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

NCT ID: NCT04917016

Last Updated: 2021-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retained Products of Conception

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

Women undergoing hysteroscopy for removal of RPOC

Plasma B-HCG levels

Intervention Type DIAGNOSTIC_TEST

Blood sample

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Plasma B-HCG levels

Blood sample

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Assaf Harofeh MC

Noam Smorgick MD, Director of Minimally Invasive Gynecologic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Noam Smorgick, MD Msc

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shamir Medical Center

Be’er Ya‘aqov, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 18406834 (View on PubMed)

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. Epub 2014 Dec 17.

Reference Type RESULT
PMID: 25527235 (View on PubMed)

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 2013 Dec 1.

Reference Type RESULT
PMID: 24332096 (View on PubMed)

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.

Reference Type RESULT
PMID: 28934813 (View on PubMed)

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. doi: 10.7863/jum.2008.27.3.357.

Reference Type RESULT
PMID: 18314513 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0195-19-ASF

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fertility Post Placenta Accrete
NCT02821702 COMPLETED NA