B-HCG Levels in Women Diagnosed With Retained Products of Conception

Retained Products of Conception Clinical Trial

Official title:

B-HCG Levels in Women Undergoing Hysteroscopy for Removal of Retained Products of Conception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04917016
• Other study ID #: 0195-19-ASF
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Retained Products of Conception

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