Recurrent AbortionNCT04326595
Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions
A study testing surgical and medical evacuation in people with Recurrent Abortion, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 17 to 40 years, women only
- Conditions the study is for
- Recurrent Abortion
- What is being tested?
- surgical and medical evacuation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2020to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- all pregnants with clinical symptoms and signs of abortion
- fit for medical induction of abortion
- fit for surgical procedure
Who cannot join
- threatened abortion
- complete abortion
- unfit participants for medical abortion
- unfit participants for surgical procedure
Trial locations and contacts
No sites are listed yet.
About this study
- 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.
Read the 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 .
- Conditions
- Recurrent Abortion
- Being tested
- surgical and medical evacuation
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical and medical evacuationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| surgical termination | Active comparator | Not described Receives: Procedure: surgical and medical evacuation |
| medical termination | Active comparator | Not described Receives: Procedure: surgical and medical evacuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (1)
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start20 Dec 2020 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Recurrent AbortionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMMED HAGGAG HASHIM, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326595
- Sponsor's protocol ID
- histopathology in abortion
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 848521WARBURTON 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.
PubMed 14131871Doubilet 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.
PubMed 24106937Lemmers 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.
PubMed 29266169Luise 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.
PubMed 11950733
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathological Evaluation of Product of Conception in Sporadic and Recurrent Abortions
- ClinicalTrials.gov ID
- NCT04326595
- Acronym / sponsor ID
- histopathology in abortion
- Conditions
- Recurrent Abortion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2020 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| surgical termination | Active comparator | Procedure: surgical and medical evacuation |
| medical termination | Active comparator | Procedure: surgical and medical evacuation |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- all pregnants with clinical symptoms and signs of abortion
- fit for medical induction of abortion
- fit for surgical procedure
Key exclusion criteria (4 listed)
- threatened abortion
- complete abortion
- unfit participants for medical abortion
- unfit participants for surgical procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical and medical evacuationsurgical 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 | Procedure or surgery | medical termination, surgical termination |
Primary outcome
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
1 secondary outcome
rate of participants show chronic histiocytic intervillositis in histopathological evaluation
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Background: PubMed 848521Poland 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.
- Background: PubMed 14131871WARBURTON 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.
- Background: PubMed 24106937Doubilet 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.
- Background: PubMed 29266169Lemmers 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.
- Background: PubMed 11950733Luise 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing surgical and medical evacuation in people with Recurrent Abortion, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohammed haggag hashim, resident (01065594274, midomido_com@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of results of products of conception assessed by histopathological evaluation (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04326595, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.