PregnancyNCT01100697
Outcome of Fetal Spina Bifida
An observational study of Pregnancy and Fetal and Neonatal Health, run by University of Luebeck at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 weeks to 12 years
- Conditions the study is for
- Pregnancy, Fetal and Neonatal Health
- How many people
- 103 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to 1 Oct 2015
- 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 12 weeks to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Fetuses with spina bifida identified at prenatal ultrasound examination between 1993 and 2009
Who may be able to join
- spina bifida identified at prenatal ultrasound examination
- ultrasound diagnosis between 1993 - 2009
Who cannot join
- deviant postnatal diagnosis
- loss to follow-up
- incomplete data
Trial locations and contacts
1 site in 1 country.
Germany1 site
Schleswig- Holstein University, Campus Lübeck, Department of Prenatal Medicine
Lübeck, Schleswig-Holstein, D- 23538
About this study
Official title: 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.
Read more
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.
- Conditions
- Pregnancy, Fetal and Neonatal Health
- Keywords
- prenatal diagnosis, ultrasound, outcome, spina bifida, neural tube defect
- Medical subject headings
- Spinal Dysraphism, Neural Tube Defects
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
pregnancy outcome
To investigate the prenatal course and functional outcome of fetuses with spina bifida according to prenatal ultrasound exam.
Measured: 17 yrs
Infant psychomotor development
Kaufmann ABC
Denver Developmental Screening Test
walking ability
muscle strenght
Measured: 17 yrs
Infant bladder and bowel function
Degree of continence.
Measured: 17 yrs
Secondary outcomes (2)
Conception date
Measured: 17 yrs
spectrum of ultrasound signs
Measured: 17yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startDec 2009
- Primary completionOct 2014
- Study completion1 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Alexander Beyer, University of Luebeck
- Investigators
- Feriel Amari, M.D., Principal investigator, Schleswig- Holstein University, LübeckJan Weichert, M.D., Study director, Schleswig- Holstein University, LübeckKlaus Diedrich, PhD, Study chair, Schleswig- Holstein University, Lübeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100697
- Sponsor's protocol ID
- UKSH-HL-09-181
- Status last verified
- May 2018
- First submitted
- 2 Apr 2010
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cameron M, Moran P. Prenatal screening and diagnosis of neural tube defects. Prenat Diagn. 2009 Apr;29(4):402-11. doi: 10.1002/pd.2250.
PubMed 19301349D'Addario V, Rossi AC, Pinto V, Pintucci A, Di Cagno L. Comparison of six sonographic signs in the prenatal diagnosis of spina bifida. J Perinat Med. 2008;36(4):330-4. doi: 10.1515/JPM.2008.052.
PubMed 18598123Biggio JR Jr, Owen J, Wenstrom KD, Oakes WJ. Can prenatal ultrasound findings predict ambulatory status in fetuses with open spina bifida? Am J Obstet Gynecol. 2001 Nov;185(5):1016-20. doi: 10.1067/mob.2001.117676.
PubMed 11717624Peralta CF, Bunduki V, Plese JP, Figueiredo EG, Miguelez J, Zugaib M. Association between prenatal sonographic findings and post-natal outcomes in 30 cases of isolated spina bifida aperta. Prenat Diagn. 2003 Apr;23(4):311-4. doi: 10.1002/pd.584.
PubMed 12673636Beyer DA, Diedrich K, Weichert J, Kavallaris A, Amari F. Seasonality of spina bifida in Northern Germany. Arch Gynecol Obstet. 2011 Oct;284(4):849-54. doi: 10.1007/s00404-010-1762-0. Epub 2010 Nov 16.
PubMed 21079979
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Spina Bifida -Prenatal Course and Outcome in 103 Cases A Single Center Experience.
- ClinicalTrials.gov ID
- NCT01100697
- Acronym / sponsor ID
- UKSH-HL-09-181
- Conditions
- Pregnancy, Fetal and Neonatal Health
- Keywords
- prenatal diagnosis, ultrasound, outcome, spina bifida, neural tube defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- 1 Oct 2015 (actual)
- First posted
- 9 Apr 2010 (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 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 weeks to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Fetuses with spina bifida identified at prenatal ultrasound examination between 1993 and 2009
Key inclusion criteria (2 listed)
- spina bifida identified at prenatal ultrasound examination
- ultrasound diagnosis between 1993 - 2009
Key exclusion criteria (3 listed)
- deviant postnatal diagnosis
- loss to follow-up
- incomplete data
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
pregnancy outcome
Time frame: 17 yrs
To investigate the prenatal course and functional outcome of fetuses with spina bifida according to prenatal ultrasound exam.
Infant psychomotor development
Time frame: 17 yrs
Kaufmann ABC Denver Developmental Screening Test walking ability muscle strenght
Infant bladder and bowel function
Time frame: 17 yrs
Degree of continence.
2 secondary outcomes
Conception date
Time frame: 17 yrs
spectrum of ultrasound signs
Time frame: 17yrs
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 3 May 2018.
- Background: PubMed 19301349Cameron M, Moran P. Prenatal screening and diagnosis of neural tube defects. Prenat Diagn. 2009 Apr;29(4):402-11. doi: 10.1002/pd.2250.
- Background: PubMed 18598123D'Addario V, Rossi AC, Pinto V, Pintucci A, Di Cagno L. Comparison of six sonographic signs in the prenatal diagnosis of spina bifida. J Perinat Med. 2008;36(4):330-4. doi: 10.1515/JPM.2008.052.
- Background: PubMed 11717624Biggio JR Jr, Owen J, Wenstrom KD, Oakes WJ. Can prenatal ultrasound findings predict ambulatory status in fetuses with open spina bifida? Am J Obstet Gynecol. 2001 Nov;185(5):1016-20. doi: 10.1067/mob.2001.117676.
- Background: PubMed 12673636Peralta CF, Bunduki V, Plese JP, Figueiredo EG, Miguelez J, Zugaib M. Association between prenatal sonographic findings and post-natal outcomes in 30 cases of isolated spina bifida aperta. Prenat Diagn. 2003 Apr;23(4):311-4. doi: 10.1002/pd.584.
- Derived from this study: PubMed 21079979Beyer DA, Diedrich K, Weichert J, Kavallaris A, Amari F. Seasonality of spina bifida in Northern Germany. Arch Gynecol Obstet. 2011 Oct;284(4):849-54. doi: 10.1007/s00404-010-1762-0. Epub 2010 Nov 16.
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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.
Feriel Amari, M.D. principal investigator
Schleswig- Holstein University, Lübeck
Jan Weichert, M.D. study director
Schleswig- Holstein University, Lübeck
Klaus Diedrich, PhD study chair
Schleswig- Holstein University, Lübeck
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 Pregnancy and Fetal and Neonatal Health, run by University of Luebeck at 1 site in Germany.
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 2 inclusion and 3 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 3 May 2018. 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 Germany. 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.
What does the primary outcome measure?
pregnancy outcome (time frame: 17 yrs). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01100697, which also lists 5 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 3 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.