B-HCG Levels in Women Diagnosed With Retained Products of Conception
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Study group Women undergoing hysteroscopy for removal of RPOC |
Diagnostic Test: Plasma B-HCG levels
Blood sample
|
Outcome Measures
Primary Outcome Measures
- B-HCG levels [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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years old
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Admitted for hysteroscopy for RPOC removal following delivery
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Admitted for hysteroscopy for RPOC removal following abortion.
Exclusion Criteria:
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Low suspicion of RPOC by clinical or ultrasound examination.
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No pathology specimen available.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shamir Medical Center | Be'er Ya'aqov | Israel | 70200 |
Sponsors and Collaborators
- Assaf-Harofeh Medical Center
Investigators
- Principal Investigator: Noam Smorgick, MD Msc, Shamir Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0195-19-ASF