Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions

Recurrent Abortion Clinical Trial

Official title:

Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04326595
• Other study ID #: histopathology in abortion
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 20, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: mohammed haggag hashim, resident
• Phone: 01065594274
• Email: midomido_com[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Recurrent Abortion

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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;16:1-25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

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