Skip to content

LOFA

LOFA – LOngitudinal cell-Free dnA characteristics in pregnancy - LOFA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57894
Enrollment
363
Registered
2025-02-07
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

placenta insufficiency, preterm birth, placenta mosacisms

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: in order to be eligible to participate in this study, a subject must meet all of the following criteria:   Pregnant>18 yearsSingleton pregnancyGestational age > 24 weeksBirth at the Wilhelmina’s Children HospitalAnd for the placenta-related complications or imminent preterm labor must meet one of the definitions below:  PIH:Diastolic blood pressure >90 mmHg and/or systolic >140 mmHg, measured twice with a minimum interval of 6 hours  Preeclampsia:PIH with proteinuria (EKR > 30 mg/mol) OR PIH with organ dysfunction including kidney dysfunction (creatinine > 90 umol/L), liver damage, neurological symptoms or hematologic abnormalities OR PIH with FGR  HELLP:Hemolysis, liver function abnormalities and thrombocytopenia  FGR:Estimated fetal weight (EFW) and/or abdominal circumference (AC) <p10  PPROM:Positive fern test and/or clinical diagnosis (e.g. objectified fluid loss/oligohydramnios)Cervix shortening:Cervix length < 2.5cm

Exclusion criteria

Exclusion criteria: - Confirmed fetal chromosomal abnormalities - Fetal infections (e.g. CMV) - Multifetal pregnancy - No informed consent - Fetal structural anomalie

Design outcomes

Primary

MeasureTime frame
Adverse Pregnancy and birth outcomes/complications in relation to cfDNA characteristics in the second half of pregnancy

Secondary

MeasureTime frame
- Neonatal morbidity/mortality - Severity of maternal disease - Duration until delivery (i.e. pregnancy complication-delivery interval) - Added value of cfDNA characteristics other than fetal fraction - Added value of cfRNA characteristics

Countries

Netherlands

Contacts

Public ContactM.N. Bekker

Universitair Medisch Centrum Utrecht

m.n.bekker-3@umcutrecht.nl0887554010

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)