Placenta AccretapouchNCT06100640
Paracervical Pouch in Placenta Accreta Spectrum
An observational study of Placenta Accreta, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Placenta Accreta
- How many people
- 190 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2023to 10 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- • Patients between 19 to 40 years old
- Patients had at least one cesarean section.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paracervical Pouch Significance 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.
Read the 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
- Conditions
- Placenta Accreta
- Keywords
- placenta adherence
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative
calculated amount of blood loss
the total amount blood lost intraoperatively in millilitres.
Measured: intraoperative and 24 hours postoperative
blood transfusion
the amount of packed red blood cell, fresh frozen plasma and platelets transfused in both groups.
Measured: intraoperative and 24 hours postoperative
rate of hysterectomy
the percentage of cases had hysterectomy in both groups.
Measured: intraoperative till 40 days postoperative
internal iliac artery ligation
the rate of internal iliac artery ligation in both groups.
Measured: intraoperative
Intensive care unit admission
the number of patients admitted to the intensive care unit and the duration of their stay.
Measured: postoperative for 5 days
hospital stays
the duration of hospital stays after the operation.
Measured: postoperative for 1 month
the presence of intraoperative pouch
the detection of an intraoperative paracervical pouch grossly.
Measured: intraoperative
Secondary outcomes (5)
total operation time
the duration from the skin incision till skin closure.
Measured: intraoperative
repair time
the duration from the placental separation till closure of the first layer.
Measured: intraoperative
preoperative hemoglobin levels in gm/dl
the amount of the hemoglobin measured in gm/dl before the operation in both groups.
Measured: 24 hours before the operation
postoperative hemoglobin levels in gm/dl
the amount of the hemoglobin measured in gm/dl after the operation in both groups.
Measured: 6 hours postoperative
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.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start30 Dec 2023
- Primary completion30 Nov 2024
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar elshorbagy, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100640
- Sponsor's protocol ID
- 26/564
- Acronym
- pouch
- Status last verified
- Mar 2025
- First submitted
- 16 Oct 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: yes i would like to share the study protocol and the statistical analysis plan
Publications
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.
PubMed 33744177
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracervical Pouch Significance in Placenta Accreta Spectrum
- ClinicalTrials.gov ID
- NCT06100640
- Acronym / sponsor ID
- pouch / 26/564
- Conditions
- Placenta Accreta
- Keywords
- placenta adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- • Patients between 19 to 40 years old
Key exclusion criteria (5 listed)
- • Patients who request hysterectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
calculated amount of blood loss
Time frame: intraoperative and 24 hours postoperative
the total amount blood lost intraoperatively in millilitres.
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.
rate of hysterectomy
Time frame: intraoperative till 40 days postoperative
the percentage of cases had hysterectomy in both groups.
internal iliac artery ligation
Time frame: intraoperative
the rate of internal iliac artery ligation in both groups.
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.
hospital stays
Time frame: postoperative for 1 month
the duration of hospital stays after the operation.
the presence of intraoperative pouch
Time frame: intraoperative
the detection of an intraoperative paracervical pouch grossly.
5 secondary outcomes
total operation time
Time frame: intraoperative
repair time
Time frame: intraoperative
preoperative hemoglobin levels in gm/dl
Time frame: 24 hours before the operation
postoperative hemoglobin levels in gm/dl
Time frame: 6 hours postoperative
rate of uterine wall disruption
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Results publication: PubMed 33744177Shih 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.
- Individual participant dataSharing planned: Undecided. yes i would like to share the study protocol and the statistical analysis plan
Related trials for Placenta Accreta
Not yet recruitingObservational study
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
Placenta Accreta, Third Trimester
Not yet recruitingObservational study
Total Lower Uterine Segmentectomy With Adjunctive Mechanical Towel Compression for the Surgical Management of Placenta Accreta Spectrum Disorders
Placenta Accreta Management
Recruiting
Comparison Between 3 Conservative Surgeries for Placenta Accreta Spectrum
Placenta Accreta Spectrum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of intraoperative diagnosis of placenta accreta spectrum (time frame: intraoperative). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06100640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.