B-HCG Levels in Women Diagnosed With Retained Products of Conception
NCT ID: NCT04917016
Last Updated: 2021-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2019-12-01
2021-02-28
Brief Summary
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The production and secretion of the B-HCG occurs in the placenta and begins after blastocyst implantation. The B-HCG levels increase in other placental pathologies such as gestational trophoblastic disease (GTD). Accordingly, the investigators hypothesized that in cases of placental remnants a secretion of B-HCG may be detected and quantified.
In this prospective, non-interventional study the investigators' aim is to examine whether B-HCG can be used as a marker for detecting placental remnants, compared to the currently accepted sonographic method. For this purpose, the investigators will examine the levels of B-HCG in participants undergoing hysteroscopy for removal of RPOC.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study group
Women undergoing hysteroscopy for removal of RPOC
Plasma B-HCG levels
Blood sample
Interventions
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Plasma B-HCG levels
Blood sample
Eligibility Criteria
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Inclusion Criteria
* Admitted for hysteroscopy for RPOC removal following delivery
* Admitted for hysteroscopy for RPOC removal following abortion.
Exclusion Criteria
* No pathology specimen available.
18 Years
45 Years
FEMALE
No
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Assaf Harofeh MC
Noam Smorgick MD, Director of Minimally Invasive Gynecologic Surgery
Principal Investigators
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Noam Smorgick, MD Msc
Role: PRINCIPAL_INVESTIGATOR
Assaf-Harofeh Medical Center
Locations
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Shamir Medical Center
Be’er Ya‘aqov, , Israel
Countries
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References
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Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096.
Barel O, Krakov A, Pansky M, Vaknin Z, Halperin R, Smorgick N. Intrauterine adhesions after hysteroscopic treatment for retained products of conception: what are the risk factors? Fertil Steril. 2015 Mar;103(3):775-9. doi: 10.1016/j.fertnstert.2014.11.016. Epub 2014 Dec 17.
Smorgick N, Barel O, Fuchs N, Ben-Ami I, Pansky M, Vaknin Z. Hysteroscopic management of retained products of conception: meta-analysis and literature review. Eur J Obstet Gynecol Reprod Biol. 2014 Feb;173:19-22. doi: 10.1016/j.ejogrb.2013.11.020. Epub 2013 Dec 1.
Smorgick N, Krakov A, Maymon R, Betser M, Tovbin J, Pansky M. Postpartum Retained Products of Conception: A Novel Approach to Follow-Up and Early Diagnosis. Ultraschall Med. 2018 Dec;39(6):643-649. doi: 10.1055/s-0043-113817. Epub 2017 Sep 21.
van den Bosch T, Daemen A, Van Schoubroeck D, Pochet N, De Moor B, Timmerman D. Occurrence and outcome of residual trophoblastic tissue: a prospective study. J Ultrasound Med. 2008 Mar;27(3):357-61. doi: 10.7863/jum.2008.27.3.357.
Other Identifiers
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0195-19-ASF
Identifier Type: -
Identifier Source: org_study_id
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