MLPA And Karyotyping, an Evaluation (M.A.K.E.).

Prenatal diagnosis: MLPA and/ or karyotyping in amniotic fluid; Diagnostic acurracy, patient outcome en costs.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28597

Enrollment

4500

Registered

2006-12-18

Start date

2007-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MLPA can detect Down syndrome, trisomies 13, 18

Interventions

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 commerci

Eligibility

Inclusion criteria

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

Exclusion criteria: Other referral indications: parent (s) with chromosome aberration, ultrasound abnormalities, previous child with chromosome aberration.

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy, technical performance (inconclusive or missing results), technical capacity.	—

Secondary

Measure	Time frame
Patient anxiety and distress, cost-effectiveness, unexpected findings and patient preference.	—

Contacts

Public ContactElisabeth Boormans

Onze Lieve Vrouwe Gasthuis (OLVG), Department of Obstetrics and Gynaecology, P.O. Box 95500

e.m.a.boormans@olvg.nl+31 (0)20 5993477

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)