Outcome of Fetal Spina Bifida

May 2, 2018 updated by: Daniel Alexander Beyer, University of Luebeck

Fetal Spina Bifida -Prenatal Course and Outcome in 103 Cases A Single Center Experience.

Neural tube defects are one of the most prevalent congenital abnormalities, surpassed only by cardiac malformations. Spina bifida accounts for the majority of the neural tube defects and is comprised of a wide spectrum of anomalies ranging from small isolated sacral dysraphisms to large spinal defects. The origin of spina bifida is a failure of neurulation. It usually occurs at 15 days post-conception, resulting in a bony spinal defect with extrusion of the neural placode and/or the meninges outside of the spinal canal. Spina bifida has a prevalence of 1-5 in 1,000 live births and is the most complex congenital abnormality compatible to long-time survival. Concerning psychomotor development as well as urinary bladder and intestinal morbidity the prognosis ranges from normal functional outcome to severe disability.

The diagnosis of serious fetal abnormalities such as spinal dysraphism by ultrasound screening allows patients to prepare for the birth of an impaired child or to consider termination of the pregnancy. In current practice, prenatal counseling and obstetric management depend not only on the detection of a spinal dysraphism but also on an appropriate assessment of the severity of the defect and its possible impact on the postnatal development of the affected child.

Level and type of lesion, presence of associated anomalies (e.g., Chiari II malformation and ventriculomegaly) and mode of surgical closure are factors known to have prognostic impact on the postnatal outcome. Previous studies reported that postnatally determined lesion levels correlated well with functional status and survival. On the contrary, it is still not clear whether similar data obtained antenatally are of value.

In this study, the investigators will review their database of all cases of prenatally diagnosed spina bifida within a 16 year period between 1993 and 2009. By analyzing the prenatal and postnatal characteristics of fetuses with spina bifida in relation to the anatomic level of the lesion, the investigators aim to contribute further information regarding the natural course of affected pregnancies and the correlation of prenatal ultrasound findings with their functional outcome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig- Holstein
      • Lübeck, Schleswig- Holstein, Germany, D- 23538
        • Schleswig- Holstein University, Campus Lübeck, Department of Prenatal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Fetuses with spina bifida identified at prenatal ultrasound examination between 1993 and 2009

Description

Inclusion Criteria:

  • spina bifida identified at prenatal ultrasound examination
  • ultrasound diagnosis between 1993 - 2009

Exclusion Criteria:

  • deviant postnatal diagnosis
  • loss to follow-up
  • incomplete data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
thoracal lesion
spinal lesion at thoracal level detected at prenatal ultrasound exam
lumbar lesion
spinal lesion at lumbar level detected at prenatal ultrasound exam
sacral lesion
spinal lesion at sacral level detected at prenatal ultrasound exam

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pregnancy outcome
Time Frame: 17 yrs
To investigate the prenatal course and functional outcome of fetuses with spina bifida according to prenatal ultrasound exam.
17 yrs
Infant psychomotor development
Time Frame: 17 yrs

Kaufmann ABC

Denver Developmental Screening Test

walking ability

muscle strenght
17 yrs
Infant bladder and bowel function
Time Frame: 17 yrs
Degree of continence.
17 yrs

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Conception date
Time Frame: 17 yrs
17 yrs
spectrum of ultrasound signs
Time Frame: 17yrs
17yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Luebeck

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Feriel Amari, M.D., Schleswig- Holstein University, Lübeck
  • Study Director: Jan Weichert, M.D., Schleswig- Holstein University, Lübeck
  • Study Chair: Klaus Diedrich, PhD, Schleswig- Holstein University, Lübeck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UKSH-HL-09-181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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