Objective To determine the need for, and efficacy of, treatment with labetalol in women with mild‐to‐moderate pregnancy induced hypertension (PIH). Design Prospective double‐blind randomised placebo controlled study. Setting Maternity units of five hospitals in the Trent Region. Subjects 144 women (86 primigravid) who developed PIH after 20 weeks gestation. Interventions Treatment with oral labetalol up to 600 mg daily or placebo with subsequent care of treatment failures in accordance with the attending obstetrician's practice. Main outcome measures Number of days spent as an antenatal inpatient; the development of proteinuria; the perceived need for induction of labour or elective caesarean section; and gestation age at delivery. Results Labetalol significantly lowered the blood pressure and reduced the incidence of proteinuria. However, neither the number of days spent as an antenatal inpatient, nor the perceived need for induction of delivery or elective caesarean section, nor the gestation age at delivery differed significantly between the two treatment groups. Post‐randomisation consideration of early (≤32 weeks) and late (>32 weeks) onset groups showed the placebo treated early‐onset group (n= 15) to have more patients with severe hypertension (>150/110 mmHg) and a greater requirement for additional antihypertensive therapy prior to labour than the group treated with labetalol (n= 16). Conclusion Anti‐hypertensive intervention therapy in pregnancy induced hypertension has been examined using a placebo controlled randomised double‐blind trial of labetalol in pregnancy. The maximum blood pressure prior to labour and the incidence of proteinuria was reduced in women on active therapy. However, the length of gestation was not significantly prolonged and indices of clinical outcome were not significantly altered. The appropriateness of pharmacological therapy for late‐onset PIH may be questioned.

Summary. The effects of labetalol were compared with those of placebo in a multicentre randomized double‐blind and prospective study of 152 patients with mild to moderate, non‐proteinuric pregnancy‐induced hypertension. Labetalol in a dose of 100 mg three times daily, increasing to 200 mg three times daily where required, significantly reduced maternal mean arterial pressure. There was some reduction in preterm delivery, neonatal respiratory distress syndrome and jaundice in the labetalol‐treated group. Intrauterine growth retardation and neonatal hypoglycaemia occurred with the same frequency in both groups. There were no perinatal deaths. Labetalol appears to be an effective agent in the management of mild to moderate pregnancy‐induced hypertension. The data from this study suggest possible advantages and no apparent disadvantages for the fetus during its use.

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