Pulmonary EmbolismNCT01524393
Risk of Pulmonary and Venous Thromboembolism in Pregnancies After in Vitro Fertilization
An observational study of Pulmonary Embolism and Venous Thromboembolism, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
Occurrence of venous thromboembolism during in Vitro Fertilization (IVF) pregnancies has been reported in numerous case reports and in two small consecutive series. The incidence of venous thromboembolism (VTE) after IVF has been claimed to be comparable to the incidence of VTE during normal pregnancy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pulmonary Embolism, Venous Thromboembolism
- How many people
- 140,458 participants
- Where
- 1 siteSweden
- Study dates
- Jan 1990to Dec 2010
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All mothers who had given birth to a child.
Who may be able to join
- Exposed women:
- All mothers who had given birth to a child as a result of IVF will be retrieved from the Swedish Medical Birth Register (MBR) at the National Board of Health and Welfare.
- Unexposed women:
- Each IVF woman will be matched with up to 5 unexposed women from the MBR by calendar year of delivery ±2 years and maternal age ±1 year.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of the Risk of Pulmonary Embolism and Venous Thromboembolism in Pregnancy After in Vitro Fertilization.
Occurrence of venous thromboembolism during in Vitro Fertilization (IVF) pregnancies has been reported in numerous case reports and in two small consecutive series. The incidence of venous thromboembolism (VTE) after IVF has been claimed to be comparable to the incidence of VTE during normal pregnancy. No information exists concerning pulmonary embolism (PE).
The aim is to estimate and compare the risk of both PE and VTE during the the different phases of pregnancy after IVF to that in age and period matched control women. The investigators will use the Swedish National Health Registers to estimate the risk.
Read the detailed description
Background: Occurrence of venous thromboembolism (VTE) during IVF pregnancies has been reported in numerous case reports and in two small consecutive series. The incidence of VTE after IVF has been claimed to be comparable to the incidence of VTE during normal pregnancy. No information exists concerning pulmonary embolism (PE).
Aim: The aim is to estimate and compare the risk of both PE and VTE during the trimesters of pregnancy after IVF to that in age and period matched control women.
Design and methods: A cross-sectional study using linkage of Swedish population and health registers. The Swedish National Patient Register encompasses inpatients and outpatients. Inpatient data in Sweden is available nationwide since 1987. Outpatient diagnoses from hospitals started to be collected in 1997. Data in the Patient Register will be linked to the Swedish Medical Birth Register (MBR) at the National Board of Health and Welfare through the unique personal identity number assigned to all Swedish residents, Exposed women: Mothers who had given birth to a child as a result of IVF will be retrieved from the Swedish IVF Register at the National Board of Health and Welfare. The Swedish IVF Register is now a part of the Swedish Medical Birth Register (MBR) at the National Board of Health and Welfare and includes information on IVF pregnancies since 1982.
We will restrict the retrieval to mothers of a child born as from 1990 until 2008 and who had their first child born after assisted reproduction by IVF.
Unexposed women: Each IVF woman will be matched with 5 unexposed women from the MBR by calendar year of delivery and maternal age.
Information will be retrieved on country of birth, pre-pregnancy body mass index, family situation, cigarette smoking habits, number of older siblings, singleton/multiple births, and estimated length of gestation from the MBR register. Dates of the trimesters is calculated from the length of gestation. Women´s education is found in the Register of Education, Statistics Sweden, by linkage through the personal identity number.
Diagnoses of VTE including PE will be found by linkage to the Swedish Patient Register of the National Board of Health and Welfare. This register comprises date of admission and discharge, and main diagnosis with up to seven contributing diagnoses. Diagnoses are recorded according to the International Classification of Diagnoses (ICD), ninth version prior to 1996 and the tenth version from 1997. Codes used were 415B, 451B, 452, 453C-D, 453W, 453X, 673C, 671D-E, 671F in ICD9 and I260, I269, I801- 3, I808-9, I822-3, I828-9, O223, O225, O871, O873, O879, O882 in ICD10.
The study is approved by the Research Ethics Committee of Karolinska Institutet, Stockholm, Sweden (Dnr 2010/267-31/4).
- Conditions
- Pulmonary Embolism, Venous Thromboembolism
- Keywords
- Assisted Reproductive Techniques, Pregnancy, Pulmonary Embolism, Venous Thromboembolism
- Medical subject headings
- Pulmonary Embolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IVF pregnancy | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startJan 1990
- Primary completionDec 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 140,458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Professor Peter Henriksson, Danderyd Hospital
- Investigators
- Anders Ekbom, Professor, Study chair, Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, SwedenPeter Henriksson, Professor, Principal investigator, Division of Cardiovascular Medicine, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, SwedenOuti Hovatta, Professor, Study chair, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524393
- Sponsor's protocol ID
- Dnr 2010/267-31/4
- Status last verified
- Jan 2012
- First submitted
- 28 Jan 2012
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Chan WS, Dixon ME. The "ART" of thromboembolism: a review of assisted reproductive technology and thromboembolic complications. Thromb Res. 2008;121(6):713-26. doi: 10.1016/j.thromres.2007.05.023. Epub 2007 Jul 30.
PubMed 17659766Mara M, Koryntova D, Rezabek K, Kapral A, Drbohlav P, Jirsova S, Zivny J. [Thromboembolic complications in patients undergoing in vitro fertilization: retrospective clinical study]. Ceska Gynekol. 2004 Jul;69(4):312-6. Czech.
