IMproved Pregnancy Outcomes by Early Detection; personalised medicine for pregnant women: novel metabolomic and proteomic biomarkers to detect pre-eclampsia and improve outcome.

Completed

Conditions: hypertension in pregnancy
toxemia
10026908
10057166

Registration Number: NL-OMON40138

Lead Sponsor: niversity College Cork, Ireland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1000

Inclusion Criteria

nulliparous women
16 year or older
singleton pregnancy
between 9+0 and 16+6 weeks gestation

Exclusion Criteria

unsure term of pregnancy, 3 or more miscarriages or terminations, known or suspected fetal anomaly, essential hypertension or hypertension at booking, diabetes, renal disease, Systemic Lupus Erythematosus, Anti-phospholipid Syndrome, Sickle Cell Disease, HIV positive, Hepatitis B or C positive, major uterine anomaly, cervical suture in situ, knife cone biopsy, long term steroids, treatment low-dow aspirin/LMVW heparin

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pre-eclampsia<br /><br>Spontaneous pre-term birth<br /><br>Small for gestational age babies</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Early onset pre-eclampsia<br /><br>Multisystem complications of pre-eclampsia<br /><br>Pre-eclampsia with severe fetal or neonatal complications<br /><br><br /><br>Major neonatal morbidity in preterm infants<br /><br>Major neonatal morbidity in term infants<br /><br><br /><br>Pre-eclampsia with severe maternal complications<br /><br>Pre-eclampsia with either severe maternal copmlication or severe fetal or<br /><br>neonatal complications<br /><br><br /><br>Early onset SGA (small for gestational age)<br /><br>SGA (small for gestational age) with severe fetal or neonatal complications<br /><br><br /><br>Early onset spontaneous preterm birth<br /><br>Spontaneous preterm birth with severe fetal or neonatal complications<br /><br>Spontaneous preterm birth with PPROM<br /><br>Spontaneous preterm birth without PPROM</p><br>