Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions

NCT04326595 | Unknown

• 1 other identifier: histopathology in abortion
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To evaluate histopathological findings of products of conception in both sporadic and recurrent miscarriage.
2. 2.To determine the prevalence of chronic histiocytic intervillositis in both sporadic and recurrent miscarriage.

Conditions

Recurrent Abortion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• rate of participants show chronic histiocytic intervillositis in histopathological evaluation

  one year

Study Arms (2)

surgical termination

ACTIVE COMPARATOR

Procedure: surgical and medical evacuation

medical termination

ACTIVE COMPARATOR

Procedure: surgical and medical evacuation

Interventions

surgical and medical evacuation PROCEDURE

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

medical termination; surgical termination

Eligibility Criteria

• Age: 17 Years - 40 Years
• Gender Eligibility Details: All of the patients had vaginal bleeding and pelvic pain. After vaginal examination , transvaginal ultrasonography findings and serum β-HCG levels were performed to verify the diagnosis. The cases were classified as complete, incomplete, missed, or anembryonic miscarriage according to the guidelines of the Royal College of Obstetrics and Gynecology (RCOG) on the basis of transvaginal ultrasonography\[5\]. Missed miscarriage was defined as the presence of a non-viable fetus. An intact gestational sac with an absence of fetal echo was diagnosed as an anembryonic miscarriage. Incomplete miscarriage was defined as the presence of heterogeneous tissues (with or without a gestational sac) distorting the endometrial midline echo by transvaginal ultrasonography.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• all pregnants with clinical symptoms and signs of abortion
• fit for medical induction of abortion
• fit for surgical procedure

You may not qualify if:

• threatened abortion
• complete abortion
• unfit participants for medical abortion
• unfit participants for surgical procedure

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• 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. doi: 10.1016/0002-9378(77)90240-x.

  PMID: 848521 BACKGROUND

• 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):1-25. No abstract available.

  PMID: 14131871 BACKGROUND

• 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. No abstract available.

  PMID: 24106937 BACKGROUND

• 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.

  PMID: 29266169 BACKGROUND

• 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. doi: 10.1136/bmj.324.7342.873.

  PMID: 11950733 BACKGROUND

MeSH Terms

Conditions

Abortion, Habitual

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

mohammed haggag hashim, resident

CONTACT

01065594274; midomido_com@yahoo.com

Tarek khalaf Al-Hussaini, prof.dr.

CONTACT

01223434597; Tarekalhussaini@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1. Full detailed history taking . 2. Through clinical examination . 3. pregnancy was confirmed by ultrasound examination or serum beta human chorionic gonadotropins (β-HCG) level for patients. 4. All patients had routine laboratory tests including blood group, Rh factor, complete blood count, and electrolytes. 5. Then the all tissues obtained at evacuation should be submitted for histopathological examination

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 30, 2020
• Study Start: December 20, 2020
• Primary Completion: December 30, 2021
• Study Completion: May 30, 2022
• Last Updated: March 31, 2020

Record last verified: 2020-03