Recurrent Pregnancy LossPhase 4NCT02990403
The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss
A Phase 4 study testing Aspirin, Heparin and Prednisone in people 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 are going to observe the efficacy of anti-coagulation and immune therapy in the treatment of 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
- Recurrent Pregnancy Loss
- What is being tested?
- Aspirin, Heparin and Prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to 22 Dec 2018
- 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 2 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 experienced severe 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.
- having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)
- chromosome aberrations in anyone of the couple.
- patients who have drugs 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
In this clinical cohort study, the investigators are going to observe the efficacy of anti-coagulation and immune therapy in the treatment of recurrent pregnancy loss with a prospective randomized controlled trial.
- Conditions
- Recurrent Pregnancy Loss
- Being tested
- Aspirin, Heparin, Prednisone, Immunoglobulin, Dydrogesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
HeparinDrug
PrednisoneDrug
ImmunoglobulinDrug
DydrogesteroneDrug
| Study group | Role | What they receive |
|---|---|---|
| aspirin+LMWH group | Experimental | aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd Receives: Drug: Aspirin; Drug: Heparin |
| aspirin+LMWH+immunoglobulin group | Experimental | aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks Receives: Drug: Aspirin; Drug: Heparin; Drug: Immunoglobulin |
| aspirin+LMWH+prednisone group | Experimental | aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd Receives: Drug: Aspirin; Drug: Heparin; Drug: Prednisone |
| aspirin+LMWH+IVIG+prednisone group | Experimental | aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd Receives: Drug: Aspirin; Drug: Heparin; Drug: Prednisone; Drug: Immunoglobulin |
| dydrogesterone group | Other | dydrogesterone 20-30mg/day, po, tid Receives: Drug: Dydrogesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth
live birth means success pregnancy（more than gestational age of 20 weeks）
Measured: through study completion, an average of 3 year
Secondary outcomes (3)
D-dimer
Measured: through study completion, an average of 3 year
Uterine artery blood flow
Measured: through study completion, an average of 3 year
human chorionic gonadotropin
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 posted13 Dec 2016 (estimated)
- Study startOct 2014
- Primary completion10 Jun 2017 (estimated)
- Study completion22 Dec 2018 (estimated)
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 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
- NCT02990403
- Sponsor's protocol ID
- ShanghaiFMIH-0003
- Status last verified
- Dec 2016
- First submitted
- 7 Dec 2016
- Last updated
- 8 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT02990403
- Acronym / sponsor ID
- ShanghaiFMIH-0003
- Conditions
- Recurrent Pregnancy Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 10 Jun 2017 (estimated)
- Study completion
- 22 Dec 2018 (estimated)
- First posted
- 13 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 are going to observe the efficacy of anti-coagulation and immune therapy in the treatment of 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
- 5
| Arm | Type | Receives |
|---|---|---|
| aspirin+LMWH group | Experimental | Drug: Aspirin, Drug: Heparinaspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd |
| aspirin+LMWH+immunoglobulin group | Experimental | Drug: Aspirin, Drug: Heparin, Drug: Immunoglobulinaspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks |
| aspirin+LMWH+prednisone group | Experimental | Drug: Aspirin, Drug: Heparin, Drug: Prednisoneaspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd |
| aspirin+LMWH+IVIG+prednisone group | Experimental | Drug: Aspirin, Drug: Heparin, Drug: Prednisone, Drug: Immunoglobulinaspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd |
| dydrogesterone group | Other | Drug: Dydrogesteronedydrogesterone 20-30mg/day, po, tid |
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 2 miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form.
Key exclusion criteria (7 listed)
- having experienced severe 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.
- having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)
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+LMWH group, aspirin+LMWH+IVIG+prednisone group, aspirin+LMWH+immunoglobulin group, aspirin+LMWH+prednisone group |
| Heparin | Drug | aspirin+LMWH group, aspirin+LMWH+IVIG+prednisone group, aspirin+LMWH+immunoglobulin group, aspirin+LMWH+prednisone group |
| Prednisone | Drug | aspirin+LMWH+IVIG+prednisone group, aspirin+LMWH+prednisone group |
| Immunoglobulin | Drug | aspirin+LMWH+IVIG+prednisone group, aspirin+LMWH+immunoglobulin group |
| Dydrogesterone | Drug | dydrogesterone group |
Primary outcome
live birth
Time frame: through study completion, an average of 3 year
live birth means success pregnancy（more than gestational age of 20 weeks）
3 secondary outcomes
D-dimer
Time frame: through study completion, an average of 3 year
Uterine artery blood flow
Time frame: through study completion, an average of 3 year
human chorionic gonadotropin
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 8 Mar 2017.
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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, Heparin and Prednisone in people 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 7 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 8 Mar 2017. 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?
live birth (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 8 Mar 2017.