Paracervical Pouch in Placenta Accreta Spectrum

Completed

• Conditions: Placenta Accreta

• Registration Number: NCT06100640
• Lead Sponsor: Alexandria University

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

Study Timeline

• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-20
• Study First Posted: 2023-10-25
• Study Start: 2023-12-30
• Primary Completion: 2024-11-30
• Status Verified: 2025-03
• Study Completion: 2025-03-10
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 190

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
internal iliac artery ligation	intraoperative	the rate of internal iliac artery ligation in both groups.
blood transfusion	intraoperative and 24 hours postoperative	the amount of packed red blood cell, fresh frozen plasma and platelets transfused in both groups.
Intensive care unit admission	postoperative for 5 days	the number of patients admitted to the intensive care unit and the duration of their stay.
hospital stays	postoperative for 1 month	the duration of hospital stays after the operation.
the rate of intraoperative diagnosis of placenta accreta spectrum	intraoperative	the number of patients diagnosed intraoperatively with placenta accreta spectrum according to international federation of obstetrics and gynecology in both groups.
calculated amount of blood loss	intraoperative and 24 hours postoperative	the total amount blood lost intraoperatively in millilitres.
the presence of intraoperative pouch	intraoperative	the detection of an intraoperative paracervical pouch grossly.
rate of hysterectomy	intraoperative till 40 days postoperative	the percentage of cases had hysterectomy in both groups.

Secondary Outcome Measures

Name	Time	Method
preoperative hemoglobin levels in gm/dl	24 hours before the operation	the amount of the hemoglobin measured in gm/dl before the operation in both groups.
total operation time	intraoperative	the duration from the skin incision till skin closure.
rate of uterine wall disruption	intraoperative	the number of patients who have a disruption of their anterior uterine wall during bladder dissection or placental separation in both groups.
postoperative hemoglobin levels in gm/dl	6 hours postoperative	the amount of the hemoglobin measured in gm/dl after the operation in both groups.
repair time	intraoperative	the duration from the placental separation till closure of the first layer.

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt