Abstract Background: Recurrent miscarriage affects 1–2% of women. Thrombophilia included
antiphospholipid syndrome has been identified in about 50% of women with recurrent miscarriage.
Aspirin and heparin therapy is frequently prescribed for APS, yet there is no robust evidence for the
most efficacious regime.
Objective: To determine maternal and foetal outcomes in women with APS managed with aspirin
or enoxaparin plus aspirin during pregnancy.
Design: Prospective non randomized study.
Setting: High-risk pregnancy unit-Benha University Hospital.
Methods: Seventy selected patients during pregnancy with clinical and/or serological findings of
antiphospholipid syndrome were divided into two Groups: Group A (n= 47) had received aspirin
(81 mg once daily orally) plus LMWH enoxaparin (40 mg subcutaneously/day) while Group B
(n=23) had received low-dose aspirin (81 mg day orally).
Main outcome measures: Maternal outcomes included thromboembolic, haemorrhagic complications
and pregnancy-induced hypertension. Prematurity, intrauterine growth restriction and neonatal
death were considered as foetal complications.
Results: There were significant differences between Groups A and B in the rate of miscarriages (4
in Group A (9%) versus 8 in Group B (35%); p= 0.02), number of live births (43/47(91%) versus
15/23(65%); p=0.02), mean gestational age (37.86± 1.8 versus 36.13 ± 2.39 weeks; p=0.005),
neonatal birth weight (3252 ± 459 versus 2907± 618 g; p= 0.03) and rate of pre-eclampsia
(3/43 (7%) versus 6/15 (40%); p= 0.009). Although not statistically significant, women in Group A tended to have lower rates of preterm births (6/43 (14%) versus 3/15 (20%); p= 0.89) and IUGR
(5/43 (12%) versus 5/15 (33%); p= 0.13) than in Group B.
Conclusions: Use of low dose aspirin and enoxaparin 40 mg subcutaneously daily in patients
with RPL due to antiphospholipid syndrome resulted in higher live birth rates compared to low
dose aspirin alone. Solid conclusions from this study are limited due to the small number of
patients, non-randomization of groups and discrepancy in number between groups because the
choice of the interventional drug was left to patient’s preference after counselling. A larger RCT
is needed. |
