Recurrent AbortionNCT02088424
the Insulin Resistance in Recurrent Miscarriage IN RECURRENT ABORTION
An observational study of Recurrent Abortion, run by Ain Shams University at 1 site in Egypt.
Trial summary
THE INSULIN RESISTANCE IN RECURRENT ABORTION Read more about this study
- Who is it for?
- Ages 23 to 40 years, women only
- Conditions the study is for
- Recurrent Abortion
- What is being tested?
- insulin resistance(fasting glucose/fasting insulin)
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2014to Apr 2015
- How long will I take part?
- 6 Months
- 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 23 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 1. Women in the child bearing period between 23-40 years. 2. All patients are pregnant. 3. The gestational age of both groups 6-13 weeks
Who may be able to join
- Women in the child bearing period between 23-40 years.
- All patients are pregnant.
- The gestational age of both groups 6-13 weeks
Who cannot join
- Patients with gestational diabetes and gestational impaired glucose tolerance.
- The patients who took medication that could affect glucose metabolism at the time of the study
- Patients with other causes of recurrent abortion as(thyroid dysfunction, uterine anomalies chromosomal abnormalities, antiphspholipid antibody syndrome, uterine anomalies and TORCH syndrome).
- Patients with PCOS.
- Obese patients(BMI>30)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain shams maternity hospital
Cairo
ABDELLATIF G ELKHOLY, M D
ABDELLATIF G ELKHOLY, M D
About this study
Official title: Insulin Resistance and Recurrent Abortion
THE INSULIN RESISTANCE IN RECURRENT ABORTION
Read the detailed description
THE ROLE OF INSULIN RESISTANCE IN RECURRENT ABORTION
- Conditions
- Recurrent Abortion
- Being tested
- insulin resistance(fasting glucose/fasting insulin)
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin resistance(fasting glucose/fasting insulin)Other
insulin resistance(fasting glucose/fasting insulin )
| Study group | Role | What they receive |
|---|---|---|
| group A | cases with recurrent abortion with insulin resisance Receives: Other: insulin resistance(fasting glucose/fasting insulin) | |
| GROUP B | cases that are pregnant with no history of recurrent abortion with no insulin resistance Receives: Other: insulin resistance(fasting glucose/fasting insulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting blood glucose
Click here for more information about this study: the role of insulin resistance in recurrent abortion
Measured: 3 month
Secondary outcomes (1)
fasting Insulin
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2014 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent AbortionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed ahmed selem, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088424
- Sponsor's protocol ID
- mohd-1978
- Status last verified
- Mar 2014
- First submitted
- 8 Mar 2014
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance and Recurrent Abortion
- ClinicalTrials.gov ID
- NCT02088424
- Acronym / sponsor ID
- mohd-1978
- Conditions
- Recurrent Abortion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 17 Mar 2014 (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 INSULIN RESISTANCE IN RECURRENT ABORTION
Detailed description
THE ROLE OF INSULIN RESISTANCE IN RECURRENT ABORTION
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Other: insulin resistance(fasting glucose/fasting insulin)cases with recurrent abortion with insulin resisance |
| GROUP B | – | Other: insulin resistance(fasting glucose/fasting insulin)cases that are pregnant with no history of recurrent abortion with no insulin resistance |
Who may qualify
- Ages
- 23 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 1. Women in the child bearing period between 23-40 years. 2. All patients are pregnant. 3. The gestational age of both groups 6-13 weeks
Key inclusion criteria (3 listed)
- Women in the child bearing period between 23-40 years.
- All patients are pregnant.
- The gestational age of both groups 6-13 weeks
Key exclusion criteria (5 listed)
- Patients with gestational diabetes and gestational impaired glucose tolerance.
- The patients who took medication that could affect glucose metabolism at the time of the study
- Patients with other causes of recurrent abortion as(thyroid dysfunction, uterine anomalies chromosomal abnormalities, antiphspholipid antibody syndrome, uterine anomalies and TORCH syndrome).
- Patients with PCOS.
- Obese patients(BMI>30)
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 |
|---|---|---|
| insulin resistance(fasting glucose/fasting insulin)insulin resistance(fasting glucose/fasting insulin ) | Other | GROUP B, group A |
Primary outcome
fasting blood glucose
Time frame: 3 month
Click here for more information about this study: the role of insulin resistance in recurrent abortion
1 secondary outcome
fasting Insulin
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
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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.
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 Abortion, run by Ain Shams 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 5 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 17 Mar 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed a selem, master (00201116724786, drghost_3000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting blood glucose (time frame: 3 month). 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 17 Mar 2014.