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Paracervical Pouch in Placenta Accreta Spectrum

Paracervical Pouch Significance in Placenta Accreta Spectrum

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06100640
Acronym
pouch
Enrollment
190
Registered
2023-10-25
Start date
2023-12-30
Completion date
2025-03-10
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Accreta

Keywords

placenta adherence

Brief summary

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

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

Interventions

None listed

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the presence of intraoperative pouchintraoperativethe detection of an intraoperative paracervical pouch grossly.
calculated amount of blood lossintraoperative and 24 hours postoperativethe total amount blood lost intraoperatively in millilitres.
blood transfusionintraoperative and 24 hours postoperativethe amount of packed red blood cell, fresh frozen plasma and platelets transfused in both groups.
rate of hysterectomyintraoperative till 40 days postoperativethe percentage of cases had hysterectomy in both groups.
Intensive care unit admissionpostoperative for 5 daysthe number of patients admitted to the intensive care unit and the duration of their stay.
hospital stayspostoperative for 1 monththe duration of hospital stays after the operation.
internal iliac artery ligationintraoperativethe rate of internal iliac artery ligation in both groups.
the rate of intraoperative diagnosis of placenta accreta spectrumintraoperativethe number of patients diagnosed intraoperatively with placenta accreta spectrum according to international federation of obstetrics and gynecology in both groups.

Secondary

MeasureTime frameDescription
repair timeintraoperativethe duration from the placental separation till closure of the first layer.
preoperative hemoglobin levels in gm/dl24 hours before the operationthe amount of the hemoglobin measured in gm/dl before the operation in both groups.
postoperative hemoglobin levels in gm/dl6 hours postoperativethe amount of the hemoglobin measured in gm/dl after the operation in both groups.
rate of uterine wall disruptionintraoperativethe number of patients who have a disruption of their anterior uterine wall during bladder dissection or placental separation in both groups.
total operation timeintraoperativethe duration from the skin incision till skin closure.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026