Table 3

Serious adverse events according to treatment arm

Nadroparin and medical surveillanceMedical surveillance alone
Pregnancy complications other than end point   
    Miscarriage* 
    Termination 
    Gestational diabetes 
    Gestational hypertension 
    Cholestasis 
    Premature rupture of membranes 
    Oligohydramnios 
    Placenta previa 
    Risk of preterm delivery 
    Abnormal uterine artery velocimetry 14 12 
    Others 
Other maternal adverse events   
    Bleeding 
    Thrombocytopenia 
    Others§ 
Fetal/neonatal adverse events   
    Chromosomal or congenital abnormalities 
    Abnormal cardiotocography 
    Others 
Nadroparin and medical surveillanceMedical surveillance alone
Pregnancy complications other than end point   
    Miscarriage* 
    Termination 
    Gestational diabetes 
    Gestational hypertension 
    Cholestasis 
    Premature rupture of membranes 
    Oligohydramnios 
    Placenta previa 
    Risk of preterm delivery 
    Abnormal uterine artery velocimetry 14 12 
    Others 
Other maternal adverse events   
    Bleeding 
    Thrombocytopenia 
    Others§ 
Fetal/neonatal adverse events   
    Chromosomal or congenital abnormalities 
    Abnormal cardiotocography 
    Others 
*

Miscarriage was defined as fetal loss occurring within the 15th gestational week.

Terminations were at the 18th gestational week for chromosomal abnormality (trisomy 18) and at the 19th gestational week for fetal malformations (severe dextrocardia and diaphragmatic hernia).

Uterine contractions in 1 treated and 1 nontreated woman, and renal pelvic dilatation in 1 nontreated women.

§

Headache in 3 women, epigastralgia in 1 woman, and dyspnea in 1 woman.

Described for terminations.

Cystic fibrosis in 1 treated woman and jaundice in 1 nontreated woman.

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