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

NCT02685813 | Unknown

• 1 other identifier: SpinaBifida2016
• Study Type: observational
• Target: 350,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ultra sound; birth defects

Outcome Measures

Primary Outcomes (1)

• incidence of spina bifida

  8 years

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Pregnant women, participating in prenatal screening

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Department of Gynecology and Obstetrics, Aarhus university Hospital

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Spinal Dysraphism; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Olav B. Petersen, MD, ph.d

  Aarhus University Hospital

  STUDY DIRECTOR

• Mikkel M. Rasmussen, MD, ph.d

  Aarhus University Hospital

  STUDY CHAIR

• Charlotte R. Bodin, Bsc.med

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte R. Bodin

CONTACT

+4523658003; chbodi@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical and research year student

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 19, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: March 8, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)