Key result
Oral dydrogesterone matches nifedipine for successful tocolysis while reducing NICU stay duration.
Why the study?
Does oral nifedipine improve inhibition of preterm labor compared to intravenous magnesium sulfate in women with preterm labor between 32 and 34 weeks of gestation?
RCT (n=54)
Double-blind
Simple randomization using a random number table and Excel software
No
Does oral nifedipine improve inhibition of preterm labor compared to intravenous magnesium sulfate in women with preterm labor between 32 and 34 weeks of gestation?
Absolute Event Rate: 85.2% vs 88.9%
Oral nifedipine is as effective as intravenous magnesium sulfate for inhibiting preterm labor but is associated with significantly fewer maternal adverse effects.
Nifedipine matches MgSO4 for 48-hour tocolysis with fewer maternal side effects; reinforces its preference as first-line option in preterm labor.
Objectives: The study aimed to compare the efficacy and side effects of intravenous magnesium sulfate (MgSO4) and oral nifedipine for inhibition of preterm labor. Methods: This randomized controlled trial was performed on 220 women with preterm labor between 32 and 34 weeks of gestation who were randomly assigned to receive either MgSO4 or nifedipine. The primary outcome was inhibition of preterm labor, defined as prevention of delivery for 48 hours with inhibition of uterine contraction, and the secondary outcome was maternal side effects. Results: From 220 patients, 110 received nifedipine and 110 received MgSO4. There were no differences in suppression of labor pain in 24 hours and 48 hours between the two groups. Also, there were not statistically significant differences in one-minute and five-minute Apgar scores, neonatal respiratory distress syndrome, and NICU admission between the two groups. Maternal hypotension was higher in the nifedipine group, but the difference was not significant (P = 0.08). Dyspnea (P = 0.01) and minor maternal side effects (P ≤ 0.001) were significantly higher in the MgSO4 group than the nifedipine group. Serious maternal adverse effects and severe hypotension were not seen in any of the groups. Conclusions: Nifedipine is as effective as MgSO4 in arresting labor and delaying delivery for 48 hours. However, nifedipine is associated with significantly fewer maternal adverse effects.
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Khooshideh et al. (2017) conducted an RCT in Threatened Preterm Labor (n=54). Dydrogesterone vs. Nifedipine was evaluated on Successful tocolysis. Oral dydrogesterone achieved successful tocolysis in 85.2% of pregnant women with threatened preterm labor compared to 88.9% with nifedipine, while significantly reducing the mean duration of neonatal intensive care unit stay.
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