Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions

Conditions
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Recurrent Abortion

Intervention / Treatment
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* Procedure: surgical and medical evacuation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgical termination<br> | Procedure: surgical and medical evacuation<br>* 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<br>|
| Active Comparator: medical termination<br> | Procedure: surgical and medical evacuation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one year |