Condition category
Not Applicable
Date applied
22/01/2007
Date assigned
22/01/2007
Last edited
03/06/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.makestudy.nl

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 measures

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

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

http://www.olvg.nl/

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

Results - basic reporting

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18492228

Publication citations

  1. 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.

Additional files

Editorial Notes