Placenta Accreta SpectrumNCT07452185
Evaluation of Cervical Invasion and Length in Placenta Accreta Patients
An observational study of Placenta Accreta Spectrum and Placenta Accreta, run by Sohag University.
Trial summary
Placenta accreta spectrum (PAS), also called morbidly adherent placenta, is a serious pregnancy problem where the placenta attaches too deeply to the uterus wall and does not come out normally after birth. This often happens after previous cesarean sections or when the placenta is low (placenta previa). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Placenta Accreta Spectrum, Placenta Accreta, Placenta Previa
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Jan 2028
- How long will I take part?
- 16 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Screen high-risk pregnant women presenting at 18:32 weeks' gestation via history and initial transabdominal ultrasound for PAS risk factors (e.g., placenta previa, prior cesarean). -Obtain informed consent and perform baseline laboratory tests (e.g., complete blood count, coagulation profile). -Ultrasonographic Evaluation for Cervical Invasion: *Perform transvaginal ultrasound (TVUS) using a high-frequency probe (e.g., 5-9 MHz) in a standardized manner, ensuring patient comfort and safety (e.g., empty bladder, lithotomy position). *Assess for standard PAS markers first: loss of retroplacental clear zone, myometrial thinning <1 mm, placental lacunae (Swiss cheese appearance), abnormal utero-placental hypervascularity, bridging vessels, and placental bulge .
Who may be able to join
- Pregnant women aged 18-45 years with suspected or confirmed PAS based on prenatal ultrasound (e.g., placenta previa with at least one prior cesarean section).
- Gestational age between 18-32 weeks at enrollment to allow for serial monitoring.
- Singleton pregnancy.
- High-risk features such as history of multiple cesarean sections, antepartum bleeding, or abnormal placental location on initial screening.
Who cannot join
- Multiple gestation.
- Pre-existing cervical incompetence or cerclage placement prior to enrollment. -Transfer from outside facilities without complete prenatal records.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Placental Cervical Invasion and Cervical Length in Patients With Placenta Accreta
Placenta accreta spectrum (PAS), also called morbidly adherent placenta, is a serious pregnancy problem where the placenta attaches too deeply to the uterus wall and does not come out normally after birth. This often happens after previous cesarean sections or when the placenta is low (placenta previa). It can cause heavy bleeding, serious complications, and danger to the mother.
This study will look at pregnant women with PAS at Sohag University Hospital in Egypt. Researchers will use ultrasound to check two things:
Read more
How much the placenta has invaded the cervix (the lower part of the uterus). The length of the cervix.
The main goals are to find out:
How common cervical invasion is in PAS cases. What happens to women who have this invasion (outcomes like bleeding or surgery needs).
If a short cervix is linked to early labor (preterm birth). Women with confirmed PAS will join this observational study from March 2026 to January 2028. They will have extra ultrasound scans during pregnancy. No new treatments or drugs are tested - the study only collects information from routine care and scans to better understand the condition.
This research may help doctors predict risks earlier, plan safer deliveries, and improve care for mothers and babies with PAS in the future.
Read the detailed description
Placenta accreta spectrum (PAS), previously termed morbidly adherent placenta, includes a spectrum of disorders characterized by abnormal adherence of placental tissue to or invasion into the myometrium, frequently associated with prior cesarean deliveries and placenta previa. The rising incidence of PAS correlates with increasing cesarean section rates worldwide, posing substantial risks such as massive postpartum hemorrhage, surgical complications, organ injury (e.g., bladder), and maternal mortality.
Cervical invasion in PAS involves extension of placental tissue into the cervical stroma or cervico-isthmic complex, potentially leading to fibrosis in the lower posterior cervical-trigonal space. This feature complicates surgical management and heightens risks of uncontrollable bleeding and adjacent organ damage. Although cervical involvement has been underrecognized as a distinct entity in many prior studies, emerging evidence links fibrosis-associated cervico-trigonal invasion to severe morbidity.
