AzTrials
AzTrials

Placenta PreviaNCT06220760

Outcomes of Placenta Accreta Spectrum Disorders Surgery in Relation to Placenta Accreta Scoring Index

An observational study of Placenta Previa and Placenta Accreta, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Using of Ultra sound in assessment of Placenta Accreta Index to predict the surgical outcomes of Placenta accreta Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Placenta Previa, Placenta Accreta
What is being tested?
Ultrasound
How many people
154 participants
Where
1 siteEgypt
Study dates
20 Feb 2024to 30 Sep 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 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Women with Previous Scar of cesarean section who are 32weeks of gestation or more who are known to be Placenta previa

Who may be able to join

  • pregnant women with gestational age 32 weeks or more
  • singleton pregnancy
  • known to have placenta previa (lower edge of the placenta within 5 cm from internal Os )
  • with at least previous 1 cesarean section

Who cannot join

  • the patient is active in labor
  • haemodynamically unstable

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Assiut University

    Asyut, Asyut Governorate, 71515

Other trials in Egypt

About this study

Using of Ultra sound in assessment of Placenta Accreta Index to predict the surgical outcomes of Placenta accreta

Read the detailed description

Placenta accreta is a substantially life-threatening condition and one of the causes of maternal morbidity and mortality in the world. According to study done in United Kingdom, The estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities overall and 577 per 10,000 in women with both a previous caesarean delivery and placenta previa [1]. in a tertiary south Italian center, The incidence increased from 0.12% during the 1970s, to 0.31% during the 2000s [2].While in USA, the prevalence of placenta accreta was 3.7 per 1000 deliveries [3].

This increase is due to many factors. A scar of previous uterine surgery is a major risk factor for placenta accreta. Caesarean section scar is the most common one of uterine scars according to [4] especially in presence of placenta previa where the risk of placenta accreta was 3%, 11%, 40%, 61%, and 67% for the first, second, third, fourth, and fifth or greater repeat cesarean deliveries, respectively. [5] reported that both cesarean delivery morbidity and placenta accreta were positively associated with age >30 years. Previous myomectomy, multi parity, vigorous curettage are other risk factors as said [6]. More ever sub mucous leiomyoma and thermal ablation are also contributing factors to Placenta accreta [7] and lastly [8] said that uterine artery embolization is considered as a risk factor for occurrence of placenta accreta. Contrarily, inter pregnancy interval more than 60 months was associated with decreased risk of placenta accreta [9].

Because placenta accreta can lead to life-threatening blood loss, identification of these high-risk patients would be helpful in management of the pregnancy in addition to enabling the surgeon to be prepared adequately before the time of delivery. Many studies have been done on identification of placenta accreta in the third trimester by 2D ultrasound and color Doppler. There are many modalities for detection of placenta accreta ante natally [10] used 2D ultrasound and color doppler for detection of placenta accreta in 3rd trimester with sensitivity and specificity; 95.24% and 94.74% respectively for ultrasound with the most prominent feature presence of multiple lakes that represented dilated vessels extending from the placenta through the myometrium. For Doppler, the most prominent feature was the presence of interphase hypervascularity with abnormal vessels linking the placenta to the bladder, and the rate was 95.24%.

As for surgery for placenta accreta, planned caesarean hysterectomy is recommended to reduce mortality and morbidity, but fertility is lost. Antenatal diagnosis of placenta accreta spectrum (PAS) can ensure multidisciplinary management at center of excellence which can reduce maternal and fetal complications. This can be established by a scoring system which provides a standardized criterion for the diagnosis and management Placenta Accreta Index (PAI).

Instead of adhering to the conventional approach that involves an elective caesarean hysterectomy based on antenatal imaging, more suitable approaches should be considered from the spectrum of hemostatic and fertility-preserving options available. In our study we will investigate if the degree of adherence is related to the PAI score. Therefore, we can predict cases which will need conservative surgery or peripartum hysterectomy. And so that the surgeon be preplanned to do either hysterectomy or conservative surgery

Being tested
Ultrasound
Medical subject headings
Placenta Previa, Placenta Accreta

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundDiagnostic test

    The use of US to calculate placenta accreta index

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. to decide If placenta accreta index (PAI) can predict suitable type of operation needed whether Conservative management/fertility-sparing techniques or Caesarean hysterectomy

    Measured: 23 months

Secondary outcomes (3)
  1. Incidence of fetal complication associated with placenta accreta

    Measured: 23 months

  2. Incidence of maternal complications associated with placenta accreta

    Measured: 23 months

  3. The need for ICU admission after placenta accreta surgery and its duration

    Measured: 23 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2024
  2. Study start20 Feb 2024
  3. Primary completion30 Dec 2024
  4. Study completion30 Sep 2025

Resources

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
Prospective
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06220760
Sponsor's protocol ID
US in Placenta accreta
Status last verified
Nov 2025
First submitted
14 Jan 2024
Last updated
21 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Placenta Previa and Placenta Accreta, run by Assiut 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 4 inclusion and 2 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 21 Nov 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?

to decide If placenta accreta index (PAI) can predict suitable type of operation needed whether Conservative management/fertility-sparing techniques or Caesarean hysterectomy (time frame: 23 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Nov 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in