Recurrent MiscarriagePhase 4NCT02326051
Timing of Initiation of LMWH Administration in Pregnant Women With APS
A Phase 4 study testing Enoxaparin in people with Recurrent Miscarriage and Antiphospholipid Syndrome, run by Mohamed Sayed Abdelhafez at 2 sites in Egypt.
Trial summary
Evaluation of the effect of altering the timing of initiation of low molecular weight heparin (LMWH) administration on the pregnancy outcomes in 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
- 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
- Dec 2014to May 2017
- 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
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
Private practice settings
Al Mansurah, Dakahlia Governorate
About this study
Official title: Timing of Initiation of Low Molecular Weight Heparin Administration in Pregnant Women With Antiphospholipid Syndrome
Evaluation of the effect of altering the timing of initiation of low molecular weight heparin (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)
Read the detailed description
Women will be randomly divided into two groups; one will start Enoxaparin therapy once positive pregnancy test is established and the other will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation. In all women, Enoxaparin will be given in a dose of 40 mg/day subcutaneously and the therapy will continue until termination of pregnancy
- Conditions
- Recurrent Miscarriage, Antiphospholipid Syndrome
- Being tested
- Enoxaparin
- Keywords
- Antiphospholipid syndrome, APS, LMWH
- 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 start Enoxaparin therapy in a dose of 40 mg/day subcutaneously once positive pregnancy test is established and the therapy will continue until termination of pregnancy
EnoxaparinDrug
Also called Clexan
Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously after sonographic confirmation of fetal cardiac pulsation and the therapy will continue until termination of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Early Enoxaparin initiation | Active comparator | Women will start Enoxaparin therapy once positive pregnancy test is established Receives: Drug: Enoxaparin |
| Later Enoxaparin initiation | Active comparator | Women will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women
Measured: After 12 weeks gestational age
Secondary outcomes (4)
Fetal loss
Unexplained fetal death of morphologically normal fetus after the first trimester
Measured: From 20 weeks to 42 weeks gestational age
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
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 posted25 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
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 UniversityWaleed El-refaie, Dr, Study director, Mansoura UniversityAhmed El-Zayadi, Dr, Study director, Mansoura UniversityAhmed Badawy, Prof, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326051
- Sponsor's protocol ID
- MIE2
- Status last verified
- Nov 2017
- First submitted
- 22 Dec 2014
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Initiation of Low Molecular Weight Heparin Administration in Pregnant Women With Antiphospholipid Syndrome
- ClinicalTrials.gov ID
- NCT02326051
- Acronym / sponsor ID
- MIE2
- Conditions
- Recurrent Miscarriage, Antiphospholipid Syndrome
- Keywords
- Antiphospholipid syndrome, APS, LMWH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mohamed Sayed AbdelhafezUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 25 Dec 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 the effect of altering the timing of initiation of low molecular weight heparin (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)
Detailed description
Women will be randomly divided into two groups; one will start Enoxaparin therapy once positive pregnancy test is established and the other will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation. In all women, Enoxaparin will be given in a dose of 40 mg/day subcutaneously and the therapy will continue until termination of pregnancy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Enoxaparin initiation | Active comparator | Drug: EnoxaparinWomen will start Enoxaparin therapy once positive pregnancy test is established |
| Later Enoxaparin initiation | Active comparator | Drug: EnoxaparinWomen will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation |
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 start Enoxaparin therapy in a dose of 40 mg/day subcutaneously once positive pregnancy test is established and the therapy will continue until termination of pregnancy | Drug | Early Enoxaparin initiation |
| EnoxaparinAlso: ClexanWomen will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously after sonographic confirmation of fetal cardiac pulsation and the therapy will continue until termination of pregnancy | Drug | Later Enoxaparin initiation |
Primary outcome
Ongoing pregnancy rate
Time frame: After 12 weeks gestational age
Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women
4 secondary outcomes
Fetal loss
Time frame: From 20 weeks to 42 weeks gestational age
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
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 29 Nov 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Recurrent Miscarriage
Not yet recruitingObservational study
Cervical Length Reference Range at 28-34 Weeks in Singleton Pregnancies
Preterm Birth, Cervical Length
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
Not yet recruitingPhase 4
Azithromycin for Cerclage Prophylaxis
Cervical Insufficiency
Not yet recruiting
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
Waleed El-refaie, Dr study director
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 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: finished, as of the sponsor's last update on 29 Nov 2017. 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?
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.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: After 12 weeks gestational age). 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 29 Nov 2017.