- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06761885
Prediction of Placenta Accreta Outcome in Pregnant Woman With Placenta Previa Using (hcg_h ) as Abiomarkers
December 31, 2024 updated by: Esraa Mahrous Fouad Mohammed, Assiut University
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
Study Overview
Status
Not yet recruiting
Conditions
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
Study Type
Observational
Enrollment (Estimated)
74
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Esraa Mohammed, Resident
- Phone Number: 01220940533
- Email: Esraa.16265998@med.aun.edu.eg
Study Contact Backup
- Name: Ahmed Ahmed, Prof.Dr
- Phone Number: 01012588888
- Email: Anasr@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
- pregnant woman
- At least previous one CS
- Gestational age at second and third trimester
- Age (18:45) years
Description
Inclusion Criteria:
- pregnant woman
- At least previous one CS
- Gestational age at second and third trimester
- Age (18:45) years
Exclusion Criteria:
- proven fetal aneuploidy in current pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prediction of degree of placenta adherence by (hcg_h) and correlation intraoperative finding
Time Frame: 12months
|
Prediction of degree of placenta adherence by (hcg_h) and correlation intraoperative finding
|
12months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2025
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
December 31, 2024
First Submitted That Met QC Criteria
December 31, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 31, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- placenta accreta & previa
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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