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Completed

NCT Number: NCT04917016

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Shamir Medical Center

Be’er Ya‘aqov, 70200, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plasma B-HCG levels

Diagnostic Test

Blood sample

Primary outcomes

  1. B-HCG levels

    Time frame: From randomization to the day of surgery, assessed up to 3 months

    Plasma levels of B-HCG measured in mU/mL in women undergoing hysteroscopy for removal of RPOC

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2021
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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