Printer friendly

This Cochrane review includes randomized or quasi-randomized controlled trials on pregnant women with at least one fetal loss, evidence of Antiphospholipid (APL) antibodies and receiving any type of therapy; women with false-positive VDRL tests were also included in the trials. A total of 13 trials involving 849 participants satisfied the review’s broad inclusion criteria.

The only significant benefit of therapy observed was that the combination of unfractionated heparin and aspirin reduced pregnancy loss by 54% (Relative Risk [RR] 0.46, 95% Confidence Interval [CI]: 0.29 to 0.71) compared with aspirin alone. When low-molecular-weight (LMW) heparin and unfractionated heparin studies were pooled, there was a 35% reduction in pregnancy loss or preterm delivery (RR 0.65, 95% CI: 0.49 to 0.86). The different dosages of heparin used in the studies reviewed did not alter the outcomes. Therefore, the optimal dose of heparin—one that would yield maximum benefit with minimum harm—is still unknown. None of the other interventions tested had any significant beneficial effects on pregnancy outcome compared with placebo although, a small benefit from aspirin cannot be excluded. In contrast, intravenous immunoglobulin (IVIG) and prednisone did not show benefits, but had adverse effects. Adverse outcomes like pregnancy loss and preterm delivery were more in women treated with prednisone. This group of mothers also had significantly more gestational diabetes, and infants born to them were of low birth weight and were more frequently admitted to intensive care units. Pre-eclampsia and hypertension also appeared to be more common in these women. IVIG was also associated with increased risk of pregnancy loss or preterm delivery. Therefore, these two agents may have no role in the treatment of recurrent pregnancy loss associated with APL. However, when other indications are present, for example, active systemic lupus erythematosus, the potential benefits should be weighed against the potential harms. The review did not include any trials of plasmapheresis. The trials lacked sufficient data to draw any conclusions regarding hypertension, pre-eclampsia or the long term effects (like osteoporosis) of the therapies studied.

In addition, the numbers studied were small, limiting the precision of all estimates. The quality of trials was also variable. Some studies did not conceal allocation and in certain others it was not clear whether the analyses were performed by ‘intent to treat’ and the number of women with a history of miscarriages presenting themselves at the health care facility during the recruitment phase was not available. Although the review shows benefit only with the combination of unfractionated heparin and aspirin, in treating women with APL and recurrent pregnancy loss, this is unlikely to be the final word since the evidence base at the present time is small.

The full RHL commentary also includes sections on: