Intrauterine growth restriction (IUGR) Pregnancy and Childbirth
Conditions
Interventions
Pregnant women with an ultrasonographic diagnosis of IUGR will be invited to participate in the study. After signing informed consent, women will be randomised and assigned to one of two study groups
Sponsors
Fundación para Formación e Investigación Sanitaria
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Single pregnancy 3. Ultrasonographic diagnosis of IUGR: estimated fetal weight lower than the 10th percentile for gestational age according to local or national reference values, independently of the results of the Doppler parameters of the umbilical, middle cerebral and/or uterine arteries 4. Live fetuses at 11 and 13 at weeks gestation 6. Gestational age between 24 and 32 weeks 7. No indication of imminent or planned birth 8. Availability to participate in the study and sign the consent
Exclusion criteria
Exclusion criteria: 1. Women with medical complications such as preeclampsia, chronic hypertension, kidney disease, diabetes mellitus, liver dysfunction, autoimmune disease or other significant medical complications 2. Women with a history of major mental disorders (schizophrenia, manic-depressive illness) 3. Women in labor or with imminent or planned delivery 4. Fetal malformation 5. Acute fetal distress 6. IUGR associated with infectious disease 7. Multiple pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Birth weight below the 10th percentile for gestational age and sex, according to local reference curves. The estimation of fetal weight is made by combining the cephalic perimeter, abdominal perimeter and femur length. This weight estimation is usually done every two weeks when the estimated fetal weight percentile is between the 3rd and 10th percentile and each week when it is below the 3th percentile. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives will be analyzed at the postnatal level, except for the diagnosis of the development of hypertension in pregnancy, either preeclampsia or gestational hypertension: 1. Birth weight 2. Gestational age at birth 3. Size of the newborn 4. Abdominal perimeter of the newborn 5. Cephalic perimeter of the newborn 6. Weight index of the newborn 7. Placental weight 8. Placental weight/weight ratio of the newborn 9. Low weight (<2500 g) 10. Very low weight (<1500 g) 11. Preterm delivery <37 weeks of gestation 12. Preterm delivery <32 weeks gestation 13. Preterm delivery <28 weeks gestation 14. Apgar score at minute 1 and 5 15. Perinatal mortality (early fetal and neonatal mortality) 16. Respiratory distress syndrome 17. Bronchopulmonary dysplasia 18. Intraventricular hemorrhage 19. Periventricular leukomalacia (selene) 20. Neonatal sepsis 21. Necrotizing enterocolitis 22. Retinopathy of prematurity 23. Compound of perinatal morbi-mortality 24. Admission to the neonatal intensive care unit 25. Congenital malformations 26. Induction of labor 27. Cesarean section 28. Preeclampsia 29. Gestational hypertension 30. Antepartum hemorrhage 31. Postpartum hemorrhage 32. Maternal infection 33. Need for maternal hospitalization 34. Maternal adverse effects | — |
Countries
Spain
Contacts
Public ContactCatalina De Paco Matallana
Outcome results
None listed