Spina BifidaNCT02685813
Incidence of Pregnancies and Births With Spina Bifida in Denmark in 2008-2014
An observational study of Spina Bifida, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Neural tube defects cover a group of severe embryo malformations such as anencephaly and spina bifida. The most severe forms of spina bifida causes numerous disabilities that demand lifelong treatment by a team consisting of primarily neurosurgeons, pediatricians, obstetricians, pediatric neurologists, pediatric… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spina Bifida
- How many people
- 350,000 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to Jan 2017
- How long will I take part?
- 1 Year
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: FØTOdatabasen is a national fetal medicine database, which includes information on maternal characteristics: age, parity, BMI, ethnicity, smoking status, diabetes status (from 2014), and on the pregnancy: mode of conception, result of first trimester risk assessment for chromosomal anomalies, biometric data, ICD10-codes for any prenatally diagnosed malformation. It links data regarding each pregnancy with postnatal outcome received from the Danish Cytogenetic Registry, the National Patient Registry and the National Birth Registry. FØTOdatabasen includes >95% of all pregnancies in Denmark with due date from 1. January 2008 and onwards. The data completeness is high, with missing data <1% for pregnancy outcome, <1% for smoking status, and <3% for mode of conception
Who may be able to join
- Pregnant women, participating in prenatal screening
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Gynecology and Obstetrics, Aarhus university Hospital
Aarhus N, 8200
Charlotte Bodin, bsc.med, +4523658003, chbodi@rm.dk
Olav B Petersen, ph.d, +4578453322, olavpete@rm.dk
About this study
Neural tube defects cover a group of severe embryo malformations such as anencephaly and spina bifida. The most severe forms of spina bifida causes numerous disabilities that demand lifelong treatment by a team consisting of primarily neurosurgeons, pediatricians, obstetricians, pediatric neurologists, pediatric urologists, gastroenterologists, psychologists and social workers. The disabilities involve morbidity such as decreased motor and sensory function caudal to the lesion, hydrocephalus, scoliosis, bladder and bowel incontinence as well as increased mortality.
In 2004, the Danish Health Authorities introduced new guidelines for fetal diagnostics. These represented a change of paradigm stating that all pregnant women should be offered a prenatal examination including an ultra sound scan in week 12-13 of gestation (including risk estimation of chromosomal diseases) as well as in week 19 of gestation (scanning primarily for malformations). The examination program was not elaborated to eradicate diseases but to support the reproductive autonomy of the pregnant women, including the possibility to seek for termination of the pregnancy in the case of severe disease in the fetus.
Read more
Severe spina bifida is one of the malformations that can be diagnosed with the ultra sound scan in week 19, and since the implementation of the new guidelines from the Danish Health Authority a study by this research group has shown decreased birth incidence at least in the Western part of Denmark.
It is still unknown what has caused this decrease as is the exact number of pregnancies and births complicated by spina bifida in the child; similarly it is unclear whether this decline is a regional or if it is only a Danish phenomenon.
By extraction of data from the Danish Fetal Database ("FØTOdatabasen") which includes information of all 60.000 pregnancies in Denmark annually, the purpose of this register study is to investigate the incidence of pregnancies complicated by prenatal diagnosis of spina bifida in Denmark from 2008 and on, as well as the pregnancy outcome in these cases (including termination of pregnancy). Furthermore results will be compared to results obtained by collaborative partners in Sweden and hopefully also in Saudi Arabia.
Read the detailed description
Hypotheses:
The number of pregnancies in Denmark complicated by spina bifida in the child is constant, but the number of births in Denmark complicated by spina bifida in the child has declined, likely because the mother in most cases chooses to terminate the pregnancy in case of the diagnosis of severe spina bifida at the 19 week ultrasound scan.
Denmark is the only country in the world with a registered decline in the number of newborns with severe spina bifida.
Purpose:
- Investigate the incidence of pregnancies complicated by prenatal diagnosis of spina bifida in Denmark from 2008 and on, as well as the pregnancy outcome in these cases (including termination of pregnancy).
- In cooperation with international partners compare data from Denmark and Sweden (partner in Sweden: Eleonor Tiblad, MD, Ph.D, Center for Fetal Medicine, Karolinska University Hospital) and if possible also Saudi Arabia (partner in the Saudi Arabia collaboration: Marianne Juhler, MD, DMSc, Professor, Rigshospitalet, Denmark and Daniele Rigamonti, MD, professor, Chief of Staff, Department of Neurosurgery, John Hopkins University Hospital Aramco Health Care, Baltimore, USA)
Methods:
Regarding 1): Extraction of data from the Danish Fetal Database ("FØTOdatabasen") which includes information of all 60.000 pregnancies in Denmark annually.
Regarding 2): Data comparable to those collected in this study are expected to be delivered from collaborative partners in Sweden and Saudi Arabia. Comparison analysis of the data from our collaborative partners in Sweden and Saudi Arabia in order to discover differences in spina bifida pregnancy management on an international level.
