Recurrent MiscarriagePhase 4NCT02303171
Use of Warfarin After the First Trimester in Pregnant Women With APS
A Phase 4 study testing Enoxaparin and Warfarin in people with Recurrent Miscarriage and Antiphospholipid Syndrome, run by Mohamed Sayed Abdelhafez at 2 sites in Egypt.
Trial summary
Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS) Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Recurrent Miscarriage, Antiphospholipid Syndrome
- What is being tested?
- Enoxaparin and Warfarin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- Nov 2014to Jun 2025
- 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 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women with APS diagnosed according to the revised classification criteria for APS in 2006 in Sydney, Australia
- Early pregnancy body weight is 50-90 Kg
Who cannot join
- Women with systemic lupus erythematosus (SLE)
- Women with active thromboembolic disorders
- Women with history of previous thromboembolic disorders
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
Mohamed I Eid, Dr, +201225401274, dr_moh_eid@yahoo.com
- Recruiting
Private practice settings
Al Mansurah, Dakahlia Governorate
About this study
Official title: Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome
Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)
Read the detailed description
Women will be randomly divided into two groups; one will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy and the other will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester until termination of pregnancy.
- Conditions
- Recurrent Miscarriage, Antiphospholipid Syndrome
- Being tested
- Enoxaparin, Warfarin
- Keywords
- Antiphospholipid syndrome, APS, Warfarin
- Medical subject headings
- Abortion, Habitual, Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Also called Clexan
Women will be given Enoxaparin throughout pregnancy in a dose of 40 mg/day subcutaneously (SC)
WarfarinDrug
Also called Marevan
Women will be given Enoxaparin (40 mg/day SC) in the first trimester then Warfarin (3-5 mg/day) after the first trimester until termination of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin group | Active comparator | Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy Receives: Drug: Enoxaparin |
| Warfarin group | Active comparator | Women will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal loss
Unexplained fetal death of morphologically normal fetus after the first trimester
Measured: From 12 weeks to 42 weeks gestational age
Secondary outcomes (3)
Preterm delivery
Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency
Measured: From 20 weeks to 34 weeks gestational age
Intrauterine growth restriction (IUGR)
Birth weight less than the 10th percentile for gestational age
Measured: At birth
Congenital fetal malformations
Congenital fetal malformations
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent MiscarriageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Sayed Abdelhafez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Sayed Abdelhafez, Mansoura University
- Investigators
- Mohamed I Eid, Dr, Principal investigator, Mansoura UniversityMohamed S Abdelhafez, Dr, Study director, Mansoura UniversityAbdelmageed F Mashaly, Prof, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303171
- Sponsor's protocol ID
- MIE1
- Status last verified
- Oct 2023
- First submitted
- 25 Nov 2014
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.
PubMed 32358837
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome
- ClinicalTrials.gov ID
- NCT02303171
- Acronym / sponsor ID
- MIE1
- Conditions
- Recurrent Miscarriage, Antiphospholipid Syndrome
- Keywords
- Antiphospholipid syndrome, APS, Warfarin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mohamed Sayed AbdelhafezUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 27 Nov 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.
Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)
Detailed description
Women will be randomly divided into two groups; one will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy and the other will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester until termination of pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin group | Active comparator | Drug: EnoxaparinWomen will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy |
| Warfarin group | Active comparator | Drug: WarfarinWomen will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women with APS diagnosed according to the revised classification criteria for APS in 2006 in Sydney, Australia
- Early pregnancy body weight is 50-90 Kg
Key exclusion criteria (3 listed)
- Women with systemic lupus erythematosus (SLE)
- Women with active thromboembolic disorders
- Women with history of previous thromboembolic disorders
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 |
|---|---|---|
| EnoxaparinAlso: ClexanWomen will be given Enoxaparin throughout pregnancy in a dose of 40 mg/day subcutaneously (SC) | Drug | Enoxaparin group |
| WarfarinAlso: MarevanWomen will be given Enoxaparin (40 mg/day SC) in the first trimester then Warfarin (3-5 mg/day) after the first trimester until termination of pregnancy | Drug | Warfarin group |
Primary outcome
Fetal loss
Time frame: From 12 weeks to 42 weeks gestational age
Unexplained fetal death of morphologically normal fetus after the first trimester
3 secondary outcomes
Preterm delivery
Time frame: From 20 weeks to 34 weeks gestational age
Intrauterine growth restriction (IUGR)
Time frame: At birth
Congenital fetal malformations
Time frame: At birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 32358837Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.
- Individual participant dataSharing planned: No
Related trials for Recurrent Miscarriage
Not yet recruitingObservational study
Cervical Length Reference Range at 28-34 Weeks in Singleton Pregnancies
Preterm Birth, Cervical Length
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Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
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Azithromycin for Cerclage Prophylaxis
Cervical Insufficiency
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Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
Preterm Birth Complication, Preterm Birth
Not yet recruitingObservational study
Cohort Study on the Levels of Placental Growth Factor and Nucleosomes in Early Pregnancy and Adverse Pregnancy Outcomes
Preeclampsia, Premature Birth
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.
Mohamed I Eid, Dr principal investigator
Mansoura University
Mohamed S Abdelhafez, Dr study director
Mansoura University
Abdelmageed F Mashaly, Prof study chair
Mansoura University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin and Warfarin in people with Recurrent Miscarriage and Antiphospholipid Syndrome, run by Mohamed Sayed Abdelhafez at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Contact Mohamed I Eid, Dr (+201225401274, dr_moh_eid@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal loss (time frame: From 12 weeks to 42 weeks gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02303171, which also lists 1 linked publication.
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 31 Oct 2023.