NCT04917016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

1.2 years

First QC Date

January 13, 2021

Last Update Submit

June 7, 2021

Conditions

Retained Products of Conception

Keywords

HysteroscopyUltrasound

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Study group

Women undergoing hysteroscopy for removal of RPOC

Diagnostic Test: Plasma B-HCG levels

Interventions

Plasma B-HCG levelsDIAGNOSTIC_TEST

Blood sample

Study group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women \>18 years admitted for hysteroscopy for RPOC removal following delivery of abortion.

You may qualify if:

  • \>18 years old
  • Admitted for hysteroscopy for RPOC removal following delivery
  • Admitted for hysteroscopy for RPOC removal following abortion.

You may not qualify if:

  • Low suspicion of RPOC by clinical or ultrasound examination.
  • No pathology specimen available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shamir Medical Center

Be’er Ya‘aqov, 70200, Israel

Location

Related Publications (5)

  • 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.

    PMID: 18406834RESULT

  • 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.

    PMID: 25527235RESULT

  • 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.

    PMID: 24332096RESULT

  • 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.

    PMID: 28934813RESULT

  • 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.

    PMID: 18314513RESULT

Study Officials

  • Noam Smorgick, MD Msc

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Noam Smorgick MD, Director of Minimally Invasive Gynecologic Surgery

Study Record Dates

First Submitted

January 13, 2021

First Posted

June 8, 2021

Study Start

December 1, 2019

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

June 8, 2021

Record last verified: 2021-06

Locations

IL(1)