PregnancyPhase 4NCT01917799
Aspirin, Heparin and Miscarriage
A Phase 4 study testing Aspirin and Heparin in people with Pregnancy and Miscarriage, run by University of Khartoum at 1 site in Libya.
Trial summary
Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in patients with a history of recurrent miscarriages. Read more about this study
- Who is it for?
- Ages 15 to 48 years, women only
- Conditions the study is for
- Pregnancy, Miscarriage
- What is being tested?
- Aspirin and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteLibya
- Study dates
- Jan 2009to Dec 2013
- 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 15 to 48 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women
- History of 2 or more of miscarriage
Who cannot join
- Twins
Trial locations and contacts
1 site in 1 country.
Libya1 site, 1 recruiting
- Recruiting
Misurata Teaching Hospital
Misratah, Misratah, 218
Mohamed O Elmahashi, MD, +249911259199, essadifathi@hotmail.com
Bashir M Ashur, MD, +249911259199, bmashur@yahoo.com
About this study
Official title: Low Dose Aspirin and Low-molecular-weight Heparin in the Treatment of Pregnant Libyan Women With Recurrent Miscarriage
Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in patients with a history of recurrent miscarriages.
- Conditions
- Pregnancy, Miscarriage
- Being tested
- Aspirin, Heparin
- Keywords
- Aspirin, Heparin, pregnancy, miscarriage
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called LDA
75mg tab of LDA once daily for 7 months
HeparinDrug
Also called Enoxaparin
0.4 mL/day of the Enoxaparin
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | 75mg tab of aspirin once daily Receives: Drug: Aspirin |
| Aspirin + heparin | Active comparator | 75mg tab of aspirin once daily + 0.4 mL/day of injection of low molecular weight heparin Receives: Drug: Aspirin; Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of miscarriages
To compare number of miscarriages between the two groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startJan 2009
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (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 PregnancyStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Khartoum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ishag Adam, University of Khartoum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917799
- Sponsor's protocol ID
- LDA and LMWH
- Status last verified
- Aug 2013
- First submitted
- 31 Jul 2013
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Elmahashi MO, Elbareg AM, Essadi FM, Ashur BM, Adam I. Low dose aspirin and low-molecular-weight heparin in the treatment of pregnant Libyan women with recurrent miscarriage. BMC Res Notes. 2014 Jan 9;7:23. doi: 10.1186/1756-0500-7-23.
PubMed 24405979
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Aspirin and Low-molecular-weight Heparin in the Treatment of Pregnant Libyan Women With Recurrent Miscarriage
- ClinicalTrials.gov ID
- NCT01917799
- Acronym / sponsor ID
- LDA and LMWH
- Conditions
- Pregnancy, Miscarriage
- Keywords
- Aspirin, Heparin, pregnancy, miscarriage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of KhartoumUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 7 Aug 2013 (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.
Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in patients with a history of recurrent miscarriages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: Aspirin75mg tab of aspirin once daily |
| Aspirin + heparin | Active comparator | Drug: Aspirin, Drug: Heparin75mg tab of aspirin once daily + 0.4 mL/day of injection of low molecular weight heparin |
Who may qualify
- Ages
- 15 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pregnant women
- History of 2 or more of miscarriage
Key exclusion criteria (1 listed)
- Twins
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 |
|---|---|---|
| AspirinAlso: LDA75mg tab of LDA once daily for 7 months | Drug | Aspirin, Aspirin + heparin |
| HeparinAlso: Enoxaparin0.4 mL/day of the Enoxaparin | Drug | Aspirin + heparin |
Primary outcome
Number of miscarriages
Time frame: 3 months
To compare number of miscarriages between the two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Derived from this study: PubMed 24405979Elmahashi MO, Elbareg AM, Essadi FM, Ashur BM, Adam I. Low dose aspirin and low-molecular-weight heparin in the treatment of pregnant Libyan women with recurrent miscarriage. BMC Res Notes. 2014 Jan 9;7:23. doi: 10.1186/1756-0500-7-23.
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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.
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 Pregnancy and Miscarriage, run by University of Khartoum at 1 site in Libya.
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 1 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 7 Aug 2013. 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 Libya. 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?
Number of miscarriages (time frame: 3 months). 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 NCT01917799, 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 7 Aug 2013.