Prediction of early onset intra uterine growth retardation using morphologic and endocrine placental parameters.

Conditions: intrauterine growth restriction
small for gestational age
10010273

Registration Number: NL-OMON31920

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Women, with a singleton ongoing pregnancy between 4 till 8 weeks gestational age, for both study and control population will be included.
Cases: Women with a previous early onset IUGR (needing delivery before 34 weeks gestational age). In which the IUGR was caused by placental factors and not by infection or congenital disorders. The birth weight must be under the 5th percentile for its gestational age and combined with ultrasonographic signs of an elevated pulsity index of the umbilical cord or an absence or reversed end-diastolic flow.
Controls: At least parity 1, with a previous uncomplicated pregnancy

Exclusion Criteria

Multiple pregnancy for both study and control population. Nulliparous women. Women with pre-existing hypertension, diabetes mellitus, systemic diseases, kidney diseases. If a women does not want to be informed whether a physical defect is revealed by the sonography then she will be excluded for this study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters: Placental vascularisation as described in the<br /><br>protocol, placental volume/ growth, placental serum markers (PAPP-A, PlGF,<br /><br>PP-12, PAI, Ang-2, sFlt and Seng)<br /><br><br /><br>The main outcome: IUGR.<br /><br>IUGR is defined as a birth weight percentile p < 5 and a Pulsity Index (PI) of<br /><br>the umbilical artery p > 95 or absent of end-diastolic flow of the umbilical<br /><br>artery. IUGR will be divided into Very Severe IUGR needing delivery before 28<br /><br>weeks gestational age, Early Onset IUGR needing delivery before 34 weeks<br /><br>gestational age and Late Onset IUGR needing delivery after 34 weeks gestational<br /><br>age. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters: Size and growth of the Crown-rump length and the<br /><br>gestational sac, doppler of the artery uterina<br /><br><br /><br>Secondary outcomes are small for gestational age, defined as p<10 for<br /><br>gestational age, and preeclampsia, defined as blood pressure >140/90 mmHg<br /><br>measured twice six hours apart and proteinuria (> 0.3g in 24 hour urine<br /><br>collection)</p><br>