Data from Saudi Arabia and Sweden:
The investigators will ask their partners in Sweden and Saudi Arabia to provide institutional, regional or national data comparable to those obtained in Denmark. Data from each pregnancy will then be compared on the following parameters:
- Prenatal diagnosis of spina bifida/MMC (ICD10: Q050-059)
- Pregnancy outcome: live birth, stillbirth, intrauterine death, spontaneous abortion, termination of pregnancy, fetal reduction in twin pregnancies
- Gestational age at outcome
- Epidemiological details of the cohort offered prenatal diagnostics (population based, institution based, population size
- Consultation guidelines and possibilities when spina bifida is diagnosed prenatally
The Danish Fetal Database:
FØTOdatabasen is a national fetal medicine database. The database includes information on maternal characteristics: age, parity, BMI, ethnicity, smoking status, Diabetes status (from 2014), and on the pregnancy: mode of conception, result of first trimester risk assessment for chromosomal anomalies, biometric data, ICD10-codes for any prenatally diagnosed malformation. FØTOdatabasen receives this information automatically on a daily basis from all birth departments' prenatal database (Astraia), and links data regarding each pregnancy with postnatal outcome from the Danish Cytogenetic Registry, the National Patient Registry and the National Birth Registry. FØTOdatabasen includes >95% of all pregnancies in Denmark with due date from 1. January 2008 and onwards. The data completeness is high, with missing data <1% for pregnancy outcome, <1% for smoking status, and <3% for mode of conception.
The database thereby provides a unique possibility to analyze population based data from approximately 55.0000 pregnancies annually with prenatal diagnosis and postnatal outcome. On an international level FØTOdatabasen thereby provides unique data to analyze pregnancies with spina bifida in a population and the pregnancy outcome, including live born children, intrauterine deaths and spontaneous as well as termination of pregnancy. Hereby it can be estimated how many incidences of spina bifida are isolated or associated with other malformations.
- Conditions
- Spina Bifida
- Keywords
- Ultra sound, birth defects
- Medical subject headings
- Spinal Dysraphism, Congenital Abnormalities
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 |
|---|---|---|
| Pregnant women in Denmark | Pregnant women in Denmark participating in prenatal screening. This counts for approximately 50000 pregnancies/year and covers >95% of all pregnancies nationally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of spina bifida
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 350,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Charlotte Rosenkrantz Bodin, Aarhus University Hospital
- Investigators
- Olav B. Petersen, MD, ph.d, Study director, Aarhus University HospitalMikkel M. Rasmussen, MD, ph.d, Study chair, Aarhus University HospitalCharlotte R. Bodin, Bsc.med, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685813
- Sponsor's protocol ID
- SpinaBifida2016
- Status last verified
- Mar 2016
- First submitted
- 11 Feb 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Pregnancies and Births With Spina Bifida in Denmark in 2008-2014
- ClinicalTrials.gov ID
- NCT02685813
- Acronym / sponsor ID
- SpinaBifida2016
- Conditions
- Spina Bifida
- Keywords
- Ultra sound, birth defects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350,000 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- Feb 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 19 Feb 2016 (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.
Neural tube defects cover a group of severe embryo malformations such as anencephaly and spina bifida. The most severe forms of spina bifida causes numerous disabilities that demand lifelong treatment by a team consisting of primarily neurosurgeons, pediatricians, obstetricians, pediatric neurologists, pediatric urologists, gastroenterologists, psychologists and social workers. The disabilities involve morbidity such as decreased motor and sensory function caudal to the lesion, hydrocephalus, scoliosis, bladder and bowel incontinence as well as increased mortality.
In 2004, the Danish Health Authorities introduced new guidelines for fetal diagnostics. These represented a change of paradigm stating that all pregnant women should be offered a prenatal examination including an ultra sound scan in week 12-13 of gestation (including risk estimation of chromosomal diseases) as well as in week 19 of gestation (scanning primarily for malformations). The examination program was not elaborated to eradicate diseases but to support the reproductive autonomy of the pregnant women, including the possibility to seek for termination of the pregnancy in the case of severe disease in the fetus.
Severe spina bifida is one of the malformations that can be diagnosed with the ultra sound scan in week 19, and since the implementation of the new guidelines from the Danish Health Authority a study by this research group has shown decreased birth incidence at least in the Western part of Denmark.
It is still unknown what has caused this decrease as is the exact number of pregnancies and births complicated by spina bifida in the child; similarly it is unclear whether this decline is a regional or if it is only a Danish phenomenon.
By extraction of data from the Danish Fetal Database ("FØTOdatabasen") which includes information of all 60.000 pregnancies in Denmark annually, the purpose of this register study is to investigate the incidence of pregnancies complicated by prenatal diagnosis of spina bifida in Denmark from 2008 and on, as well as the pregnancy outcome in these cases (including termination of pregnancy). Furthermore results will be compared to results obtained by collaborative partners in Sweden and hopefully also in Saudi Arabia.
