Evaluation of Cervical Invasion and Length in Placenta Accreta Patients

NCT07452185 | Not Yet Recruiting

• 1 other identifier: Soh-Med--26-2-3MD
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Placenta Accreta Spectrum; Placenta Accreta; Placenta Previa

Keywords

Placenta accreta spectrum; Cervical invasion; Cervical length; Placenta accreta; Ultrasound evaluation; Preterm labor

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  Immediately prior to delivery

• Hysterectomy rate

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

  Intraoperative

Study Arms (4)

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

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Uterus with placenta in case of hysterectomy

MeSH Terms

Conditions

Placenta Accreta; Placenta Previa; Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Ahmed Salah Ali, MSC

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Salah Salah Ali, Assistant lecturer

CONTACT

+201050199550; ahmedsalahali37@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of OB.&GYN. ,Sohag faculty of medicine

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: March 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share