NCT06100640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 30, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

October 16, 2023

Last Update Submit

March 18, 2025

Conditions

Placenta Accreta

Keywords

placenta adherence

Outcome Measures

Primary Outcomes (8)

  • 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

  • calculated amount of blood loss

    the total amount blood lost intraoperatively in millilitres.

    intraoperative and 24 hours postoperative

  • blood transfusion

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

    intraoperative and 24 hours postoperative

  • rate of hysterectomy

    the percentage of cases had hysterectomy in both groups.

    intraoperative till 40 days postoperative

  • internal iliac artery ligation

    the rate of internal iliac artery ligation in both groups.

    intraoperative

  • Intensive care unit admission

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

    postoperative for 5 days

  • hospital stays

    the duration of hospital stays after the operation.

    postoperative for 1 month

  • the presence of intraoperative pouch

    the detection of an intraoperative paracervical pouch grossly.

    intraoperative

Secondary Outcomes (5)

  • total operation time

    intraoperative

  • repair time

    intraoperative

  • preoperative hemoglobin levels in gm/dl

    24 hours before the operation

  • postoperative hemoglobin levels in gm/dl

    6 hours postoperative

  • rate of uterine wall disruption

    intraoperative

Study Arms (2)

positive paracervical pouch

The first group will include patients in whom a paracervical pouch is detected by transvaginal ultrasound.

negative paracervical pouch

the second group will include patients in whom the pouch is not detected by transvaginal ultrasound

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsall patients who can be pregnant
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Patients between 19 to 40 years old
  • Patients had at least one cesarean section.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Alexandria, 21131, Egypt

Location

Related 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.2021.03.018. Epub 2021 Mar 17.

    PMID: 33744177RESULT

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer in obstetrics and gynecology, faculty of medicine

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 25, 2023

Study Start

December 30, 2023

Primary Completion

November 30, 2024

Study Completion

March 10, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations

EG(1)