Fetal Growth RetardationPhase 4IUGRNCT01390051
Can Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?
A Phase 4 study testing Innohep (Tinzaparin) and tinzaparin in people with Fetal Growth Retardation, run by University of Aarhus at 3 sites in Denmark.
Trial summary
The purpose of the study is to investigate if treatment with an anticoagulant drug increases birth weight in pregnancies complicated by fetal growth restriction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- Innohep (Tinzaparin) and tinzaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesDenmark
- Study dates
- Jul 2011to Jul 2016
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton pregnancy
- IUGR shown by ultrasonography:
- Can understand and read Danish
Who cannot join
- Age below 18 years
- Pregestational weight < 90 kilograms
- Not able to give informed consent
- Chronic kidney disease with creatinine >150 μmol/l
- Chronic hypertension with blood pressure >140/90 mmHg
- Diabetes mellitus; type 1 or 2 or gestational diabetes
Show all 19Show fewer
- Inflammatory bowel disease
- Severe heart disease (including mechanical heart valves)
- Drug or alcohol abuse
- Known coagulopathy (von Willebrand disease, thrombocytopenia, carrier of haemophilia)
- Treatment with vitamin K antagonists
- Known allergy to low LMWH
- Previous heparin-induced thrombocytopenia (HIT (type II))
- Clinically significant bleeding within the last month
- Women with indication for prophylactic treatment with LMWH during pregnancy e.g. previous thromboembolic disease or serious types of thrombophilia (deficiency of antithrombin, protein C or protein S)
- Chromosome anomaly in the child
- Severe malformations in the child
- Contraindication to Innohep®
- Gestational week > 32 weeks
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Consultant phD professor Anne-Mette Hvas
Aarhus, Central Jutland, 8200
Department of Obstetrics
Herning, 7400
Department of Obstetrics
Randers
About this study
Official title: Can Treatment With Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?
The purpose of the study is to investigate if treatment with an anticoagulant drug increases birth weight in pregnancies complicated by fetal growth restriction.
Read the detailed description
Clinical purpose:
- To examine whether treatment with low molecular weight heparin in pregnant women with Intrauterine Growth Restriction (IUGR)increases the birth weight of the child. Our hypothesis is that an increased birth weight leads to reduced morbidity and mortality among these children.
Laboratory purposes:
- To evaluate three new methods to monitor the effect of LMWH.
- To investigate if 2 biochemical markers are positive predictors of IUGR IUGR is defined as a foetus that grows less than expected. IUGR is estimated to occur in up to 5% of all pregnancies, and IUGR is the second most common cause of perinatal morbidity and mortality. Thus, 75% of all stillbirths are caused by IUGR. IUGR is diagnosed by ultrasonography. In IUGR the uteroplacental blood flow is often compromised resulting in foetal growth restriction.
Design: The study is a prospective randomised study where pregnant women with suspected severe IUGR are randomised either to treatment with Innohep® or no treatment. Half of the women receive Innohep® and half of the women do not receive treatment.
Endpoints The primary endpoint is the difference in birth weight in children born of women receiving Innohep® during pregnancy and children born of women who have not received Innohep® during pregnancy
- Conditions
- Fetal Growth Retardation
- Being tested
- Innohep (Tinzaparin), tinzaparin
- Keywords
- birth weight, thrombosis, anticoagulant therapy
- Medical subject headings
- Fetal Growth Retardation, Birth Weight, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innohep (Tinzaparin)Drug
Also called Innohep
Dose: 4,500 IU daily in half of the study populationrandomised to treatment
tinzaparinDrug
Also called Innohep
Dose 4,500 IE daily
| Study group | Role | What they receive |
|---|---|---|
| Innohep | Active comparator | Tinzaparin 4500 I.U. sub cutaneous once daily until gestational week 37 Receives: Drug: Innohep (Tinzaparin); Drug: tinzaparin |
| no treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
birth weight
We compare birth weight in children born of women from the 2 study arms
Measured: Birth weight registered at birth
Secondary outcomes (1)
maternal morbidity
Measured: Comorbidity registered up to one year after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, LEO Pharma
- Responsible party
- Sponsor
- Investigators
- Anne-Mette Hvas, PhD, professor, Principal investigator, Department of Clinical Biochemistry, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390051
- Sponsor's protocol ID
- M-20110042
- Acronym
- IUGR
- Status last verified
- Jul 2016
- First submitted
- 6 Jul 2011
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Treatment With Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?
- ClinicalTrials.gov ID
- NCT01390051
- Acronym / sponsor ID
- IUGR / M-20110042
- Conditions
- Fetal Growth Retardation
- Keywords
- birth weight, thrombosis, anticoagulant therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, LEO Pharma
- Study start
- Jul 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 8 Jul 2011 (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.
The purpose of the study is to investigate if treatment with an anticoagulant drug increases birth weight in pregnancies complicated by fetal growth restriction.
Detailed description
Clinical purpose:
- To examine whether treatment with low molecular weight heparin in pregnant women with Intrauterine Growth Restriction (IUGR)increases the birth weight of the child. Our hypothesis is that an increased birth weight leads to reduced morbidity and mortality among these children.
Laboratory purposes:
- To evaluate three new methods to monitor the effect of LMWH.
- To investigate if 2 biochemical markers are positive predictors of IUGR IUGR is defined as a foetus that grows less than expected. IUGR is estimated to occur in up to 5% of all pregnancies, and IUGR is the second most common cause of perinatal morbidity and mortality. Thus, 75% of all stillbirths are caused by IUGR. IUGR is diagnosed by ultrasonography. In IUGR the uteroplacental blood flow is often compromised resulting in foetal growth restriction.
Design: The study is a prospective randomised study where pregnant women with suspected severe IUGR are randomised either to treatment with Innohep® or no treatment. Half of the women receive Innohep® and half of the women do not receive treatment.
Endpoints The primary endpoint is the difference in birth weight in children born of women receiving Innohep® during pregnancy and children born of women who have not received Innohep® during pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Innohep | Active comparator | Drug: Innohep (Tinzaparin), Drug: tinzaparinTinzaparin 4500 I.U. sub cutaneous once daily until gestational week 37 |
| no treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Singleton pregnancy
- IUGR shown by ultrasonography:
- Can understand and read Danish
Key exclusion criteria (19 listed)
- Age below 18 years
- Pregestational weight < 90 kilograms
- Not able to give informed consent
- Chronic kidney disease with creatinine >150 μmol/l
- Chronic hypertension with blood pressure >140/90 mmHg
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 |
|---|---|---|
| Innohep (Tinzaparin)Also: InnohepDose: 4,500 IU daily in half of the study populationrandomised to treatment | Drug | Innohep |
| tinzaparinAlso: InnohepDose 4,500 IE daily | Drug | Innohep |
Primary outcome
birth weight
Time frame: Birth weight registered at birth
We compare birth weight in children born of women from the 2 study arms
1 secondary outcome
maternal morbidity
Time frame: Comorbidity registered up to one year after 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 18 Aug 2016.
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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.
Anne-Mette Hvas, PhD, professor principal investigator
Department of Clinical Biochemistry, Aarhus University Hospital, Denmark
3 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 Innohep (Tinzaparin) and tinzaparin in people with Fetal Growth Retardation, run by University of Aarhus at 3 sites in Denmark.
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 19 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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
birth weight (time frame: Birth weight registered at birth). 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 18 Aug 2016.