of labor after cesarean section
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 1 Sep 2021
- 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 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Previous one cesarean section for non permenant indication.
- Pregnant women without any medical disorders.
- Gestational age: 36-40 weeks.
- Pregnant woman with singleton pregnancy.
- Clinically adequate pelvis.
- Normal ultrasonographic findings (gestational age, fetal structures and placental site).
- Cephalic vertex presentation.
- Patients not inlabour.
Who cannot join
- Previous repair of ruptured uterus.
- Women with history of long-term treatment for infertility.
- Multiple pregnancies.
- Previous operations in uterus rather than cesarean section.
- Polyhydramnios and Fetal macrosomia.
- Women with bad obstetric history (previous IUFD or difficult delivery).
- Disturbance of fetal heart rate (determined with the CTG).
Trial locations and contacts
1 site in 1 country.
About this study
Cesarean delivery rates have increased dramatically worldwide. In the United States, cesarean section (CS) rates increased from 5% of all deliveries in 1970 to a high of 31.9% in 2016.Although efforts were made to reduce the number of CS, it failed to achieve the 15% rate recommended by the World Health Organization (WHO).Repeat CS is the most significant factor contributing to overall increased CS rates. The primary indication of repeat CS is a prior CS. The trial of labor after cesarean (TOLAC) is an attempt to reduce CS rates. Several national medical associations have provided practice guidelines for vaginal birth after cesarean section (VBAC), but these differ across countries.VBAC is relatively safe when compared with repeat CS.However, TOLAC rates have dropped significantly worldwide in recent years.
Read the detailed description
Brief History taking include: age of patient, gravidity, parity, time interval between previous cesarean sections and current pregnancy, indication for the previous cesarean section, and fetal weight of previous delivery with special emphasis on menstrual history for proper dating and history of previous pregnancy to verify the inclusion or exclusion criteria.Physical examination include : General examination: for exclusion of presence of any medical disorders,Obstetric examination include: Fundal level to correlate with gestational age known by history, Umbilical grip to verify inclusion and exclusion criteria, Scar tenderness and shape in women who had undergone a previous cesarean section and investigations that will be performed including the following:basic routine antenatal investigations of pregnant women including blood group,Rhesus factor, complete blood count, blood sugar, and urine analysis. abdominal and transvaginal ultrasound will be performed for:a complete obstetric assessment at full term using TAS to confirm gestational age, fetal vitality, lie and presentation, amniotic fluid and placental position.Evaluation of the lower uterine segment using TVS, by measuring its thickness and identifying the echo structure for beinghomogenous or not . The LUS will be visualized in the sagittal section in the midline and lateral plane. The measurement will be obtained with the cursors at the urinary bladder wall- myometrium interface and the myometrium chorioamniotic membrane-amniotic fluid interface. Three layers can be identified by ultrasonography in a well-developed LUS in a midline section of sagittal view in a partially filled bladder. They are as follows from inside outwards:Chorioamniotic membrane with decidualized endometrium, a middle layer of myometrium and utero-vesical peritoneal reflection juxtaposed to muscularis and mucosa of the bladder.The lower uterine segment will be visualized in sagittal section in the midline.There after :150 patients will be evaluated using a measurement value of the clinical and ultrasound criteria and Follow up of all participants will be followed up till delivery, the mode of delivery either VBAC or elective repeated lower segment CS according to:History and clinical examination evaluation: Previous complicated CS or not, time interval between previous cesarean sections and current pregnancy(less than one year or more than one year),tender scar or not. US : TAS and TVS include: Lower uterine segment thickness , The echo structure of the lower uterine segment (Homogenous or nonHomogenous). For follow up of patient with previous CS include Initial evaluation: Each of the clinical and US parameters will be scored based on the sum of points is shown in table whatever to complete delivery by natural means or again by cesarean section.If the score is more than 7 out of 10 a vaginal birth will tried. On the other hand,Score 7 or less than 7 will be considered an indication to do repeated elective cesarean section.Careful follow up of patient during trial of labor after CS [TOLAC] for any possible symptoms and signs of uterine rupture that require immediate surgical intervention like : bleeding either intra abdominal or vaginal,cessation of uterine contraction,abnormal uterine contour,abdominal distention,shoulder tip pain,supraoubic pain,sudden severe abdominal pain may decrease after rupture,tender abdomen,rapid materinal pulse, low blood pressure,hypovolomic shock if rupture involve major blood vessels,no fetal presentation on vaginal examination,prolonged fetal bradycardia and absent fetal heart activity during continuous electronic heart rate monitoring.Careful examination of patient after vaginal delivery to detect any maternal complication by: local examination under anesthesia to ensure continuity of cesarean scar and ultrasound evaluation of scar.The parameters that are evaluated by clinical and ultrasound criteria Clinical and ultrasound criteria SCORE (2) SCORE (1)Tender scar Not tender (2) Tender (1)Previous complicated CS Not complicated (2) Complicated (1) ,Echo structure of the LUS Homogenous (2) Non homogenous (1)Lower uterine segment thickness More than or equal 3.65 mm(2) .more than 3mm to less than 3.65 mm(1)Pregnancy time interval after the CS More than 12 months(2) 12 months or less(1)Total Score (10) (5)
- Conditions
- Previous Cesarean Section Scar
- Being tested
- Trial of labor after cesarean section
- Keywords
- Trial of labor after cesarean section(TOLAC)& vaginal birth after cesarean section (VBAC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trial of labor after cesarean sectionProcedure or surgery
Also called Elective repeated cesarean section
The pregnant females with history of previous cesarean section will be classified according to clinical and ultrasound score as patient suitable to undergo trial of labor after CS [TOLAC]or not suitable for [TOLAC] so undergo from the beginning to elective repeated cesarean section.
