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

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

Study Contact Backup

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.

Publications and helpful links

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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

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.

Clinical Trials on Placenta Accreta / Percreta

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