Additionally, cervical length (CL) assessment in PAS patients has shown that a short CL (≤30 mm) is associated with increased risk of massive intraoperative hemorrhage. Retrospective data suggest CL as a predictor of unscheduled deliveries and preterm birth in this population.
The current study introduces a novel multidisciplinary protocol integrating prospective evaluation of placental cervical invasion (via ultrasound) and cervical length measurement in PAS patients. This combined approach aims to provide a unified framework for enhanced risk stratification, better anticipation of complications, and optimization of surgical planning to minimize unscheduled interventions and improve maternal and neonatal outcomes.
Aim of the study To estimate the incidence of cervical invasion in placenta accreta spectrum patients, assess outcomes in those cases, evaluate cervical length in PAS patients, and investigate its relation to preterm labor.
Patients and Methods This is a prospective observational (conservative) study enrolling women diagnosed with placenta accreta spectrum. Recruitment will occur from March 2026 to January 2028 at Sohag University Hospital, a tertiary referral center in Sohag Governorate, Egypt. The hospital features advanced obstetric imaging capabilities, multidisciplinary teams including maternal-fetal medicine specialists, and neonatal intensive care support for high-risk pregnancies.
Eligible participants are pregnant women with confirmed PAS (based on prenatal ultrasound/MRI criteria). Study procedures involve serial transvaginal and transabdominal ultrasound assessments to measure cervical length and evaluate the extent of placental cervical invasion. Data will include demographic details, obstetric history, imaging findings, delivery mode, intraoperative complications, blood loss, and maternal/neonatal outcomes. No interventional treatments are introduced; management follows standard institutional protocols for PAS.
- Conditions
- Placenta Accreta Spectrum, Placenta Accreta, Placenta Previa
- Keywords
- Placenta accreta spectrum, Cervical invasion, Cervical length, Placenta accreta, Ultrasound evaluation, Preterm labor
- Medical subject headings
- Placenta Accreta, Placenta Previa, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PAS patients with cervical invasion | Have cervical invasion using criteria compiled from multiple studies: ٭Extension of placental tissue into the cervical stroma or cervico-isthmic complex (CIC), with placental tissue encroaching on or beyond the internal os without clear separation . ٭Irregular cervical contour or disruption of the normal cervical architecture, including fibrosis in the lower posterior cervical-trigonal space (associated with type 4 PAS and higher morbidity) . ٭Increased vascularity within the cervical canal or stroma, detected via color Doppler showing turbulent flow or lacunae extending into the cervix (predictive of deep invasion and bleeding risk) . ٭Presence of intracervical lakes (novel marker: hypoechoic or anechoic spaces within the cervical tissue, suggestive of invasive placentation) . | |
| PAS patients without cervical invasion | Haven't cervical invasion using criteria compiled from multiple studies: ٭Extension of placental tissue into the cervical stroma or cervico-isthmic complex (CIC), with placental tissue encroaching on or beyond the internal os without clear separation . ٭Irregular cervical contour or disruption of the normal cervical architecture, including fibrosis in the lower posterior cervical-trigonal space (associated with type 4 PAS and higher morbidity) . ٭Increased vascularity within the cervical canal or stroma, detected via color Doppler showing turbulent flow or lacunae extending into the cervix (predictive of deep invasion and bleeding risk) . ٭Presence of intracervical lakes (novel marker: hypoechoic or anechoic spaces within the cervical tissue, suggestive of invasive placentation) . Scoring systems integration: | |
| PAS patients with short cervical length | Cervical length will be measured in admission and before delivery The final CL measurement prior to delivery was analyzed. Unscheduled delivery was defined as urgent delivery prior to the scheduled date due to either bleeding or preterm contractions. A receiver operating characteristics (ROC) curve was created, the optimal CL associated with unscheduled delivery was selected, and associations and prediction analyses were performed. Short cl < 3 cm | |
| PAS patients with normal cervical length | Cervical length will be measured in admission and before delivery The final CL measurement prior to delivery was analyzed. Unscheduled delivery was defined as urgent delivery prior to the scheduled date due to either bleeding or preterm contractions. A receiver operating characteristics (ROC) curve was created, the optimal CL associated with unscheduled delivery was selected, and associations and prediction analyses were performed. Short cl ≥ 3 cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative findings regarding cervical invasion of placenta .
