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Clinical Trials/NCT04326595
NCT04326595UnknownNot Applicable

Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions

Assiut University0 sites300 target enrollmentStarted: December 20, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
300
Primary Endpoint
percentage of results of products of conception assessed by histopathological evaluation

Study Overview

Brief Summary

  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

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

Active Comparator

Intervention: surgical and medical evacuation (Procedure)

medical termination

Active Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

MOHAMMED HAGGAG HASHIM

Principal Investigator

Assiut University

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