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Incidence of Pregnancies and Births With Spina Bifida in Denmark in 2008-2014

NCT02685813 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 350000

Last updated 2016-03-08

No results posted yet for this study

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 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.

Conditions

  • Spina Bifida

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Olav B. Petersen, MD, ph.d · Aarhus University Hospital

  • Mikkel M. Rasmussen, MD, ph.d · Aarhus University Hospital

  • Charlotte R. Bodin, Bsc.med · Aarhus University Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-11-30
Completion
2017-01-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02685813 on ClinicalTrials.gov