Visible placental tissue extending into or through the lower uterine segment and cervix, sometimes protruding into the cervical canal or os.
Bluish/purple discoloration or bulging/distension ("bulge sign") of the lower uterine segment and cervical area due to underlying placental invasion.
Prominent hypervascularity: Dense, tangled vessels (often large, tortuous, or engorged) running over the serosal surface of the lower uterus and cervix; this includes abnormal neovascularization or "rail sign"-like patterns.
Adherent placenta that does not separate easily; attempts at gentle cord traction may show the "dimple sign" (uterus pulled inward without placental release).
Thinned or disrupted myometrium in the lower segment/cervix, with placental villi directly attached or invading deeply (no clear cleavage plane).
In more severe (percreta-like) cases involving the cervix:
Placental protrusion or exophytic growth through the serosa. and confirmed by histopathology
Measured: Intraoperative
timing of delivery
Gestational age in weeks and days at the time of delivery (calculated from last menstrual period or early ultrasound dating) to note the preterm labour and its association with cervical length
Measured: At delivery
Cervical length before delivery
Cervical length will be measured immediately before delivery by ultrasound to estimate relation between short cervical length and preterm labor
Measured: Immediately prior to delivery
Hysterectomy rate
Number of CS hysterectomy done for the patients of placenta accreta spectrum with cervical invasion
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta SpectrumStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 16 Weeks
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salah Ali, Sohag University
- Investigators
- Ahmed Salah Ali, MSC, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452185
- Sponsor's protocol ID
- Soh-Med--26-2-3MD
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Placental Cervical Invasion and Cervical Length in Patients With Placenta Accreta
- ClinicalTrials.gov ID
- NCT07452185
- Acronym / sponsor ID
- Soh-Med--26-2-3MD
- Conditions
- Placenta Accreta Spectrum, Placenta Accreta, Placenta Previa
- Keywords
- Placenta accreta spectrum, Cervical invasion, Cervical length, Placenta accreta, Ultrasound evaluation, Preterm labor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 5 Mar 2026 (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.
Placenta accreta spectrum (PAS), also called morbidly adherent placenta, is a serious pregnancy problem where the placenta attaches too deeply to the uterus wall and does not come out normally after birth. This often happens after previous cesarean sections or when the placenta is low (placenta previa). It can cause heavy bleeding, serious complications, and danger to the mother.
This study will look at pregnant women with PAS at Sohag University Hospital in Egypt. Researchers will use ultrasound to check two things:
How much the placenta has invaded the cervix (the lower part of the uterus). The length of the cervix.
The main goals are to find out:
How common cervical invasion is in PAS cases. What happens to women who have this invasion (outcomes like bleeding or surgery needs).
If a short cervix is linked to early labor (preterm birth). Women with confirmed PAS will join this observational study from March 2026 to January 2028. They will have extra ultrasound scans during pregnancy. No new treatments or drugs are tested - the study only collects information from routine care and scans to better understand the condition.
This research may help doctors predict risks earlier, plan safer deliveries, and improve care for mothers and babies with PAS in the future.
Detailed description
Placenta accreta spectrum (PAS), previously termed morbidly adherent placenta, includes a spectrum of disorders characterized by abnormal adherence of placental tissue to or invasion into the myometrium, frequently associated with prior cesarean deliveries and placenta previa. The rising incidence of PAS correlates with increasing cesarean section rates worldwide, posing substantial risks such as massive postpartum hemorrhage, surgical complications, organ injury (e.g., bladder), and maternal mortality.
