Clinical Trial Results:
Kan behandling med lavmolekylært heparin under graviditet med intrauterin væksthæmning øge fostervæksten?
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Summary
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EudraCT number |
2011-000818-20 |
Trial protocol |
DK |
Global end of trial date |
30 Dec 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Dec 2020
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First version publication date |
27 Dec 2020
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
2009/318
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Aarhus University Hospital
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Sponsor organisation address |
palle Juul-jensens Boulevard 99, Aarhus N, Denmark, 8200
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Public contact |
Anette Tarp Hansen, Aarhus University Hospital
, anette.tarp.hansen@dadlnet.dk
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Scientific contact |
Anette Tarp Hansen, Aarhus University Hospital
, anette.tarp.hansen@dadlnet.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Dec 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Dec 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Dec 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Fødselsvægt/Birth weight
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Protection of trial subjects |
Monitoring by center for Good Clinical Practice, Aarhus University Hospital.
Upon first injection of active drug, study participants stayed 30 minutes for taking care of hypothetical allergic reactions.
Control of platelets 14 days after randomisation to exclude heparin induced thrombocytopenia
Plasma creatinine measured upon inclusion to exlude renal impairment
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Nov 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 53
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Worldwide total number of subjects |
53
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EEA total number of subjects |
53
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
53
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Inclusion criteria: 1. Singleton pregnancy 2. FGR: Estimated fetal weigth is -22 % of expected or increased resistance in the uter-ine arteries: pulsatility index>1.7. 3. Can understand and read Danish | |||||||||
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Pre-assignment
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Screening details |
Inclusion criteria: 1. Singleton pregnancy 2. FGR: Estimated fetal weigth is -22 % of expected or increased resistance in the uter-ine arteries: pulsatility index>1.7. 3. Can understand and read Danish | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
53 | |||||||||
Number of subjects completed |
53 | |||||||||
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Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment arm | |||||||||
Arm description |
Tinzaparin 4,500 IE daily subcutaneously until 37 gestational weeks or delivery | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Innohep
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Innohep 4,500 IE once daily dose subcutaneously
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Arm title
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No treatment | |||||||||
Arm description |
No intervention | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Treatment arm
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Reporting group description |
Tinzaparin 4,500 IE daily subcutaneously until 37 gestational weeks or delivery | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
No treatment
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Reporting group description |
No intervention | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment arm
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Reporting group description |
Tinzaparin 4,500 IE daily subcutaneously until 37 gestational weeks or delivery | ||
Reporting group title |
No treatment
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Reporting group description |
No intervention | ||
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End point title |
Birth weight [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At delivery
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The statistical analysis are described in the published paper (please follow the attached link) |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Birthweight % of expected [2] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At delivery
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The statistical analysis are described in the published paper (please follow the attached link) |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Average fetal growth rate [3] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The measurable unit is really a growth rate, e.g., grams/week as measured from baseline to delivery.
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The statistical analysis are described in the published paper (please follow the attached link) |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Every second week from randomisation until date of delivery
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
13
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: We observed no non-serious or serious adverse events related to the trial or trial drug. in the linked published paper, we describe adverse events not related to the trial and trial drug. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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11 Jun 2014 |
Adding of additional study center for improving the number of elligible patients |
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13 Jan 2016 |
Change of data sources |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/30114561 |
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