Paracervical Pouch in Placenta Accreta Spectrum

Placenta Accreta Clinical Trial

— pouch  

Official title:

Paracervical Pouch Significance in Placenta Accreta Spectrum

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06100640
• Other study ID #: 26/564
• Status: Not yet recruiting
• Start date: October 30, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2023
• Source: Alexandria University
• Contact: Omar yousry Elshorbagy, PhD
• Phone: +201111362322
• Email: oyke2011[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Accreta

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of intraoperative diagnosis of placenta accreta spectrum	the number of patients diagnosed intraoperatively with placenta accreta spectrum according to international federation of obstetrics and gynecology in both groups.	intraoperative
Primary	calculated amount of blood loss	the total amount blood lost intraoperatively in millilitres.	intraoperative and 24 hours postoperative
Primary	blood transfusion	the amount of packed red blood cell, fresh frozen plasma and platelets transfused in both groups.	intraoperative and 24 hours postoperative
Primary	rate of hysterectomy	the percentage of cases had hysterectomy in both groups.	intraoperative till 40 days postoperative
Primary	internal iliac artery ligation	the rate of internal iliac artery ligation in both groups.	intraoperative
Primary	Intensive care unit admission	the number of patients admitted to the intensive care unit and the duration of their stay.	postoperative for 5 days
Primary	hospital stays	the duration of hospital stays after the operation.	postoperative for 1 month
Primary	the presence of intraoperative pouch	the detection of an intraoperative paracervical pouch grossly.	intraoperative
Secondary	total operation time	the duration from the skin incision till skin closure.	intraoperative
Secondary	repair time	the duration from the placental separation till closure of the first layer.	intraoperative
Secondary	preoperative hemoglobin levels in gm/dl	the amount of the hemoglobin measured in gm/dl before the operation in both groups.	24 hours before the operation
Secondary	postoperative hemoglobin levels in gm/dl	the amount of the hemoglobin measured in gm/dl after the operation in both groups.	6 hours postoperative
Secondary	rate of uterine wall disruption	the number of patients who have a disruption of their anterior uterine wall during bladder dissection or placental separation in both groups.	intraoperative