Tinzaparin for the treatment of foetal growth retardation: An open-labelled randomized clinical trial.
Thromb Res
; 170: 38-44, 2018 10.
Article
en En
| MEDLINE
| ID: mdl-30114561
ABSTRACT
OBJECTIVE:
Foetal growth retardation (FGR) is a leading cause of perinatal death and long-term harms at survivors. Placental infarction plays a role in FGR, yet, no trials have evaluated whether low molecular weight heparins increase birth weight in ongoing FGR pregnancies.METHODS:
An open-labelled randomized trial in Denmark during 2011-2016, including singleton pregnant women with FGR (estimated foetal weightâ¯<â¯2.3 percentile) diagnosed before gestational weeks 32. Participants were randomly assigned using sealed, blinded envelopes 11 to tinzaparin (4500â¯IU daily until 37 gestational weeks) or no tinzaparin. The primary outcomes were the observed birthweight relative to the expected for gestational age and gender, and foetal growth rates in the two trial groups evaluated by an intention to treat analysis.RESULTS:
We enrolled 53 women. The mean gestational age was 261â¯days in the tinzaparin group and 246â¯days in the no treatment group. The mean birth weight was 2229â¯g in the tinzaparin group compared to 1968â¯g in the no treatment group. However, the birth weight relative to the expected from gestational age and gender was only 2.5 percentage points higher in the tinzaparin group [-5.1 to 10.0] (pâ¯=â¯0.51). The foetal growth rate during follow-up was 124â¯g/week in the tinzaparin group and 119â¯g/week in the no treatment group, a difference of 5â¯g/week [-19 to 29] (pâ¯=â¯0.67). Two perinatal deaths both occurred in the no treatment group.CONCLUSION:
We found no evidence of a tinzaparin effect on the foetal growth rate or the birth weight after adjustment for gestational age.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Retardo del Crecimiento Fetal
/
Tinzaparina
/
Anticoagulantes
Tipo de estudio:
Clinical_trials
Límite:
Female
/
Humans
/
Male
Idioma:
En
Revista:
Thromb Res
Año:
2018
Tipo del documento:
Article