Recurrent Pregnancy LossNCT01542411
Effectiveness of Aspirin in Compare With Heparin Plus Aspirin in Recurrent Pregnancy Loss Treatment
An observational study of Recurrent Pregnancy Loss, run by Yazd Medical University at 1 site in Iran.
Trial summary
This study evaluated the effect of anticoagulant treatment on the live-birth rate in women with a history of at least two continuous unexplained miscarriages or thrombophilia. It also compared two methods of treatment with aspirin and aspirin plus heparin. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Pregnancy Loss
- How many people
- 520 participants
- Where
- 1 siteIran
- Study dates
- Apr 2008to not given
- 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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This project evaluated 520 women with unexplained recurrent miscarriage for four years. They had referred to recurrent abortion clinic of Yazd Reproductive sciences institute. Women with unexplained recurrent miscarriage included in this study
Who may be able to join
- unexplained recurrent miscarriage,
- women had previous venous or arterial thromboembolism or who were heterozygous or homozygous for mutations for FV Leiden G1691A, prothrombin gene G20210A (FII G20210A), and methyltetrahydrofolate reductase C677T (MTHFR C677T)
Who cannot join
- abnormal karyotypes of both partners,
- uterine and cervical anatomical disorders on pelvic ultrasonography or hysteroscopy,
- abnormal ovaries and abnormal endocrine tests.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluated the effect of anticoagulant treatment on the live-birth rate in women with a history of at least two continuous unexplained miscarriages or thrombophilia. It also compared two methods of treatment with aspirin and aspirin plus heparin.
- Conditions
- Recurrent Pregnancy Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| recurrent pregnancy loss | Not described | |
| thrombophilia, aspirin | Not described | |
| heparin | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy LossStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yazd Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tahere Jahaninejad, MSC, Principal investigator, Yazd Shahid Sadoughi Medical Sciences University and Health Services, Yazd, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542411
- Sponsor's protocol ID
- 2362
- Status last verified
- Feb 2012
- First submitted
- 25 Feb 2012
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aspirin in Compare With Heparin Plus Aspirin in Recurrent Pregnancy Loss Treatment
- ClinicalTrials.gov ID
- NCT01542411
- Acronym / sponsor ID
- 2362
- Conditions
- Recurrent Pregnancy Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Yazd Medical UniversityUniversity, hospital or other
- Study start
- Apr 2008
- First posted
- 2 Mar 2012 (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.
This study evaluated the effect of anticoagulant treatment on the live-birth rate in women with a history of at least two continuous unexplained miscarriages or thrombophilia. It also compared two methods of treatment with aspirin and aspirin plus heparin.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| recurrent pregnancy loss | – | – |
| thrombophilia, aspirin | – | – |
| heparin | – | – |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This project evaluated 520 women with unexplained recurrent miscarriage for four years. They had referred to recurrent abortion clinic of Yazd Reproductive sciences institute. Women with unexplained recurrent miscarriage included in this study
Key inclusion criteria (2 listed)
- unexplained recurrent miscarriage,
- women had previous venous or arterial thromboembolism or who were heterozygous or homozygous for mutations for FV Leiden G1691A, prothrombin gene G20210A (FII G20210A), and methyltetrahydrofolate reductase C677T (MTHFR C677T)
Key exclusion criteria (3 listed)
- abnormal karyotypes of both partners,
- uterine and cervical anatomical disorders on pelvic ultrasonography or hysteroscopy,
- abnormal ovaries and abnormal endocrine tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Mar 2012.
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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.
Tahere Jahaninejad, MSC principal investigator
Yazd Shahid Sadoughi Medical Sciences University and Health Services, Yazd, Iran
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 Pregnancy Loss, run by Yazd Medical University at 1 site in Iran.
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 2 inclusion and 3 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 2 Mar 2012. 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 Iran. 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.
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 2 Mar 2012.