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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31920

Enrollment

Registered

2008-09-18

Start date

2008-07-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

intrauterine growth restriction small for gestational age

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary study parameters: Size and growth of the Crown-rump length and the gestational sac, doppler of the artery uterina Secondary outcomes are small for gestational age, defined as p140/90 mmHg measured twice six hours apart and proteinuria (> 0.3g in 24 hour urine collection)	—

Countries

Netherlands

Outcome results