PubMed 15369253Henriksson P, Westerlund E, Wallen H, Brandt L, Hovatta O, Ekbom A. Incidence of pulmonary and venous thromboembolism in pregnancies after in vitro fertilisation: cross sectional study. BMJ. 2013 Jan 15;346:e8632. doi: 10.1136/bmj.e8632.
PubMed 23321489
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Risk of Pulmonary Embolism and Venous Thromboembolism in Pregnancy After in Vitro Fertilization.
- ClinicalTrials.gov ID
- NCT01524393
- Acronym / sponsor ID
- Dnr 2010/267-31/4
- Conditions
- Pulmonary Embolism, Venous Thromboembolism
- Keywords
- Assisted Reproductive Techniques, Pregnancy, Pulmonary Embolism, Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140,458 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Jan 1990
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Feb 2012 (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.
Occurrence of venous thromboembolism during in Vitro Fertilization (IVF) pregnancies has been reported in numerous case reports and in two small consecutive series. The incidence of venous thromboembolism (VTE) after IVF has been claimed to be comparable to the incidence of VTE during normal pregnancy. No information exists concerning pulmonary embolism (PE).
The aim is to estimate and compare the risk of both PE and VTE during the the different phases of pregnancy after IVF to that in age and period matched control women. The investigators will use the Swedish National Health Registers to estimate the risk.
Detailed description
Background: Occurrence of venous thromboembolism (VTE) during IVF pregnancies has been reported in numerous case reports and in two small consecutive series. The incidence of VTE after IVF has been claimed to be comparable to the incidence of VTE during normal pregnancy. No information exists concerning pulmonary embolism (PE).
Aim: The aim is to estimate and compare the risk of both PE and VTE during the trimesters of pregnancy after IVF to that in age and period matched control women.
Design and methods: A cross-sectional study using linkage of Swedish population and health registers. The Swedish National Patient Register encompasses inpatients and outpatients. Inpatient data in Sweden is available nationwide since 1987. Outpatient diagnoses from hospitals started to be collected in 1997. Data in the Patient Register will be linked to the Swedish Medical Birth Register (MBR) at the National Board of Health and Welfare through the unique personal identity number assigned to all Swedish residents, Exposed women: Mothers who had given birth to a child as a result of IVF will be retrieved from the Swedish IVF Register at the National Board of Health and Welfare. The Swedish IVF Register is now a part of the Swedish Medical Birth Register (MBR) at the National Board of Health and Welfare and includes information on IVF pregnancies since 1982.
We will restrict the retrieval to mothers of a child born as from 1990 until 2008 and who had their first child born after assisted reproduction by IVF.
Unexposed women: Each IVF woman will be matched with 5 unexposed women from the MBR by calendar year of delivery and maternal age.
Information will be retrieved on country of birth, pre-pregnancy body mass index, family situation, cigarette smoking habits, number of older siblings, singleton/multiple births, and estimated length of gestation from the MBR register. Dates of the trimesters is calculated from the length of gestation. Women´s education is found in the Register of Education, Statistics Sweden, by linkage through the personal identity number.
Diagnoses of VTE including PE will be found by linkage to the Swedish Patient Register of the National Board of Health and Welfare. This register comprises date of admission and discharge, and main diagnosis with up to seven contributing diagnoses. Diagnoses are recorded according to the International Classification of Diagnoses (ICD), ninth version prior to 1996 and the tenth version from 1997. Codes used were 415B, 451B, 452, 453C-D, 453W, 453X, 673C, 671D-E, 671F in ICD9 and I260, I269, I801- 3, I808-9, I822-3, I828-9, O223, O225, O871, O873, O879, O882 in ICD10.
The study is approved by the Research Ethics Committee of Karolinska Institutet, Stockholm, Sweden (Dnr 2010/267-31/4).
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVF pregnancy | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All mothers who had given birth to a child.
Key inclusion criteria (4 listed)
- All mothers who had given birth to a child as a result of IVF will be retrieved from the Swedish Medical Birth Register (MBR) at the National Board of Health and Welfare.
- Each IVF woman will be matched with up to 5 unexposed women from the MBR by calendar year of delivery ±2 years and maternal age ±1 year.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Feb 2012.
- Background: PubMed 17659766Chan WS, Dixon ME. The "ART" of thromboembolism: a review of assisted reproductive technology and thromboembolic complications. Thromb Res. 2008;121(6):713-26. doi: 10.1016/j.thromres.2007.05.023. Epub 2007 Jul 30.
- Background: PubMed 15369253Mara M, Koryntova D, Rezabek K, Kapral A, Drbohlav P, Jirsova S, Zivny J. [Thromboembolic complications in patients undergoing in vitro fertilization: retrospective clinical study]. Ceska Gynekol. 2004 Jul;69(4):312-6. Czech.
- Derived from this study: PubMed 23321489Henriksson P, Westerlund E, Wallen H, Brandt L, Hovatta O, Ekbom A. Incidence of pulmonary and venous thromboembolism in pregnancies after in vitro fertilisation: cross sectional study. BMJ. 2013 Jan 15;346:e8632. doi: 10.1136/bmj.e8632.
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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.
Anders Ekbom, Professor study chair
Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden
Peter Henriksson, Professor principal investigator
Division of Cardiovascular Medicine, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden
Outi Hovatta, Professor study chair
Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Venous Thromboembolism, run by Danderyd Hospital at 1 site in Sweden.
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 4 inclusion and 0 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 2 Feb 2012. 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 Sweden. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01524393, which also lists 3 linked publications.
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 2 Feb 2012.