What is being measured
The primary outcome is the main question the study is designed to answer.
Novel score (Mosbah) score for evaluation of previous cesarean section scar
The aim of this study is to use a novel score (Mosbah score) for evaluation of previous cesarean section scar in pregnant women in order to select the best and most safe mode of delivery by using certain measurments based on clinical findings and ultrasound measurements.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Aug 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Previous Cesarean Section ScarStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Elsaeed Elgohary, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856254
- Sponsor's protocol ID
- previous cesarean section scar
- Status last verified
- Sep 2021
- First submitted
- 14 Apr 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martin JA, Hamilton BE, Osterman MJK. Births in the United States, 2016. NCHS Data Brief. 2017 Sep;(287):1-8.
PubMed 29155684World Health Organization Human Reproduction Programme, 10 April 2015. WHO Statement on caesarean section rates. Reprod Health Matters. 2015 May;23(45):149-50. doi: 10.1016/j.rhm.2015.07.007. Epub 2015 Jul 27. No abstract available.
PubMed 26278843Cheng YW, Eden KB, Marshall N, Pereira L, Caughey AB, Guise JM. Delivery after prior cesarean: maternal morbidity and mortality. Clin Perinatol. 2011 Jun;38(2):297-309. doi: 10.1016/j.clp.2011.03.012.
PubMed 21645797Foureur M, Ryan CL, Nicholl M, Homer C. Inconsistent evidence: analysis of six national guidelines for vaginal birth after cesarean section. Birth. 2010 Mar;37(1):3-10. doi: 10.1111/j.1523-536X.2009.00372.x.
PubMed 20402716
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Ultrasound Score for Evaluation of Previous Cesarean Section Scar
- ClinicalTrials.gov ID
- NCT04856254
- Acronym / sponsor ID
- previous cesarean section scar
- Conditions
- Previous Cesarean Section Scar
- Keywords
- Trial of labor after cesarean section(TOLAC)& vaginal birth after cesarean section (VBAC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 23 Apr 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.
Cesarean delivery rates have increased dramatically worldwide. In the United States, cesarean section (CS) rates increased from 5% of all deliveries in 1970 to a high of 31.9% in 2016.Although efforts were made to reduce the number of CS, it failed to achieve the 15% rate recommended by the World Health Organization (WHO).Repeat CS is the most significant factor contributing to overall increased CS rates. The primary indication of repeat CS is a prior CS. The trial of labor after cesarean (TOLAC) is an attempt to reduce CS rates. Several national medical associations have provided practice guidelines for vaginal birth after cesarean section (VBAC), but these differ across countries.VBAC is relatively safe when compared with repeat CS.However, TOLAC rates have dropped significantly worldwide in recent years.
