Serious adverse events according to treatment arm
. | Nadroparin and medical surveillance . | Medical surveillance alone . |
---|---|---|
Pregnancy complications other than end point | ||
Miscarriage* | 1 | 0 |
Termination† | 0 | 2 |
Gestational diabetes | 0 | 2 |
Gestational hypertension | 4 | 6 |
Cholestasis | 3 | 1 |
Premature rupture of membranes | 3 | 3 |
Oligohydramnios | 4 | 3 |
Placenta previa | 1 | 1 |
Risk of preterm delivery | 4 | 2 |
Abnormal uterine artery velocimetry | 14 | 12 |
Others‡ | 1 | 2 |
Other maternal adverse events | ||
Bleeding | 1 | 2 |
Thrombocytopenia | 0 | 0 |
Others§ | 5 | 0 |
Fetal/neonatal adverse events | ||
Chromosomal or congenital abnormalities‖ | 0 | 2 |
Abnormal cardiotocography | 0 | 1 |
Others¶ | 1 | 1 |
. | Nadroparin and medical surveillance . | Medical surveillance alone . |
---|---|---|
Pregnancy complications other than end point | ||
Miscarriage* | 1 | 0 |
Termination† | 0 | 2 |
Gestational diabetes | 0 | 2 |
Gestational hypertension | 4 | 6 |
Cholestasis | 3 | 1 |
Premature rupture of membranes | 3 | 3 |
Oligohydramnios | 4 | 3 |
Placenta previa | 1 | 1 |
Risk of preterm delivery | 4 | 2 |
Abnormal uterine artery velocimetry | 14 | 12 |
Others‡ | 1 | 2 |
Other maternal adverse events | ||
Bleeding | 1 | 2 |
Thrombocytopenia | 0 | 0 |
Others§ | 5 | 0 |
Fetal/neonatal adverse events | ||
Chromosomal or congenital abnormalities‖ | 0 | 2 |
Abnormal cardiotocography | 0 | 1 |
Others¶ | 1 | 1 |
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.