Detailed description
Hypotheses:
The number of pregnancies in Denmark complicated by spina bifida in the child is constant, but the number of births in Denmark complicated by spina bifida in the child has declined, likely because the mother in most cases chooses to terminate the pregnancy in case of the diagnosis of severe spina bifida at the 19 week ultrasound scan.
Denmark is the only country in the world with a registered decline in the number of newborns with severe spina bifida.
Purpose:
- Investigate the incidence of pregnancies complicated by prenatal diagnosis of spina bifida in Denmark from 2008 and on, as well as the pregnancy outcome in these cases (including termination of pregnancy).
- In cooperation with international partners compare data from Denmark and Sweden (partner in Sweden: Eleonor Tiblad, MD, Ph.D, Center for Fetal Medicine, Karolinska University Hospital) and if possible also Saudi Arabia (partner in the Saudi Arabia collaboration: Marianne Juhler, MD, DMSc, Professor, Rigshospitalet, Denmark and Daniele Rigamonti, MD, professor, Chief of Staff, Department of Neurosurgery, John Hopkins University Hospital Aramco Health Care, Baltimore, USA)
Methods:
Regarding 1): Extraction of data from the Danish Fetal Database ("FØTOdatabasen") which includes information of all 60.000 pregnancies in Denmark annually.
Regarding 2): Data comparable to those collected in this study are expected to be delivered from collaborative partners in Sweden and Saudi Arabia. Comparison analysis of the data from our collaborative partners in Sweden and Saudi Arabia in order to discover differences in spina bifida pregnancy management on an international level.
Data from Saudi Arabia and Sweden:
The investigators will ask their partners in Sweden and Saudi Arabia to provide institutional, regional or national data comparable to those obtained in Denmark. Data from each pregnancy will then be compared on the following parameters:
- Prenatal diagnosis of spina bifida/MMC (ICD10: Q050-059)
- Pregnancy outcome: live birth, stillbirth, intrauterine death, spontaneous abortion, termination of pregnancy, fetal reduction in twin pregnancies
- Gestational age at outcome
- Epidemiological details of the cohort offered prenatal diagnostics (population based, institution based, population size
- Consultation guidelines and possibilities when spina bifida is diagnosed prenatally
The Danish Fetal Database:
FØTOdatabasen is a national fetal medicine database. The database includes information on maternal characteristics: age, parity, BMI, ethnicity, smoking status, Diabetes status (from 2014), and on the pregnancy: mode of conception, result of first trimester risk assessment for chromosomal anomalies, biometric data, ICD10-codes for any prenatally diagnosed malformation. FØTOdatabasen receives this information automatically on a daily basis from all birth departments' prenatal database (Astraia), and links data regarding each pregnancy with postnatal outcome from the Danish Cytogenetic Registry, the National Patient Registry and the National Birth Registry. FØTOdatabasen includes >95% of all pregnancies in Denmark with due date from 1. January 2008 and onwards. The data completeness is high, with missing data <1% for pregnancy outcome, <1% for smoking status, and <3% for mode of conception.
The database thereby provides a unique possibility to analyze population based data from approximately 55.0000 pregnancies annually with prenatal diagnosis and postnatal outcome. On an international level FØTOdatabasen thereby provides unique data to analyze pregnancies with spina bifida in a population and the pregnancy outcome, including live born children, intrauterine deaths and spontaneous as well as termination of pregnancy. Hereby it can be estimated how many incidences of spina bifida are isolated or associated with other malformations.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women in Denmark | – | –Pregnant women in Denmark participating in prenatal screening. This counts for approximately 50000 pregnancies/year and covers >95% of all pregnancies nationally. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- FØTOdatabasen is a national fetal medicine database, which includes information on maternal characteristics: age, parity, BMI, ethnicity, smoking status, diabetes status (from 2014), and on the pregnancy: mode of conception, result of first trimester risk assessment for chromosomal anomalies, biometric data, ICD10-codes for any prenatally diagnosed malformation. It links data regarding each pregnancy with postnatal outcome received from the Danish Cytogenetic Registry, the National Patient Registry and the National Birth Registry. FØTOdatabasen includes >95% of all pregnancies in Denmark with due date from 1. January 2008 and onwards. The data completeness is high, with missing data <1% for pregnancy outcome, <1% for smoking status, and <3% for mode of conception
Key inclusion criteria (1 listed)
- Pregnant women, participating in prenatal screening
Key exclusion criteria (1 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
incidence of spina bifida
Time frame: 8 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Individual participant dataSharing planned: Yes
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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.
Olav B. Petersen, MD, ph.d study director
Aarhus University Hospital
Mikkel M. Rasmussen, MD, ph.d study chair
Aarhus University Hospital
Charlotte R. Bodin, Bsc.med principal investigator
Aarhus University Hospital
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 Spina Bifida, run by Aarhus University Hospital at 1 site 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 1 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 8 Mar 2016. 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 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.
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?
Contact Charlotte R. Bodin (+4523658003, chbodi@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of spina bifida (time frame: 8 years). 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 8 Mar 2016.