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Placenta Accreta / PercretaNCT06761885

Prediction of Placenta Accreta Outcome in Pregnant Woman With Placenta Previa Using (hcg_h ) as Abiomarkers

An observational study of Placenta Accreta / Percreta, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To check if maternal serum (hcg _h ) in second and third trimester in pregnant woman with placenta previa can predict placenta accreta at delivery or predict adverse maternal and neonatal outcome Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Placenta Accreta / Percreta
How many people
74 participants
Where
No sites listed yet
Study dates
Jan 2025to Jul 2025
How long will I take part?
74 Months
Phase
Observational
Are there results?
Not yet: the study is under way

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 45 years
  • Women only
  • Adult

Study population: * pregnant woman * At least previous one CS * Gestational age at second and third trimester * Age (18:45) years

Who may be able to join

  • pregnant woman
  • At least previous one CS
  • Gestational age at second and third trimester
  • Age (18:45) years

Who cannot join

  • proven fetal aneuploidy in current pregnancy

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Esraa Mohammed, Resident contact

01220940533

Esraa.16265998@med.aun.edu.eg

Ahmed Ahmed, Prof.Dr contact

01012588888

Anasr@aun.edu.eg

About this study

Official title: Prediction of Placenta Accreta Outcome in Pregnant Woman With Placenta Previa Using (hcg_h ) as Abiomarker

To check if maternal serum (hcg _h ) in second and third trimester in pregnant woman with placenta previa can predict placenta accreta at delivery or predict adverse maternal and neonatal outcome

Read the detailed description

Placenta accreta was first described in 1937 by Irving et al. as failure of separation of the placenta from the uterine wall following delivery of the human fetus leading to the often used term morbid placental adherence. The condition is characterised by invasive placentation which is associated with catastrophic haemorrhage. Varied terminology has been applied to this condition; however, recent guidelines suggested that placenta accreta spectrum (PAS), which includes accreta, increta, and percreta (defined below), be used going forward.The condition is unique to human pregnancy with no animal correlate reported in the literature.The incidence of PAS has increased substantially from 0.8 per 1000 deliveries in the 1980s to 3 per 1000 deliveries in the past decade, a phenomenon attributed to a rising global caesarean section rate . PAS is associated with significant maternal morbidity and mortality, in particular, major obstetric haemorrhage and peripartum hysterectomy . Mortality rates of up to 7% have been reported to be associated with PAS . The most recent confidential inquiry into maternal mortality in the United Kingdom (MMBRACE-UK, 2017) highlighted the continued high maternal mortality associated with the condition . The most important antenatal risk factor for PAS is the number of previous caesarean sections. In the presence of low-lying placenta (placenta previa) and three previous caesarean sections, a woman would have a 61% risk of PAS. Antenatal diagnosis is a key element to improving maternal and perinatal outcome . Although dedicated ultrasound and MRI having improved antenatal diagnosis, between one half and two thirds of cases remain undiagnosed, resulting in poorer maternal outcomes.For several years, investigators have attempted to identify maternal serum biomarkers that could be used to improve the accuracy of antenatal diagnosis of PAS. The use of ultrasound and MRI in the diagnosis of PAS has been extensively reviewed elsewhere . Several placental and fetal hormones routinely used in the screening for aneuploidy have been found to be differentially expressed in the serum of women with PAS compared with those with placenta previa . HCG is a glycoprotein composed of 244 amino acids with a molecular mass of 36.7 kDa that is produced by the syncytiotrophoblast and maintains pregnancy by stimulating progesterone synthesis by the corpus luteum. A maximum level of approximately 100,000 iu/l is reached by 8-10 weeks of gestation and declines as placental steroid synthesis commences .HCG is a heterodimeric molecule composed of an alpha subunit that is identical to luteinising hormone, follicle-stimulating hormone, and thyroid-stimulating hormone and a beta (β) subunit that is unique. Proteolytic cleavage by trophoblast macrophages destabilises the molecule, thereby producing free β-hCG that is secreted into the maternal circulation . Hyperglycosylated hcg is glycosylation variant of the hormone hcg .its different molecule to regional hcg as it produced by extravillous cytotrophoblastic cell (invasive trophoblast ) its function is invasive promoter as in implantation of pregnancy where it appears to promote cell proliferation ,invasion and implantation

Medical subject headings
Placenta Accreta

What is being measured

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

  1. Prediction of degree of placenta adherence by (hcg_h) and correlation intraoperative finding

    Prediction of degree of placenta adherence by (hcg_h) and correlation intraoperative finding

    Measured: 12months

Timeline

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

  1. First posted7 Jan 2025
  2. Study startJan 2025 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2025 (estimated)

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
Cross-sectional
Enrolment
74 participants (estimated)
Target duration
74 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06761885
Sponsor's protocol ID
placenta accreta & previa
Status last verified
Dec 2024
First submitted
31 Dec 2024
Last updated
7 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Placenta Accreta / Percreta, run by Assiut University.

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 1 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: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Esraa Mohammed, Resident (01220940533, Esraa.16265998@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prediction of degree of placenta adherence by (hcg_h) and correlation intraoperative finding (time frame: 12months). 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 7 Jan 2025.

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