Multiplex ligation-dependent probe amplification And Karyotyping: an Evaluation
| ISRCTN | ISRCTN47252164 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47252164 |
| Secondary identifying numbers | 80-007029-98-07-047 |
- Submission date
- 22/01/2007
- Registration date
- 22/01/2007
- Last edited
- 03/06/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Elisabeth Boormans
Scientific
Scientific
Onze Lieve Vrouwe Gasthuis (OLVG)
Department of Obstetrics and Gynaecology
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
| Phone | +31 (0)20 599 3477 |
|---|---|
| e.m.a.boormans@olvg.nl |
Study information
| Study design | Prospective study of two paired diagnostic tests. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Not specified |
| Study type | Diagnostic |
| Scientific title | |
| Study acronym | MAKE |
| Study objectives | 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(s) | Approval received from the local ethics committee (Medisch Ethische Toetsings Commissie) on the 21st August 2006 (ref: WO 06.032). |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/02/2007 |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 4500 paired MLPA-Karyotyping test results |
| Key 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 |
| Key exclusion criteria | Other referral indications: 1. Parent(s) with chromosome aberration 2. Ultrasound abnormalities 3. Previous child with chromosome aberration |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam
1090 HM
Netherlands
1090 HM
Netherlands
Sponsor information
Onze Lieve Vrouwe Gasthuis (OLVG) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Obstetrics and Gynaecology
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
| Website | http://www.olvg.nl/ |
|---|---|
"ROR" |
https://ror.org/01d02sf11 |
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 20/05/2008 | Yes | No |
