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Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions

Primary Purpose

Recurrent Abortion

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surgical and medical evacuation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Recurrent Abortion

Eligibility Criteria

17 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • all pregnants with clinical symptoms and signs of abortion
  • fit for medical induction of abortion
  • fit for surgical procedure

Exclusion Criteria:

  • threatened abortion
  • complete abortion
  • unfit participants for medical abortion
  • unfit participants for surgical procedure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    surgical termination

    medical termination

    Arm Description

    Outcomes

    Primary Outcome Measures

    percentage of results of products of conception assessed by histopathological evaluation
    to asses the result of analysis of products of abortion and divide them into groups according to the results and asses percentage of each type types predicted :1-products of conception 2-no products of conception 3-partial moel 4-complete mole 5-Arias-stella reaction 6-others

    Secondary Outcome Measures

    rate of participants show chronic histiocytic intervillositis in histopathological evaluation
    assesment of chronic histiocytic intervillositis by detection of massive perivillous histiocytosis in placental tissue by histopathological evaluation

    Full Information

    First Posted
    March 25, 2020
    Last Updated
    March 27, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04326595
    Brief Title
    Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions
    Official Title
    Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 20, 2020 (Anticipated)
    Primary Completion Date
    December 30, 2021 (Anticipated)
    Study Completion Date
    May 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To evaluate histopathological findings of products of conception in both sporadic and recurrent miscarriage. To determine the prevalence of chronic histiocytic intervillositis in both sporadic and recurrent miscarriage.
    Detailed Description
    Early miscarriage is a term used to describe the loss of pregnancy within the first 12 weeks of gestation .This diagnosis concerns 10-15% of all pregnancies and is made based on additional tests such as serial determinations of chorionic gonadotropin concentration and imaging examinations ultrasonography. Depending on the clinical presentation and results of ultrasonography, miscarriages can be divided into complete spontaneous miscarriage, and incomplete miscarriage, when the width of the echo of residual tissues in the uterine cavity exceeds 10 mm on ultrasonography and is accompanied by the presence of clinical symptoms such as vaginal bleeding and abdominal pain .The other type of miscarriage is defined as retained products of conception (RPOC) and refers to the state when the gestational sac contains the embryo with crown-rump length (CRL) of > 7 mm but embryonic cardiac activity is invisible. Empty gestational sac is diagnosed when the gestational sac with a diameter of > 25 mm and without an embryo is visible in the uterine cavity on ultrasonography . Histopathological examination of products of conception is an integral and a routine component of the management of patients with early pregnancy failure . Two important primary reasons for such an examination are to confirm the presence of an intrauterine gestation and to exclude gestational trophoblastic disease in the form of partial or complete hydatidiform mole .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Abortion

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Full detailed history taking . Through clinical examination . pregnancy was confirmed by ultrasound examination or serum beta human chorionic gonadotropins (β-HCG) level for patients. All patients had routine laboratory tests including blood group, Rh factor, complete blood count, and electrolytes. Then the all tissues obtained at evacuation should be submitted for histopathological examination
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    surgical termination
    Arm Type
    Active Comparator
    Arm Title
    medical termination
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    surgical and medical evacuation
    Intervention Description
    surgical evacuation:the dilation of the cervix and surgical evacuation of the uterus (potentially including the fetus, placenta and other tissue) medical evacuation: induction of abortion by the use of ecbolics
    Primary Outcome Measure Information:
    Title
    percentage of results of products of conception assessed by histopathological evaluation
    Description
    to asses the result of analysis of products of abortion and divide them into groups according to the results and asses percentage of each type types predicted :1-products of conception 2-no products of conception 3-partial moel 4-complete mole 5-Arias-stella reaction 6-others
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    rate of participants show chronic histiocytic intervillositis in histopathological evaluation
    Description
    assesment of chronic histiocytic intervillositis by detection of massive perivillous histiocytosis in placental tissue by histopathological evaluation
    Time Frame
    one year

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    All of the patients had vaginal bleeding and pelvic pain. After vaginal examination , transvaginal ultrasonography findings and serum β-HCG levels were performed to verify the diagnosis. The cases were classified as complete, incomplete, missed, or anembryonic miscarriage according to the guidelines of the Royal College of Obstetrics and Gynecology (RCOG) on the basis of transvaginal ultrasonography[5]. Missed miscarriage was defined as the presence of a non-viable fetus. An intact gestational sac with an absence of fetal echo was diagnosed as an anembryonic miscarriage. Incomplete miscarriage was defined as the presence of heterogeneous tissues (with or without a gestational sac) distorting the endometrial midline echo by transvaginal ultrasonography.
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: all pregnants with clinical symptoms and signs of abortion fit for medical induction of abortion fit for surgical procedure Exclusion Criteria: threatened abortion complete abortion unfit participants for medical abortion unfit participants for surgical procedure
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohammed haggag hashim, resident
    Phone
    01065594274
    Email
    midomido_com@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tarek khalaf Al-Hussaini, prof.dr.
    Phone
    01223434597
    Email
    Tarekalhussaini@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    848521
    Citation
    Poland BJ, Miller JR, Jones DC, Trimble BK. Reproductive counseling in patients who have had a spontaneous abortion. Am J Obstet Gynecol. 1977 Apr 1;127(7):685-91. doi: 10.1016/0002-9378(77)90240-x.
    Results Reference
    background
    PubMed Identifier
    14131871
    Citation
    WARBURTON D, FRASER FC. SPONTANEOUS ABORTION RISKS IN MAN: DATA FROM REPRODUCTIVE HISTORIES COLLECTED IN A MEDICAL GENETICS UNIT. Am J Hum Genet. 1964 Mar;16(1):1-25. No abstract available.
    Results Reference
    background
    PubMed Identifier
    24106937
    Citation
    Doubilet PM, Benson CB, Bourne T, Blaivas M; Society of Radiologists in Ultrasound Multispecialty Panel on Early First Trimester Diagnosis of Miscarriage and Exclusion of a Viable Intrauterine Pregnancy; Barnhart KT, Benacerraf BR, Brown DL, Filly RA, Fox JC, Goldstein SR, Kendall JL, Lyons EA, Porter MB, Pretorius DH, Timor-Tritsch IE. Diagnostic criteria for nonviable pregnancy early in the first trimester. N Engl J Med. 2013 Oct 10;369(15):1443-51. doi: 10.1056/NEJMra1302417. No abstract available.
    Results Reference
    background
    PubMed Identifier
    29266169
    Citation
    Lemmers M, Verschoor MAC, Bossuyt PM, Huirne JAF, Spinder T, Nieboer TE, Bongers MY, Janssen IAH, Van Hooff MHA, Mol BWJ, Ankum WM, Bosmans JE; MisoREST study group. Cost-effectiveness of curettage vs. expectant management in women with an incomplete evacuation after misoprostol treatment for first-trimester miscarriage: a randomized controlled trial and cohort study. Acta Obstet Gynecol Scand. 2018 Mar;97(3):294-300. doi: 10.1111/aogs.13283. Epub 2018 Jan 19.
    Results Reference
    background
    PubMed Identifier
    11950733
    Citation
    Luise C, Jermy K, May C, Costello G, Collins WP, Bourne TH. Outcome of expectant management of spontaneous first trimester miscarriage: observational study. BMJ. 2002 Apr 13;324(7342):873-5. doi: 10.1136/bmj.324.7342.873.
    Results Reference
    background
    Links:
    URL
    https://doi.org/10.1155/2014/863482
    Description
    Related Info

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    Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions

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