Evaluation of Cervical Invasion and Length in Placenta Accreta Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorSohag University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Multiple gestation.
Pre-existing cervical incompetence or cerclage placement prior to enrollment. -Transfer from outside facilities without complete prenatal records.
Trial 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 .
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 4 trial groupsGroup A: PAS patients with cervical invasion
Group B: PAS patients without cervical invasion
Group C: PAS patients with short cervical length
Group D: PAS patients with normal cervical length
Trial outcomes
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
Intraoperative2
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 delivery3
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 delivery4
Hysterectomy rate
Number of CS hysterectomy done for the patients of placenta accreta spectrum with cervical invasion
Time frame
IntraoperativeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: