Authors |
A.M. Badawy,
M. Khiary, L. S. Sherif,
M. Hassan, A. Ragab, I. Abdelall |
Journal |
Journal of de Obstetrics and Gynecology |
Year
of publication |
2008 |
Country |
Egypt |
Period |
From February, 2003 to January, 2006 |
Study
Designer |
Prospective randomized study |
Randomization |
Women were randomly allocated to either
group A (thromboprophylaxis group, n=170) or group B (control group n=170)
using pre-filled sealed envelopes designed by the investigators for each
patient. |
Inclusion
criteria |
Pregnant
women before 8 weeks of gestation with a history of three or more consecutive
first trimester abortion (first 12 weeks of gestation) with no identifiable
etiology after full investigations. Habitual abortion was defined as a
history of three or more consecutive abortions in the first trimester. |
Exclusion
criteria |
Women with any identifiable etiology
for spontaneous abortions, such as hereditary thrombophilia. |
Participant demographic data |
There are no
significant differences between the two groups. The age of the patients in
the study ranged from 18 to 36 years. A total of 52 patients (30.5%) in group
A and 45 patients (26.4%) in group B had deliveries before completing the
full term. There was a high incidence of pre-pregnancy complications such as
fetal loss (12-21 weeks), preeclampsia, placental detachment, small for
gestational age and fetal birth, but without significant differences between
the two groups. |
Types
of interventions |
Group A: Low
molecular weight heparin prescribed (enoxaparin sodium 0.2 ml, 20 mg once
daily subcutaneously, Clexane®, Aventis Pharma, Egypt)
from the time of ultrasonographic confirmation of fetal viability up to
34-week pregnancy and folic acid tablets 0.5 mg daily up to 13 weeks
gestation. Platelet counts and activated partial thromboplastin time (usually
25-35 weeks) were performed 10 to 20 days from the start of treatment and
every month thereafter until 34 weeks of gestation.
Group B:
Folic acid prescribed 0.5 mg tablets daily up to 13 weeks of gestation.
Prenatal visits were made for all patients every 2 weeks until the first 20
weeks and then every 4 weeks until 36 weeks and then every week until
delivery. During prenatal visits, obstetric ultrasound and laboratory
investigation were performed for all patients. |
Results
measures |
End of pregnancy and its results |
Results |
LMWH appears
to be a safe and effective drug in significantly reducing the incidence of
recurrent miscarriages of unknown etiology when administered in the first
trimester and continued throughout pregnancy. |