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
About this trial
This is an interventional screening trial for Recurrent Abortion
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
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
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
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Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions
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