Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Assiut University
- Enrollment
- 300
- Primary Endpoint
- percentage of results of products of conception assessed by histopathological evaluation
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 17 Years to 40 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
surgical termination
Intervention: surgical and medical evacuation (Procedure)
medical termination
Intervention: surgical and medical evacuation (Procedure)
Outcomes
Primary Outcomes
percentage of results of products of conception assessed by histopathological evaluation
Time Frame: one year
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 Outcomes
- rate of participants show chronic histiocytic intervillositis in histopathological evaluation(one year)
Investigators
MOHAMMED HAGGAG HASHIM
Principal Investigator
Assiut University
