Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions

Assiut University

Status: Unknown

Conditions: Recurrent Abortion

Treatments: Procedure: surgical and medical evacuation

Study type: Interventional

Funder types: Other

Identifiers

NCT04326595

histopathology in abortion

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 300 estimated patients

Sex: Female

Ages: 17 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

surgical termination

Active Comparator group

Treatment:

Procedure: surgical and medical evacuation

medical termination

Active Comparator group

Treatment:

Procedure: surgical and medical evacuation