Cervical invasion in PAS involves extension of placental tissue into the cervical stroma or cervico-isthmic complex, potentially leading to fibrosis in the lower posterior cervical-trigonal space. This feature complicates surgical management and heightens risks of uncontrollable bleeding and adjacent organ damage. Although cervical involvement has been underrecognized as a distinct entity in many prior studies, emerging evidence links fibrosis-associated cervico-trigonal invasion to severe morbidity.
Additionally, cervical length (CL) assessment in PAS patients has shown that a short CL (≤30 mm) is associated with increased risk of massive intraoperative hemorrhage. Retrospective data suggest CL as a predictor of unscheduled deliveries and preterm birth in this population.
The current study introduces a novel multidisciplinary protocol integrating prospective evaluation of placental cervical invasion (via ultrasound) and cervical length measurement in PAS patients. This combined approach aims to provide a unified framework for enhanced risk stratification, better anticipation of complications, and optimization of surgical planning to minimize unscheduled interventions and improve maternal and neonatal outcomes.
Aim of the study To estimate the incidence of cervical invasion in placenta accreta spectrum patients, assess outcomes in those cases, evaluate cervical length in PAS patients, and investigate its relation to preterm labor.
Patients and Methods This is a prospective observational (conservative) study enrolling women diagnosed with placenta accreta spectrum. Recruitment will occur from March 2026 to January 2028 at Sohag University Hospital, a tertiary referral center in Sohag Governorate, Egypt. The hospital features advanced obstetric imaging capabilities, multidisciplinary teams including maternal-fetal medicine specialists, and neonatal intensive care support for high-risk pregnancies.
Eligible participants are pregnant women with confirmed PAS (based on prenatal ultrasound/MRI criteria). Study procedures involve serial transvaginal and transabdominal ultrasound assessments to measure cervical length and evaluate the extent of placental cervical invasion. Data will include demographic details, obstetric history, imaging findings, delivery mode, intraoperative complications, blood loss, and maternal/neonatal outcomes. No interventional treatments are introduced; management follows standard institutional protocols for PAS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 16 Weeks
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PAS patients with cervical invasion | – | –Have cervical invasion using criteria compiled from multiple studies: ٭Extension of placental tissue into the cervical stroma or cervico-isthmic complex (CIC), with placental tissue encroaching on or beyond the internal os without clear separation . ٭Irregular cervical contour or disruption of the normal cervical architecture, including fibrosis in the lower posterior cervical-trigonal space (associated with type 4 PAS and higher morbidity) . ٭Increased vascularity within the cervical canal or stroma, detected via color Doppler showing turbulent flow or lacunae extending into the cervix (predictive of deep invasion and bleeding risk) . ٭Presence of intracervical lakes (novel marker: hypoechoic or anechoic spaces within the cervical tissue, suggestive of invasive placentation) . |
| PAS patients without cervical invasion | – | –Haven't cervical invasion using criteria compiled from multiple studies: ٭Extension of placental tissue into the cervical stroma or cervico-isthmic complex (CIC), with placental tissue encroaching on or beyond the internal os without clear separation . ٭Irregular cervical contour or disruption of the normal cervical architecture, including fibrosis in the lower posterior cervical-trigonal space (associated with type 4 PAS and higher morbidity) . ٭Increased vascularity within the cervical canal or stroma, detected via color Doppler showing turbulent flow or lacunae extending into the cervix (predictive of deep invasion and bleeding risk) . ٭Presence of intracervical lakes (novel marker: hypoechoic or anechoic spaces within the cervical tissue, suggestive of invasive placentation) . Scoring systems integration: |
| PAS patients with short cervical length | – | –Cervical length will be measured in admission and before delivery The final CL measurement prior to delivery was analyzed. Unscheduled delivery was defined as urgent delivery prior to the scheduled date due to either bleeding or preterm contractions. A receiver operating characteristics (ROC) curve was created, the optimal CL associated with unscheduled delivery was selected, and associations and prediction analyses were performed. Short cl < 3 cm |
| PAS patients with normal cervical length | – | –Cervical length will be measured in admission and before delivery The final CL measurement prior to delivery was analyzed. Unscheduled delivery was defined as urgent delivery prior to the scheduled date due to either bleeding or preterm contractions. A receiver operating characteristics (ROC) curve was created, the optimal CL associated with unscheduled delivery was selected, and associations and prediction analyses were performed. Short cl ≥ 3 cm |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Screen high-risk pregnant women presenting at 18:32 weeks' gestation via history and initial transabdominal ultrasound for PAS risk factors (e.g., placenta previa, prior cesarean). -Obtain informed consent and perform baseline laboratory tests (e.g., complete blood count, coagulation profile). -Ultrasonographic Evaluation for Cervical Invasion: *Perform transvaginal ultrasound (TVUS) using a high-frequency probe (e.g., 5-9 MHz) in a standardized manner, ensuring patient comfort and safety (e.g., empty bladder, lithotomy position). *Assess for standard PAS markers first: loss of retroplacental clear zone, myometrial thinning <1 mm, placental lacunae (Swiss cheese appearance), abnormal utero-placental hypervascularity, bridging vessels, and placental bulge .
