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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04917016
Enrollment
200
Registered
2021-06-08
Start date
2019-12-01
Completion date
2021-02-28
Last updated
2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retained Products of Conception

Keywords

Hysteroscopy, Ultrasound

Brief 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.

Interventions

DIAGNOSTIC_TESTPlasma B-HCG levels

Blood sample

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
B-HCG levelsFrom randomization to the day of surgery, assessed up to 3 monthsPlasma levels of B-HCG measured in mU/mL in women undergoing hysteroscopy for removal of RPOC

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026