Paracervical Pouch in Placenta Accreta Spectrum

NCT ID: NCT06100640

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-30

Study Completion Date

2025-03-10

Brief Summary

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The study objective is the significance of the ultrasound detection of the paracervical pouch in placenta accreta spectrum. It aimed to evaluate its relation to the degree of placenta accreta spectrum, amount of the blood loss and the number of packed red blood cells transfused.

Detailed Description

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The study will be carried on patients diagnosed with placenta previa or placenta accreta spectrum and had at least one caesarean section. The study will be divided into 2 groups of 70 patients at least per each. The first group will include patients in whom a paracervical pouch is detected, and the second group will include patients in whom the pouch is not detected by transvaginal ultrasound.

paracervical pouch is defined ultrasonographic as the downward displacement of the uterine serosa from the level of the cervical internal os

Conditions

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Placenta Accreta

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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positive paracervical pouch

The first group will include patients in whom a paracervical pouch is detected by transvaginal ultrasound.

No interventions assigned to this group

negative paracervical pouch

the second group will include patients in whom the pouch is not detected by transvaginal ultrasound

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* • Patients between 19 to 40 years old

* Patients had at least one cesarean section.

Exclusion Criteria

* • Patients who request hysterectomy.

* Patients diagnosed with hepatitis B, C, or HIV,
* Those with bleeding diathesis.
* Patients whose BMI is more than 40 kg/m2.
* Patients who need an emergency cesarean section.
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Omar elshorbagy

lecturer in obstetrics and gynecology, faculty of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Shih JC, Kang J, Tsai SJ, Lee JK, Liu KL, Huang KY. The "rail sign": an ultrasound finding in placenta accreta spectrum indicating deep villous invasion and adverse outcomes. Am J Obstet Gynecol. 2021 Sep;225(3):292.e1-292.e17. doi: 10.1016/j.ajog.2021.03.018. Epub 2021 Mar 17.

Reference Type RESULT
PMID: 33744177 (View on PubMed)

Other Identifiers

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26/564

Identifier Type: -

Identifier Source: org_study_id

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