Clinical trial NCT06100640: Paracervical Pouch in Placenta Accreta Spectrum
Official title: Paracervical Pouch Significance in Placenta Accreta Spectrum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Accreta
Keywords: placenta adherence
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 190
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be carried out on pregnant patients diagnosed with placenta previa or placenta accreta spectrum and who had at least one cesarean 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: the rate of intraoperative diagnosis of placenta accreta spectrum
timeFrame: intraoperative
measure: calculated amount of blood loss
timeFrame: intraoperative and 24 hours postoperative
measure: blood transfusion
timeFrame: intraoperative and 24 hours postoperative
measure: rate of hysterectomy
timeFrame: intraoperative till 40 days postoperative
measure: internal iliac artery ligation
timeFrame: intraoperative
measure: Intensive care unit admission
timeFrame: postoperative for 5 days
measure: hospital stays
timeFrame: postoperative for 1 month
measure: the presence of intraoperative pouch
timeFrame: intraoperative
Secondary outcomes:
measure: total operation time
timeFrame: intraoperative
measure: repair time
timeFrame: intraoperative
measure: preoperative hemoglobin levels in gm/dl
timeFrame: 24 hours before the operation
measure: postoperative hemoglobin levels in gm/dl
timeFrame: 6 hours postoperative
measure: rate of uterine wall disruption
timeFrame: intraoperative
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
citation: 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.