Thrombophilia With Recurrent Pregnancy LossPhase 4NCT02986594
Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla
A Phase 4 study testing Aspirin and Heparin in people with Thrombophilia With Recurrent Pregnancy Loss, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial summary
In this clinical cohort study, the investigators observe the efficacy of low molecular weight heparin in the treatment of thrombophilia with recurrent pregnancy loss with a prospective randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Thrombophilia With Recurrent Pregnancy Loss
- What is being tested?
- Aspirin and Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Oct 2019
- Phase
- Phase 4
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Woman who had their Second miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form.
Who cannot join
- having experiencedsevere allergies, trauma history and/or operation history within 3 months
- with a history of mental illness and/or family history of mental illness
- limb disabled
- taking medicine within one month
- suffering major events or having mood swings
- with a history of recurrent pregnancy loss
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- having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine rotine)
- Chromosome aberrations in anyone of the couple.
- patients who have drug contraindications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai first Maternity and Infant health hospital, Tong Ji University
Shanghai, 200051
Shihua Bao, PhD, 86-21-20261430 ext. 2012, baoshihua@tongji.edu.cn
Yan Yan, Master, 86-21-20261430 ext. 2012, shtjyanyan@163.com
About this study
Official title: Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
In this clinical cohort study, the investigators observe the efficacy of low molecular weight heparin in the treatment of thrombophilia with recurrent pregnancy loss with a prospective randomized controlled trial.
- Being tested
- Aspirin, Heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
HeparinDrug
| Study group | Role | What they receive |
|---|---|---|
| aspirin group | Experimental | low dose aspirin, 75-100mg, bid, after pregnancy Receives: Drug: Aspirin |
| low molecular weight heparin group | Experimental | low molecular weight heparin, 4100u, qd, after pregnancy Receives: Drug: Heparin |
| combination group | Experimental | low molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy Receives: Drug: Aspirin; Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
D-Dimer
Measured: through study completion, an average of 3 year
Secondary outcomes (1)
BMI in kg/m^2
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombophilia With 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shihua Bao, Shanghai First Maternity and Infant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986594
- Sponsor's protocol ID
- ShanghaiFIMH-0002
- Status last verified
- Nov 2016
- First submitted
- 27 Nov 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
- ClinicalTrials.gov ID
- NCT02986594
- Acronym / sponsor ID
- ShanghaiFIMH-0002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 8 Dec 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.
In this clinical cohort study, the investigators observe the efficacy of low molecular weight heparin in the treatment of thrombophilia with recurrent pregnancy loss with a prospective randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aspirin group | Experimental | Drug: Aspirinlow dose aspirin, 75-100mg, bid, after pregnancy |
| low molecular weight heparin group | Experimental | Drug: Heparinlow molecular weight heparin, 4100u, qd, after pregnancy |
| combination group | Experimental | Drug: Aspirin, Drug: Heparinlow molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Woman who had their Second miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form.
Key exclusion criteria (9 listed)
- having experiencedsevere allergies, trauma history and/or operation history within 3 months
- with a history of mental illness and/or family history of mental illness
- limb disabled
- taking medicine within one month
- suffering major events or having mood swings
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 |
|---|---|---|
| Aspirin | Drug | aspirin group, combination group |
| Heparin | Drug | combination group, low molecular weight heparin group |
Primary outcome
D-Dimer
Time frame: through study completion, an average of 3 year
1 secondary outcome
BMI in kg/m^2
Time frame: through study completion, an average of 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
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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.
Shanghai first Maternity and Infant health hospital, Tong Ji University
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and Heparin in people with Thrombophilia With Recurrent Pregnancy Loss, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
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 1 inclusion and 9 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 9 Dec 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
D-Dimer (time frame: through study completion, an average of 3 year). 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 9 Dec 2016.