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NCT Number: NCT06100640

Paracervical Pouch in Placenta Accreta Spectrum

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.

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Key information

Conditions

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

Age range

19 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Medicine

Alexandria, 21131, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. the rate of intraoperative diagnosis of placenta accreta spectrum

    Time frame: intraoperative

    the number of patients diagnosed intraoperatively with placenta accreta spectrum according to international federation of obstetrics and gynecology in both groups.

  2. calculated amount of blood loss

    Time frame: intraoperative and 24 hours postoperative

    the total amount blood lost intraoperatively in millilitres.

  3. blood transfusion

    Time frame: intraoperative and 24 hours postoperative

    the amount of packed red blood cell, fresh frozen plasma and platelets transfused in both groups.

  4. rate of hysterectomy

    Time frame: intraoperative till 40 days postoperative

    the percentage of cases had hysterectomy in both groups.

  5. internal iliac artery ligation

    Time frame: intraoperative

    the rate of internal iliac artery ligation in both groups.

  6. Intensive care unit admission

    Time frame: postoperative for 5 days

    the number of patients admitted to the intensive care unit and the duration of their stay.

  7. hospital stays

    Time frame: postoperative for 1 month

    the duration of hospital stays after the operation.

  8. the presence of intraoperative pouch

    Time frame: intraoperative

    the detection of an intraoperative paracervical pouch grossly.

Secondary outcomes

  1. total operation time

    Time frame: intraoperative

    the duration from the skin incision till skin closure.

  2. repair time

    Time frame: intraoperative

    the duration from the placental separation till closure of the first layer.

  3. preoperative hemoglobin levels in gm/dl

    Time frame: 24 hours before the operation

    the amount of the hemoglobin measured in gm/dl before the operation in both groups.

  4. postoperative hemoglobin levels in gm/dl

    Time frame: 6 hours postoperative

    the amount of the hemoglobin measured in gm/dl after the operation in both groups.

  5. rate of uterine wall disruption

    Time frame: intraoperative

    the number of patients who have a disruption of their anterior uterine wall during bladder dissection or placental separation in both groups.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Paracervical Pouch Significance in Placenta Accreta Spectrum

Acronym: pouch

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 25, 2023
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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