Detailed description
Brief History taking include: age of patient, gravidity, parity, time interval between previous cesarean sections and current pregnancy, indication for the previous cesarean section, and fetal weight of previous delivery with special emphasis on menstrual history for proper dating and history of previous pregnancy to verify the inclusion or exclusion criteria.Physical examination include : General examination: for exclusion of presence of any medical disorders,Obstetric examination include: Fundal level to correlate with gestational age known by history, Umbilical grip to verify inclusion and exclusion criteria, Scar tenderness and shape in women who had undergone a previous cesarean section and investigations that will be performed including the following:basic routine antenatal investigations of pregnant women including blood group,Rhesus factor, complete blood count, blood sugar, and urine analysis. abdominal and transvaginal ultrasound will be performed for:a complete obstetric assessment at full term using TAS to confirm gestational age, fetal vitality, lie and presentation, amniotic fluid and placental position.Evaluation of the lower uterine segment using TVS, by measuring its thickness and identifying the echo structure for beinghomogenous or not . The LUS will be visualized in the sagittal section in the midline and lateral plane. The measurement will be obtained with the cursors at the urinary bladder wall- myometrium interface and the myometrium chorioamniotic membrane-amniotic fluid interface. Three layers can be identified by ultrasonography in a well-developed LUS in a midline section of sagittal view in a partially filled bladder. They are as follows from inside outwards:Chorioamniotic membrane with decidualized endometrium, a middle layer of myometrium and utero-vesical peritoneal reflection juxtaposed to muscularis and mucosa of the bladder.The lower uterine segment will be visualized in sagittal section in the midline.There after :150 patients will be evaluated using a measurement value of the clinical and ultrasound criteria and Follow up of all participants will be followed up till delivery, the mode of delivery either VBAC or elective repeated lower segment CS according to:History and clinical examination evaluation: Previous complicated CS or not, time interval between previous cesarean sections and current pregnancy(less than one year or more than one year),tender scar or not. US : TAS and TVS include: Lower uterine segment thickness , The echo structure of the lower uterine segment (Homogenous or nonHomogenous). For follow up of patient with previous CS include Initial evaluation: Each of the clinical and US parameters will be scored based on the sum of points is shown in table whatever to complete delivery by natural means or again by cesarean section.If the score is more than 7 out of 10 a vaginal birth will tried. On the other hand,Score 7 or less than 7 will be considered an indication to do repeated elective cesarean section.Careful follow up of patient during trial of labor after CS [TOLAC] for any possible symptoms and signs of uterine rupture that require immediate surgical intervention like : bleeding either intra abdominal or vaginal,cessation of uterine contraction,abnormal uterine contour,abdominal distention,shoulder tip pain,supraoubic pain,sudden severe abdominal pain may decrease after rupture,tender abdomen,rapid materinal pulse, low blood pressure,hypovolomic shock if rupture involve major blood vessels,no fetal presentation on vaginal examination,prolonged fetal bradycardia and absent fetal heart activity during continuous electronic heart rate monitoring.Careful examination of patient after vaginal delivery to detect any maternal complication by: local examination under anesthesia to ensure continuity of cesarean scar and ultrasound evaluation of scar.The parameters that are evaluated by clinical and ultrasound criteria Clinical and ultrasound criteria SCORE (2) SCORE (1)Tender scar Not tender (2) Tender (1)Previous complicated CS Not complicated (2) Complicated (1) ,Echo structure of the LUS Homogenous (2) Non homogenous (1)Lower uterine segment thickness More than or equal 3.65 mm(2) .more than 3mm to less than 3.65 mm(1)Pregnancy time interval after the CS More than 12 months(2) 12 months or less(1)Total Score (10) (5)
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Previous one cesarean section for non permenant indication.
- Pregnant women without any medical disorders.
- Gestational age: 36-40 weeks.
- Pregnant woman with singleton pregnancy.
- Clinically adequate pelvis.
Key exclusion criteria (7 listed)
- Previous repair of ruptured uterus.
- Women with history of long-term treatment for infertility.
- Multiple pregnancies.
- Previous operations in uterus rather than cesarean section.
- Polyhydramnios and Fetal macrosomia.
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 |
|---|---|---|
| Trial of labor after cesarean sectionAlso: Elective repeated cesarean sectionThe pregnant females with history of previous cesarean section will be classified according to clinical and ultrasound score as patient suitable to undergo trial of labor after CS [TOLAC]or not suitable for [TOLAC] so undergo from the beginning to elective repeated cesarean section. | Procedure or surgery | – |
Primary outcome
Novel score (Mosbah) score for evaluation of previous cesarean section scar
Time frame: Baseline
The aim of this study is to use a novel score (Mosbah score) for evaluation of previous cesarean section scar in pregnant women in order to select the best and most safe mode of delivery by using certain measurments based on clinical findings and ultrasound measurements.
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 22 Sep 2021.
- Background: PubMed 29155684Martin JA, Hamilton BE, Osterman MJK. Births in the United States, 2016. NCHS Data Brief. 2017 Sep;(287):1-8.
- Background: PubMed 26278843World Health Organization Human Reproduction Programme, 10 April 2015. WHO Statement on caesarean section rates. Reprod Health Matters. 2015 May;23(45):149-50. doi: 10.1016/j.rhm.2015.07.007. Epub 2015 Jul 27. No abstract available.
- Background: PubMed 21645797Cheng YW, Eden KB, Marshall N, Pereira L, Caughey AB, Guise JM. Delivery after prior cesarean: maternal morbidity and mortality. Clin Perinatol. 2011 Jun;38(2):297-309. doi: 10.1016/j.clp.2011.03.012.
- Background: PubMed 20402716Foureur M, Ryan CL, Nicholl M, Homer C. Inconsistent evidence: analysis of six national guidelines for vaginal birth after cesarean section. Birth. 2010 Mar;37(1):3-10. doi: 10.1111/j.1523-536X.2009.00372.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trial of labor after cesarean section in people with Previous Cesarean Section Scar, run by Mansoura 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 8 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 22 Sep 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?
Novel score (Mosbah) score for evaluation of previous 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 NCT04856254, which also lists 4 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 22 Sep 2021.