Treatment of restriction in fetal growth with L-arginine

Recruiting

• Conditions: Intrauterine growth restriction (IUGR); Pregnancy and Childbirth

• Registration Number: ISRCTN32082979
• Lead Sponsor: Fundación para Formación e Investigación Sanitaria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-12
• Last Update Posted: 14 January 2019
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 130

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.