Key inclusion criteria (4 listed)
- Pregnant women aged 18-45 years with suspected or confirmed PAS based on prenatal ultrasound (e.g., placenta previa with at least one prior cesarean section).
- Gestational age between 18-32 weeks at enrollment to allow for serial monitoring.
- Singleton pregnancy.
- High-risk features such as history of multiple cesarean sections, antepartum bleeding, or abnormal placental location on initial screening.
Key exclusion criteria (2 listed)
- Multiple gestation.
- Pre-existing cervical incompetence or cerclage placement prior to enrollment. -Transfer from outside facilities without complete prenatal records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative findings regarding cervical invasion of placenta .
Time frame: Intraoperative
Visible placental tissue extending into or through the lower uterine segment and cervix, sometimes protruding into the cervical canal or os. Bluish/purple discoloration or bulging/distension ("bulge sign") of the lower uterine segment and cervical area due to underlying placental invasion. Prominent hypervascularity: Dense, tangled vessels (often large, tortuous, or engorged) running over the serosal surface of the lower uterus and cervix; this includes abnormal neovascularization or "rail sign"-like patterns. Adherent placenta that does not separate easily; attempts at gentle cord traction may show the "dimple sign" (uterus pulled inward without placental release). Thinned or disrupted myometrium in the lower segment/cervix, with placental villi directly attached or invading deeply (no clear cleavage plane). In more severe (percreta-like) cases involving the cervix: Placental protrusion or exophytic growth through the serosa. and confirmed by histopathology
timing of delivery
Time frame: At delivery
Gestational age in weeks and days at the time of delivery (calculated from last menstrual period or early ultrasound dating) to note the preterm labour and its association with cervical length
Cervical length before delivery
Time frame: Immediately prior to delivery
Cervical length will be measured immediately before delivery by ultrasound to estimate relation between short cervical length and preterm labor
Hysterectomy rate
Time frame: Intraoperative
Number of CS hysterectomy done for the patients of placenta accreta spectrum with cervical invasion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Placenta Accreta Spectrum
Not yet recruitingObservational study
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
Placenta Accreta, Third Trimester
Not yet recruitingObservational study
Total Lower Uterine Segmentectomy With Adjunctive Mechanical Towel Compression for the Surgical Management of Placenta Accreta Spectrum Disorders
Placenta Accreta Management
Recruiting
Comparison Between 3 Conservative Surgeries for Placenta Accreta Spectrum
Placenta Accreta Spectrum
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.
Ahmed Salah Ali, MSC principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta Spectrum and Placenta Accreta, run by Sohag University.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Salah Salah Ali, Assistant lecturer (+201050199550, ahmedsalahali37@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative findings regarding cervical invasion of placenta . (time frame: Intraoperative). The study lists 4 primary outcomes in all. 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 5 Mar 2026.