Use of Warfarin After the First Trimester in Pregnant Women With APS
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ClinicalTrials.gov Identifier: NCT02303171 |
Recruitment Status :
Recruiting
First Posted : November 27, 2014
Last Update Posted : October 4, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recurrent Miscarriage Antiphospholipid Syndrome | Drug: Enoxaparin Drug: Warfarin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome |
Study Start Date : | November 2014 |
Estimated Primary Completion Date : | January 2020 |
Estimated Study Completion Date : | July 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Enoxaparin group
Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy
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Drug: Enoxaparin
Women will be given Enoxaparin throughout pregnancy in a dose of 40 mg/day subcutaneously (SC)
Other Name: Clexan |
Active Comparator: Warfarin group
Women will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester
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Drug: Warfarin
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
Other Name: Marevan |
- Fetal loss [ Time Frame: From 12 weeks to 42 weeks gestational age ]Unexplained fetal death of morphologically normal fetus after the first trimester
- Preterm delivery [ Time Frame: From 20 weeks to 34 weeks gestational age ]Delivery of morphologically normal fetus before 34 weeks of gestation due to severe preeclampsia or placental insufficiency
- Intrauterine growth restriction (IUGR) [ Time Frame: At birth ]Birth weight less than the 10th percentile for gestational age
- Congenital fetal malformations [ Time Frame: At birth ]
- Hemorrhagic complications [ Time Frame: After 12 weeks gestational age up to birth ]
- Thromboembolic complications [ Time Frame: After 12 weeks gestational age up to birth ]

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Ages Eligible for Study: | 20 Years to 38 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Women with systemic lupus erythematosus (SLE)
- Women with active thromboembolic disorders
- Women with history of previous thromboembolic disorders

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303171
Contact: Mohamed I Eid, Dr | +201225401274 | dr_moh_eid@yahoo.com |
Egypt | |
Obstetrics and Gynecology Department in Mansoura University Hospital | Recruiting |
Mansourah, Dakahlia, Egypt, 35111 | |
Contact: Mohamed I Eid, Dr +201225401274 dr_moh_eid@yahoo.com | |
Private practice settings | Recruiting |
Mansourah, Dakahlia, Egypt |
Principal Investigator: | Mohamed I Eid, Dr | Mansoura University | |
Study Director: | Mohamed S Abdelhafez, Dr | Mansoura University | |
Study Chair: | Ahmed M Badawy, Prof | Mansoura University | |
Study Chair: | Abdelmageed F Mashaly, Prof | Mansoura University |
Responsible Party: | Mohamed Sayed Abdelhafez, Dr, Mansoura University |
ClinicalTrials.gov Identifier: | NCT02303171 History of Changes |
Other Study ID Numbers: |
MIE1 |
First Posted: | November 27, 2014 Key Record Dates |
Last Update Posted: | October 4, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Antiphospholipid syndrome APS Warfarin |
Warfarin Abortion, Spontaneous Abortion, Habitual Antiphospholipid Syndrome Syndrome Disease |
Pathologic Processes Pregnancy Complications Autoimmune Diseases Immune System Diseases Anticoagulants |