Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions

NCT ID: NCT04326595

Last Updated: 2020-03-31

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-20

Study Completion Date

2022-05-30

Brief Summary

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1. To evaluate histopathological findings of products of conception in both sporadic and recurrent miscarriage.
2. To determine the prevalence of chronic histiocytic intervillositis in both sporadic and recurrent miscarriage.

Detailed Description

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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 .

Conditions

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Recurrent Abortion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

1. Full detailed history taking .
2. Through clinical examination .
3. pregnancy was confirmed by ultrasound examination or serum beta human chorionic gonadotropins (β-HCG) level for patients.
4. All patients had routine laboratory tests including blood group, Rh factor, complete blood count, and electrolytes.
5. Then the all tissues obtained at evacuation should be submitted for histopathological examination
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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surgical termination

Group Type ACTIVE_COMPARATOR

surgical and medical evacuation

Intervention Type PROCEDURE

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

medical termination

Group Type ACTIVE_COMPARATOR

surgical and medical evacuation

Intervention Type PROCEDURE

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

Interventions

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surgical and medical evacuation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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MOHAMMED HAGGAG HASHIM

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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mohammed haggag hashim, resident

Role: CONTACT

Phone: 01065594274

Email: [email protected]

Tarek khalaf Al-Hussaini, prof.dr.

Role: CONTACT

Phone: 01223434597

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 848521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14131871 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24106937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29266169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11950733 (View on PubMed)

Other Identifiers

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histopathology in abortion

Identifier Type: -

Identifier Source: org_study_id