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Not yet recruitingNCT07452185Updated Mar 5, 2026

Evaluation of Cervical Invasion and Length in Placenta Accreta Patients

An observational study in Placenta Accreta Spectrum, Placenta Accreta and Placenta Previa, sponsored by Sohag University. Not yet recruiting. Open to female participants. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Sex
Female
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Study 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). 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.

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.

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Conditions studied

  • Placenta Accreta Spectrum
  • Placenta Accreta
  • Placenta Previa

Keywords

  • Placenta accreta spectrum
  • Cervical invasion
  • Cervical length
  • Placenta accreta
  • Ultrasound evaluation
  • Preterm labor
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In context

Placenta Accreta

150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.

This study's planned enrollment of 200 is above the median of 87 across 78 observational studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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 .

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Multiple gestation.
  • Pre-existing cervical incompetence or cerclage placement prior to enrollment. -Transfer from outside facilities without complete prenatal records.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
16 Weeks
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Intraoperative

  2. 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

    Time frame: At delivery

  3. Cervical length before delivery

    Cervical length will be measured immediately before delivery by ultrasound to estimate relation between short cervical length and preterm labor

    Time frame: Immediately prior to delivery

  4. Hysterectomy rate

    Number of CS hysterectomy done for the patients of placenta accreta spectrum with cervical invasion

    Time frame: Intraoperative

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2026; primary completion for Jan 2028, 22 months later.

Of 34 observational studies under Placenta Accreta, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 22 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2026
First posted
Mar 5, 2026
StartEst.
Mar 1, 2026
Primary completionEst.
Jan 1, 2028
CompletionEst.
Jan 1, 2028
Last update
Mar 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07452185
Lead sponsor
Sohag University
Responsible party
Ahmed Salah Ali (Assistant lecturer of OB.&GYN. ,Sohag faculty of medicine, Sohag University) — Principal investigator
First posted
Mar 5, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Mar 5, 2026

Study contacts

Ahmed Salah Salah Ali, Assistant lecturer
Contact
ahmedsalahali37@yahoo.com
+201050199550
Ahmed Salah Ali, MSC
principal investigator · Sohag University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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