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Download guidance PDF. All forms of antihypertensive therapy were associated with a higher risk for SGA, preterm birth and admission to the NICU, and multiple therapy had the strongest association with these events.
Several study limitations should caution the reader from drawing definitive conclusions about the impact of antihypertensive therapy on perinatal outcome. First, we did not obtain information on drug dose, duration of use or route of administration.
Thus, this study provides no information about the existence of a dose-response relationship between drug use and adverse perinatal events. Because this was not a randomized clinical trial, bias due to confounding by indication was likely present, in that women with milder forms of hypertension may have received lower doses of oral therapy e.
However, we do know that because the most commonly used agents in this study — atenolol, nifedipine and methyldopa — were not available intravenously, their use probably extended beyond the acute management of severe maternal hypertension with impending delivery. Similarly, there may have been a lower threshold for induction of labor or Cesarean delivery among women who were referred to our center for the management of more complex or severe maternal hypertension or fetal disease.
Thus, because these data may be biased, and their internal and external validity questioned, they may not be applicable to some women with stable, mild and asymptomatic hypertension. In the second review, comparing antihypertensive drugs with placebo or no treatment, active therapy reduced the risk of severe hypertension 24 trials; RR 0. The advantage of a large, prospective study like MOS HIP 2 is its ability to examine several important "hard" perinatal outcomes, and to generate estimates of effect size with statistical certainty.
MOS HIP 2 provided information on perinatal outcomes within the realm of clinical practice, and included a broad array of women with different mechanisms and degrees of hypertension. By adjusting for multiple potential confounders, such as the gestational age at which the BP rose, we may have reduced the likelihood that antihypertensive drug use was merely a marker of both the acuity and degree of hypertension and, accordingly, the associated risk of preterm delivery and neonatal prematurity.
Similarly, by limiting our sub-group analysis to women with chronic hypertension, we increased the likelihood that maternal exposure to antihypertensive therapy would be of longer duration. Even randomized clinical trials [ 2 , 3 , 5 ] of active therapy are biased by the presence of co-intervention, cross-over, contamination and drop-outs. For example, in a well-publicized clinical trial by Butters et al.
Infants of mothers assigned atenolol weighed an average of g less than those in the placebo group, but four women in the placebo group withdrew from the study. A second trial compared atenolol with placebo for the treatment of mild gestational hypertension during the third trimester, with no difference in birthweight between groups; however, data were reported on only 85 of women A recent clinical trial randomized 56 asymptomatic women with an increased cardiac output before 24 weeks gestation to either atenolol or placebo [ 20 ].
For the primary outcome of preeclampsia, the relative risk was 0. Thus, although it is possible that atenolol may cause some degree of growth restriction, this has not been demonstrated when the drug is compared to another form of active treatment [ 3 ], or in the presence of more severe hypertension, when maternal benefit may be greater. It may not be surprising that the risk of preterm delivery in our study was significantly associated with the use of antihypertensive therapy, since the initiation of therapy might simply reflect the onset of either new or worsening hypertension and the need for delivery.
Combined antihypertensive therapy was a strong marker for preterm birth and a moderate indicator of SGA. Further research might investigate whether there are differences in placental blood flow and fetal growth according to treatment regimen monotherapy vs. Thus, these findings, which are hypothesis generating, should be tested by a study capable of demonstrating causation.
A large international randomized active-control clinical trial is urgently needed to help resolve the controversy surrounding the safety and efficacy for mother and child of treating hypertension during pregnancy. The reasons for such a large double-masked clinical trial are many [ 23 ], including the fact that the condition is common; the choices for therapy are few, unlikely to change for several years and inexpensive; and the time to outcome is less than 40 weeks.
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