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Double-blind evaluation of ritodrine sustained release for oral maintenance of tocolysis after active preterm labour
C A Holleboom1, J M Merkus, L W van Elferen
1Department of Obstetrics and Gynaecology, bronovo Hospital, The Hague, The Netherlands.
Objective:
To evaluate the effect of ritodrine sustained release capsules for maintaining uterine quiescence after successful treatment of active preterm labour.
Design:
Multicentre placebo-controlled trial.
Setting:
Five teaching hospitals in the Netherlands.
Participants:
Women (n = 95) at less than 35 weeks of gestation in whom active preterm labour had been stopped with intravenous ritodrine.
Interventions:
Women received either two 40 mg ritodrine sustained release capsules (n = 50) or identical placebo capsules (n = 45) three times a day for seven days.
Results:
The proportion of women who received another course of active treatment was significantly smaller with the sustained release than with placebo (1 of 50 versus 11 of 45: P = 0.003) as was the number delivering because of preterm labour during treatment (0 of 50 versus 4 of 45: P = 0.04). There were no other significant differences between the two groups.
Conclusions:
Maintenance treatment with ritodrine sustained release capsules after arrest of preterm labour reduces the risk of recurrences of preterm labour that necessitate treatment or precipitate delivery.