Recurrent MiscarriageEPK-RMNCT02694367
Expression of EPK in Recurrent Miscarriage
An observational study of Recurrent Miscarriage, run by Assiut University at 1 site in Egypt.
Trial summary
The present study is based on hypotheses that some as yet unknown genetic factors may result in recurrent miscarriage (RM). Consequently, the main aim of this study was to gain new information about the underlying genetic causes of RM in the Egyptian population and to investigate the expression of ERK and p-ERK… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Recurrent Miscarriage
- What is being tested?
- Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Jan 2016
- Phase
- Observational
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women fulfilling the eligibility criteria had been tested and complete history and examination was done
Who may be able to join
- Gestational age less than 12 weeks.
- no uterine abnormalities (examined by ultrasonography or hysterosonogram)
- previous history of RM, defined as two or more consecutive miscarriages
Who cannot join
- Gestational age 12 weeks or more.
- Endocrine etiology like (thyroid dysfunction, and uncontrolled diabetes mellitus).
- Antiphospholipid syndrome, inherited thrombophilias, alloimmune causes.
- Uterine anatomic anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MAP Kinase Signaling Pathways Through ERK and p-ERK Protein in Human Placenta of Women With Recurrent Miscarriage
The present study is based on hypotheses that some as yet unknown genetic factors may result in recurrent miscarriage (RM). Consequently, the main aim of this study was to gain new information about the underlying genetic causes of RM in the Egyptian population and to investigate the expression of ERK and p-ERK protein in human placenta and their corresponding tissue, to assess the significance of MAPK signal pathway in progression of recurrent miscarriage and PI3K-Akt Pathway.
- Conditions
- Recurrent Miscarriage
- Being tested
- Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins
- Keywords
- genetic basis
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigate the MAP kinase signaling pathways through ERK and p-ERK proteinsOther
| Study group | Role | What they receive |
|---|---|---|
| Recurrent miscarriage group | Women with previous history of RM, defined as two or more consecutive miscarriages Receives: Other: Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins | |
| Control group | Women with no history of RM Receives: Other: Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins |
What is being measured
The primary outcome is the main question the study is designed to answer.
The levels of ERK and AKT in placenta
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MiscarriageStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694367
- Sponsor's protocol ID
- ERK
- Acronym
- EPK-RM
- Status last verified
- Feb 2016
- First submitted
- 24 Feb 2016
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAP Kinase Signaling Pathways Through ERK and p-ERK Protein in Human Placenta of Women With Recurrent Miscarriage
- ClinicalTrials.gov ID
- NCT02694367
- Acronym / sponsor ID
- EPK-RM / ERK
- Conditions
- Recurrent Miscarriage
- Keywords
- genetic basis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Feb 2016 (estimated)
- 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.
The present study is based on hypotheses that some as yet unknown genetic factors may result in recurrent miscarriage (RM). Consequently, the main aim of this study was to gain new information about the underlying genetic causes of RM in the Egyptian population and to investigate the expression of ERK and p-ERK protein in human placenta and their corresponding tissue, to assess the significance of MAPK signal pathway in progression of recurrent miscarriage and PI3K-Akt Pathway.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent miscarriage group | – | Other: Investigate the MAP kinase signaling pathways through ERK and p-ERK proteinsWomen with previous history of RM, defined as two or more consecutive miscarriages |
| Control group | – | Other: Investigate the MAP kinase signaling pathways through ERK and p-ERK proteinsWomen with no history of RM |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women fulfilling the eligibility criteria had been tested and complete history and examination was done
Key inclusion criteria (3 listed)
- Gestational age less than 12 weeks.
- no uterine abnormalities (examined by ultrasonography or hysterosonogram)
- previous history of RM, defined as two or more consecutive miscarriages
Key exclusion criteria (4 listed)
- Gestational age 12 weeks or more.
- Endocrine etiology like (thyroid dysfunction, and uncontrolled diabetes mellitus).
- Antiphospholipid syndrome, inherited thrombophilias, alloimmune causes.
- Uterine anatomic anomalies
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 |
|---|---|---|
| Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins | Other | Control group, Recurrent miscarriage group |
Primary outcome
The levels of ERK and AKT in placenta
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Miscarriage, run by Assiut University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The levels of ERK and AKT in placenta (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Feb 2016; AzTrials last refreshed its copy on 30 Oct 2026.