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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR845 |
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Date of registration:
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18/12/2006 |
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Primary sponsor: |
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Public title:
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MLPA And Karyotyping, an Evaluation (M.A.K.E.).
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Scientific title:
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Prenatal diagnosis: MLPA and/ or karyotyping in amniotic fluid; Diagnostic acurracy, patient outcome en costs. - M.A.K.E. |
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Date of first enrolment:
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1/2/2007 |
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Target sample size:
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4500 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=845 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: Double; Control: Not applicable; Group: [default]; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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J.M.M.
Lith, van |
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Address:
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Onze Lieve Vrouwe Gasthuis (OLVG), Department of Obstetrics and Gynaecology,
P.O. Box 95500, Oosterpark 9
1090 HM
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5993477 |
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Email:
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j.m.m.vanlith@olvg.nl |
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Affiliation:
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Name:
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Elisabeth
Boormans |
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Address:
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Onze Lieve Vrouwe Gasthuis (OLVG), Department of Obstetrics and Gynaecology,
P.O. Box 95500, Oosterpark 9
1090 HM
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5993477 |
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Email:
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e.m.a.boormans@olvg.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Amniocentesis is performed;
2. The referral indication is advanced maternal age and/or increased risk after PNS;
3. Age > or = 18 years;
4. No language barriers;
5. Informed consent is given;
6. Singleton pregnancies.
Exclusion criteria: Other referral indications: parent (s) with chromosome aberration, ultrasound abnormalities, previous child with chromosome aberration.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Fetal aneuploidy, Trisomy 13, Trisomy 18, Trisomy 21, Sex chromosome abnormalities
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Intervention(s)
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Both MLPA and Karyotyping are carried out.
MLPA (multiplex ligation-dependent probe amplification) 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 2-4 days. To perform MLPA 2-4ml 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 (<12ml), MLPA will not be carried out in the study.
Karyotyping is carried out without any changes. The result is known in 2-3 weeks.
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Primary Outcome(s)
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Diagnostic accuracy, technical performance (inconclusive or missing results), technical capacity.
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Secondary Outcome(s)
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Patient anxiety and distress, cost-effectiveness, unexpected findings and patient preference.
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Secondary ID(s)
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80-007029-98-07-047
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ISRCTN47252164
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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