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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04917016
Other study ID # 0195-19-ASF
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2019
Est. completion date February 28, 2021

Study information

Verified date June 2021
Source Assaf-Harofeh Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retained Products of Conception (RPOC) is a condition where gestational tissue remains in the uterus after birth or after a surgical or medical abortion. This condition may cause significant bleeding, infection, and long-term intrauterine adhesions associated with fertility problems and pregnancy complications (Asherman's syndrome). RPOC are diagnosed according to the clinical and ultrasound findings (such as an echogenic foci in the uterine cavity with Doppler blood flows). However, the diagnosis of RPOC by clinic and ultrasound characteristics is inaccurate and false positive results are reported in up to 40% of women undergoing a surgical procedure for RPOC removal (most often by hysterosocpy). However, surgery also carries a risk of complications and intrauterine infections. Therefore, the need arises for additional tools to improve the diagnosis available today in order to minimize the need for surgical procedures as much as possible. 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date February 28, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - >18 years old - Admitted for hysteroscopy for RPOC removal following delivery - Admitted for hysteroscopy for RPOC removal following abortion. Exclusion Criteria: - Low suspicion of RPOC by clinical or ultrasound examination. - No pathology specimen available.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Plasma B-HCG levels
Blood sample

Locations

Country Name City State
Israel Shamir Medical Center Be'er Ya'aqov

Sponsors (1)

Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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 — View Citation

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 20 — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary B-HCG levels Plasma levels of B-HCG measured in mU/mL in women undergoing hysteroscopy for removal of RPOC From randomization to the day of surgery, assessed up to 3 months
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