Cardiac- and vascular disease (-abnormalities) as underlying cause of premature birth.

Cardiac- and vascular disease (-abnormalities) as underlying cause of premature birth. - PRELHUDE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39237

Enrollment

300

Registered

2012-01-31

Start date

2012-12-13

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

premature birth

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women who deliver prematurely for unknown reasons

Exclusion criteria

Exclusion criteria: HIV positive, patients with congenital heart disease, multiple pregnancies, uterine anomalies, congenital/chromosomal anomalies.

Design outcomes

Primary

Measure	Time frame
The determine if (subclinical) congenital heart disease (CHD) is present in women with idiopathic premature delivery. As there is no data on the prevalence of this in the general population, if we find CHD in our study population we will additionally seek METC approval to study the prevalence in women who deliver at term after an uncomplicated pregnancy. To estblish the presence, nature and molecular basis of vascular pathology in placenta and placenta-bed of women with idiopathic premature delivery. Control samples are being collected from women who deliver by casearean section at term (PANDA-postnataal project, door de AMC METC positief beoordeeld op 24 augustus 2010 METC 10/128 # 10.17.1418corr). The myometrium biopsies acquired after c section will be used as control samples for the molecular analysis on myometrium biopsies acquired from women with congenital heart disease who deliver prematurely (the ZAHARA3 study). Maternal and umbilical cord blood will be used to determine levels of biomarkers putatively relevant for premature delivery	—

Measure

Time frame

The determine if (subclinical) congenital heart disease (CHD) is present in women with idiopathic premature delivery. As there is no data on the prevalence of this in the general population, if we find CHD in our study population we will additionally seek METC approval to study the prevalence in women who deliver at term after an uncomplicated pregnancy. To estblish the presence, nature and molecular basis of vascular pathology in placenta and placenta-bed of women with idiopathic premature delivery. Control samples are being collected from women who deliver by casearean section at term (PANDA-postnataal project, door de AMC METC positief beoordeeld op 24 augustus 2010 METC 10/128 # 10.17.1418corr). The myometrium biopsies acquired after c section will be used as control samples for the molecular analysis on myometrium biopsies acquired from women with congenital heart disease who deliver prematurely (the ZAHARA3 study). Maternal and umbilical cord blood will be used to determine levels of biomarkers putatively relevant for premature delivery

—

Secondary

Measure	Time frame
None	—

Countries

Netherlands

Outcome results