Pregnancy LossNCT06484634
Role of Low-Molecular-Weight Heparin in Unexplained Recurrent Pregnancy Loss
A study testing Low molecular weight heparin in people with Pregnancy Loss, run by RESnTEC, Institute of Research at 1 site in Pakistan.
Trial summary
Using low-molecular-weight heparin (LMWH), outcomes such as live birth rate and the occurrence of pregnancy complications are some of the variables reported in some studies, with varying degrees of success. The present study aimed to compare the role of LMWH in unexplained recurrent pregnancy loss. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Pregnancy Loss
- What is being tested?
- Low molecular weight heparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 31 May 2024
- Phase
- Interventional
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant females between 18 and 44 years of age
- Gestational age above 8 weeks
- A history of ≥3 consecutive first trimester pregnancy losses
Who cannot join
- Patients with systemic lupus erythematosus
- Positive IgG and IgM anticardiolipin antibodies
- Positive for thrombophilia screening
- Any platelet function abnormality or a previous thromboembolic event requiring anticoagulant therapy (including heparin, aspirin or warfarin)
- Sensitive to acetylsalicylic acid, heparin, or warfarin
- Patients with any genetic, anatomical, or hormonal cause of recurrent pregnancy loss
Trial locations and contacts
1 site in 1 country.
About this study
Using low-molecular-weight heparin (LMWH), outcomes such as live birth rate and the occurrence of pregnancy complications are some of the variables reported in some studies, with varying degrees of success. The present study aimed to compare the role of LMWH in unexplained recurrent pregnancy loss.
- Conditions
- Pregnancy Loss
- Being tested
- Low molecular weight heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low molecular weight heparinDrug
A daily dose of 40 mg of low-molecular-weight heparin (LMWH) subcutaneously was given to the patients.
| Study group | Role | What they receive |
|---|---|---|
| LMWH Group | Experimental | Women received a daily dose of 40 mg of Low Molecular Weight Heparin subcutaneously. Receives: Drug: Low molecular weight heparin |
| Control | No intervention | Women received the placebo in the form of a multivitamin tablet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Low-Molecular-Weight Heparin
Efficacy was labeled as yes in terms of live births after the age of viability, i.e., 24 weeks of gestation.
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Dec 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- RESnTEC, Institute of Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484634
- Sponsor's protocol ID
- LMWHDGKHAN
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared with other researchers on a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Low-Molecular-Weight Heparin in Unexplained Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT06484634
- Acronym / sponsor ID
- LMWHDGKHAN
- Conditions
- Pregnancy Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- RESnTEC, Institute of ResearchUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 3 Jul 2024 (actual)
- 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.
Using low-molecular-weight heparin (LMWH), outcomes such as live birth rate and the occurrence of pregnancy complications are some of the variables reported in some studies, with varying degrees of success. The present study aimed to compare the role of LMWH in unexplained recurrent pregnancy loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMWH Group | Experimental | Drug: Low molecular weight heparinWomen received a daily dose of 40 mg of Low Molecular Weight Heparin subcutaneously. |
| Control | No intervention | –Women received the placebo in the form of a multivitamin tablet. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant females between 18 and 44 years of age
- Gestational age above 8 weeks
- A history of ≥3 consecutive first trimester pregnancy losses
Key exclusion criteria (6 listed)
- Patients with systemic lupus erythematosus
- Positive IgG and IgM anticardiolipin antibodies
- Positive for thrombophilia screening
- Any platelet function abnormality or a previous thromboembolic event requiring anticoagulant therapy (including heparin, aspirin or warfarin)
- Sensitive to acetylsalicylic acid, heparin, or warfarin
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 |
|---|---|---|
| Low molecular weight heparinA daily dose of 40 mg of low-molecular-weight heparin (LMWH) subcutaneously was given to the patients. | Drug | LMWH Group |
Primary outcome
Efficacy of Low-Molecular-Weight Heparin
Time frame: 32 weeks
Efficacy was labeled as yes in terms of live births after the age of viability, i.e., 24 weeks of gestation.
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 3 Jul 2024.
- Individual participant dataSharing planned: No. Data can be shared with other researchers on a reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low molecular weight heparin in people with Pregnancy Loss, run by RESnTEC, Institute of Research at 1 site in Pakistan.
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 3 inclusion and 6 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 3 Jul 2024. 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 Pakistan. 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.
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?
Efficacy of Low-Molecular-Weight Heparin (time frame: 32 weeks). 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 3 Jul 2024.