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Prolonged tocolysis after 48 hrs with oral nifedipine does not reduce adverse perinatal outcomes

Clinical Question:
Does maintenance tocolysis with oral nifedipine, after an initial course of tocolysis and corticosteroids for 48 hours, improve perinatal outcomes in pregnant women with threatened preterm labor?

Bottom Line:
Maintenance tocolysis with oral nifedipine, after an initial course of tocolysis and corticosteroids for 48 hours, does not reduce adverse perinatal outcomes in pregnant women with threatened preterm labor. And the nonsignificant trend toward a greater occurrence of severe blood loss in women treated with nifedipine compared with placebo (13.6% vs 4.9%) is concerning. (LOE = 1b)

Reference:
Roos C, Spaanderman ME, Schuit E, et al, for the APOSTEL-II Study Group. Effect of maintenance tocolysis with nifedipine in threatened preterm labor on perinatal outcomes. A randomized controlled trial. JAMA 2013;309(1):41-47.  [PMID:23280223]

Study Design:
Randomized controlled trial (double-blinded)

Funding:
Government

Allocation:
Concealed

Setting:
Inpatient (any location)

Synopsis:
Maintenance tocolysis with beta-mimetics (eg, terbutaline), oxytocin antagonists (eg, atosiban), or magnesium sulfate, after an initial course of tocolysis and corticosteroids for 48 hours, has not been shown to improve pregnancy or perinatal outcomes. Because the effect of oral nifedipine for this purpose is currently uncertain, these investigators identified pregnant women with threatened preterm labor and a gestational age between weeks 26 and 32 who were not giving birth after 48 hours of tocolytics and corticosteroids. Preterm labor was defined using standard clinical criteria (change in cervical length, progressive dilation, ruptured membranes) and initial tocolysis was usually with nifedipine or atosiban. Both singleton and multiple pregnancies with and without ruptured membranes were included. Eligible women (n = 406) randomly received (concealed allocation assignment) nifedipine (20 mg slow release every 6 hours) or matched placebo for 12 days. The study protocol allowed the dosing interval of the study drug to be decreased to every 4 hours, if deemed clinically necessary. All personnel, including the individuals who assessed outcomes, remained masked to treatment group assignment. Follow-up occurred for all participants at 6 months after birth. The mean gestational age at randomization was 29.2 weeks; 22% of participants had multiple pregnancy and 25% had ruptured membranes. Using intention-to-treat analysis, no significant differences occurred between the 2 groups in adverse perinatal outcomes, including a composite of death, chronic lung disease, neonatal sepsis, clinically relevant brain hemorrhage, or necrotizing enterocolitis. Likewise, there were no significant differences in any of the same outcomes individually, gestational age at delivery, birth weight, neonatal intensive care unit admission or length of stay, and cesarean deliveries. Subgroup analysis also found no differences among women with singleton and multiple pregnancies, gestational age at time of treatment, and those with and without ruptured membranes. There was, however, a nonsignificant trend toward a greater occurrence of severe blood loss in women who received nifedipine compared with placebo (13.6% vs 4.9%). The trial was 80% powered to detect an 11% difference in a 2-week increase in gestational age.

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