Effects of plasma expanders administration in pregnancies complicated by intra uterine growth restriction

Effects of plasma expanders administration in pregnancies complicated by intra uterine growth restriction - OST07/11

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003730-13-IT

Enrollment

Registered

2012-07-23

Start date

2012-05-22

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

intra uterine growth restriction MedDRA version: 14.1 Level: LLT Classification code 10022819 Term: Intrauterine growth retardation System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions MedDRA version: 14.1 Level: PT Classification code 10061452 Term: Complication of pregnancy System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Trade Name: TETRASPAN*20SAC 500ML 60MG/ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: hydroxyethyl starch (idrossietil amido) Concentration unit: mg/ml milligram(s)/millilitre Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - - Singleton pregnancies - - Pregnancies complicated by intra uterine growth restriction (fetal weight under tenth centile for gestational age and umbilical Doppler impairment, in the form of an increased pulsatility index, absent or reversed diastolic flow) - - IUGR diagnosed between 24th and 32nd week of gestational age - - Age > 18 years - - Acquisition of informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 48 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Maternal pathologies existing prior to pregnancy - - Maternal complications of pregnancy (gestational hypertension, pre-eclampsia, gestational diabetes - - Fetal morphologic abnormalities - - Fetal chromosomal abnormalities - - Maternal-fetal infections - - Placentation abnormalities (placenta previa, vasa previa) - - Metrorrhagia - - Premature rupture of membranes - - Drug abuse, cigarette smoking

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary endpoint of this study is to evaluate, in terms of perinatal morbidity and mortality, the effects of plasma expander administration (hydroxy-methy-starch 30 ml/kg) in pregnancies complicated by intra uterine growth restriction (IUGR) (fetal weight under the tenth centile for gestational age and umbilical Doppler impairment).;Secondary Objective: Gestational age at delivery -- Placental abruption risk -- Time elapsed between IUGR diagnosis and delivery -- Newborns birth weight -- pH (from umbilical artery blood) at birth -- Number of newborns with ultrasound detectable brain alterations. -;Primary end point(s): The primary endpoint of this study is to evaluate, in terms of perinatal morbidity and mortality, the effects of plasma expander administration (hydroxy-methy-starch 30 ml/kg) in pregnancies complicated by intra uterine growth restriction;Timepoint(s) of evaluation of this end point: 16 weeks	—

Measure

Time frame

Main Objective: The primary endpoint of this study is to evaluate, in terms of perinatal morbidity and mortality, the effects of plasma expander administration (hydroxy-methy-starch 30 ml/kg) in pregnancies complicated by intra uterine growth restriction (IUGR) (fetal weight under the tenth centile for gestational age and umbilical Doppler impairment).;Secondary Objective: Gestational age at delivery -- Placental abruption risk -- Time elapsed between IUGR diagnosis and delivery -- Newborns birth weight -- pH (from umbilical artery blood) at birth -- Number of newborns with ultrasound detectable brain alterations. -;Primary end point(s): The primary endpoint of this study is to evaluate, in terms of perinatal morbidity and mortality, the effects of plasma expander administration (hydroxy-methy-starch 30 ml/kg) in pregnancies complicated by intra uterine growth restriction;Timepoint(s) of evaluation of this end point: 16 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Gestational age at delivery - - Placental abruption risk - - Time elapsed between IUGR diagnosis and delivery - - Newborns birth weight - - pH (from umbilical artery blood) at birth - - Number of newborns with ultrasound detectable brain alterations.;Timepoint(s) of evaluation of this end point: 16 weeks	—

Countries

Italy

Contacts

Public ContactU.O. Ostetricia, PI Dr.Ghi

AOU di Bologna Policlinico S.Orsola-Malpighi

tullio.ghi@aosp.bo.it051/6364411

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026