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.
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.
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
- Conditions
- Placenta Accreta / Percreta
- Medical subject headings
- Placenta Accreta
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted7 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta / PercretaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 74 participants (estimated)
- Target duration
- 74 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mahrous Fouad Mohammed, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Placenta Accreta Outcome in Pregnant Woman With Placenta Previa Using (hcg_h ) as Abiomarker
- ClinicalTrials.gov ID
- NCT06761885
- Acronym / sponsor ID
- placenta accreta & previa
- Conditions
- Placenta Accreta / Percreta
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 7 Jan 2025 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 74 Months
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- * pregnant woman * At least previous one CS * Gestational age at second and third trimester * Age (18:45) years
Key inclusion criteria (4 listed)
- pregnant woman
- At least previous one CS
- Gestational age at second and third trimester
- Age (18:45) years
Key exclusion criteria (1 listed)
- proven fetal aneuploidy in current pregnancy
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- 1- Irving C. And Hertig A. T., A study of placenta accreta, Surgery, Gynecology \& Obstetrics. (1937) 38, no. 6, 1088-1200Link provided by the sponsor.
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.
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.