Contact information
Type
Scientific
Primary contact
Ms Elisabeth Boormans
ORCID ID
Contact details
Onze Lieve Vrouwe Gasthuis (OLVG)
Department of Obstetrics and Gynaecology
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
+31 (0)20 599 3477
e.m.a.boormans@olvg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
80-007029-98-07-047
Study information
Scientific title
Acronym
MAKE
Study hypothesis
The present study will evaluate the hypothesised equivalent pre-clinical diagnostic accuracy of Multiplex Ligation-dependent Probe Amplification (MLPA) compared to karyotyping in a clinical setting.
Ethics approval
Approval received from the local ethics committee (Medisch Ethische Toetsings Commissie) on the 21st August 2006 (ref: WO 06.032).
Study design
Prospective study of two paired diagnostic tests.
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Not specified
Trial type
Diagnostic
Patient information sheet
Condition
Trisomy 13, Trisomy 21, Fetal aneuploidies, Trisomy 18, Sex chromosome abnormalities
Intervention
In each patient, amniotic fluid is assessed with MLPA (experimental diagnostic test) and Karyotyping (gold standard).
MPLA:
MLPA is a molecular genetic technique in prenatal diagnosis using amniotic fluid. In this study a commercially available kit, P095 is used (produced by MRC Holland and widely tested).
The MLPA-result is known in two to four days. To perform MLPA 2 - 4 ml of amniotic fluid is required. Such an amount is available since routinely 15 - 20 ml of amniotic fluid is obtained.
If there is too little amniotic fluid (less than 12 ml), MLPA will not be carried out in the study.
Karyotyping:
Karyotyping is carried out without any changes. The result is known in two to three weeks.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Diagnostic accuracy
2. Technical performance (inconclusive or missing results)
3. Technical capacity
Secondary outcome measures
1. Patient anxiety and distress
2. Cost-effectiveness
3. Unexpected findings
4. Patient preference
Overall trial start date
01/02/2007
Overall trial end date
01/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Amniocentesis is performed
2. The referral indication is advanced maternal age and/or increased risk after PreNatal Screening (PNS)
3. Aged more than or equal to 18 years
4. No language barriers
5. Informed consent is given
6. Singleton pregnancies
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
4500 paired MLPA-Karyotyping test results
Participant exclusion criteria
Other referral indications:
1. Parent(s) with chromosome aberration
2. Ultrasound abnormalities
3. Previous child with chromosome aberration
Recruitment start date
01/02/2007
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam
1090 HM
Netherlands
Sponsor information
Organisation
Onze Lieve Vrouwe Gasthuis (OLVG) (The Netherlands)
Sponsor details
Department of Obstetrics and Gynaecology
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18492228
Publication citations
-
Protocol
Boormans EM, Birnie E, Wildschut HI, Schuring-Blom HG, Oepkes D, van Oppen CA, Nijhuis JG, Macville MV, Kooper AJ, Huijsdens K, Hoffer MV, Go A, Creemers J, Bhola SL, Bilardo KM, Suijkerbuijk R, Bouman K, Galjaard RJ, Bonsel GJ, van Lith JM, Multiplex ligation-dependent probe amplification versus karyotyping in prenatal diagnosis: the M.A.K.E. study., BMC Pregnancy Childbirth, 2008, 8, 18, doi: 10.1186/1471-2393-8-18.