The purpose of this study to compare breast milk pharmacokinetics between miso prostol 200 μg and methylergometrine 250 μg after single oral dosing in women who require postpartum uterotonic therapy. Open prospectiv...The purpose of this study to compare breast milk pharmacokinetics between miso prostol 200 μg and methylergometrine 250 μg after single oral dosing in women who require postpartum uterotonic therapy. Open prospective randomized phase I s tudy measuring misoprostol and methylergometrine on postpartum days 3 to 6 in mi lk 0.5, 1, 2, 3, 4, and 5 hours postdose, and in maternal serum at 0.5 and 1 hou rs (misoprostol) and 1 and 2 hours (methylergometrine) in 10 lactating women per group. Milk misoprostol levels rose and declined rapidly, which gave a milk eli mination half-life of less than one half that of methylergometrine (mean ±SE,1 .1 ±0.3 hours [median, 0.6 hours] vs 2.33 ±.0.3 hours [median, 1.9 hours]; P = . 003)-. Milk/plasma ratios for misoprostol were one third of those for methyle rgometrine at 1 hour (P <. 0001) and 2 hours (P <. 0015). Misoprostol warrants f urther investigation as an alternative to postpartum methylergometrine because i t enters and leaves breast milk at twice the rate, with one third of the milk/pl asma ratio, which significantly lowers infant exposure and facilitates a timed d osing regimen.展开更多
Objective: To compare the efficacy and side effects of sublingual misoprostol and intravenous methylergometrine for active management of third stage of labor. Method: One hundred twenty low risk pregnant women at term...Objective: To compare the efficacy and side effects of sublingual misoprostol and intravenous methylergometrine for active management of third stage of labor. Method: One hundred twenty low risk pregnant women at term with spontaneous onset of labor were included in the study. The women were randomized to receive either two tablets of misoprostol (200 μ g/tablet) sublingually or 1 ml of methylergometrine (200 μ g) intravenous injection, after the delivery of the anterior shoulder of the baby. The main outcome measures were: need for additional oxytocic drugs, blood loss ≥ 500 ml, change in hemoglobin levels and side effects. Results: Postpartum hemorrhage as defined by hemorrhage ≥ 500 ml occurred in 3.1% of the women in the sublingual misoprostol group but none of the women in the methylergometrine group (P > 0.05). There was a need for additional oxytocic drugs in 5.0% and 8.3% after methylergometrine and misoprostol, respectively (P > 0.05). The change in hemoglobin levels at 24 h postpartum were 0.8 and 0.7 mg% in methylergometrine and misoprostol group, respectively(P > 0.05). In the misoprostol group, 6.6% women developed fever ≥ 38° C and 21.6% had shivering while in methylergometrine group none experienced these side effects. However, the incidence of other side effects like nausea, vomiting, headache and giddiness were similar in both groups. Conclusion: Sublingual misoprostol appears to be as effective as intravenous methylergometrine in the prevention of postpartum hemorrhage. However, larger randomized studies are needed to advocate its routine use.展开更多
文摘The purpose of this study to compare breast milk pharmacokinetics between miso prostol 200 μg and methylergometrine 250 μg after single oral dosing in women who require postpartum uterotonic therapy. Open prospective randomized phase I s tudy measuring misoprostol and methylergometrine on postpartum days 3 to 6 in mi lk 0.5, 1, 2, 3, 4, and 5 hours postdose, and in maternal serum at 0.5 and 1 hou rs (misoprostol) and 1 and 2 hours (methylergometrine) in 10 lactating women per group. Milk misoprostol levels rose and declined rapidly, which gave a milk eli mination half-life of less than one half that of methylergometrine (mean ±SE,1 .1 ±0.3 hours [median, 0.6 hours] vs 2.33 ±.0.3 hours [median, 1.9 hours]; P = . 003)-. Milk/plasma ratios for misoprostol were one third of those for methyle rgometrine at 1 hour (P <. 0001) and 2 hours (P <. 0015). Misoprostol warrants f urther investigation as an alternative to postpartum methylergometrine because i t enters and leaves breast milk at twice the rate, with one third of the milk/pl asma ratio, which significantly lowers infant exposure and facilitates a timed d osing regimen.
文摘Objective: To compare the efficacy and side effects of sublingual misoprostol and intravenous methylergometrine for active management of third stage of labor. Method: One hundred twenty low risk pregnant women at term with spontaneous onset of labor were included in the study. The women were randomized to receive either two tablets of misoprostol (200 μ g/tablet) sublingually or 1 ml of methylergometrine (200 μ g) intravenous injection, after the delivery of the anterior shoulder of the baby. The main outcome measures were: need for additional oxytocic drugs, blood loss ≥ 500 ml, change in hemoglobin levels and side effects. Results: Postpartum hemorrhage as defined by hemorrhage ≥ 500 ml occurred in 3.1% of the women in the sublingual misoprostol group but none of the women in the methylergometrine group (P > 0.05). There was a need for additional oxytocic drugs in 5.0% and 8.3% after methylergometrine and misoprostol, respectively (P > 0.05). The change in hemoglobin levels at 24 h postpartum were 0.8 and 0.7 mg% in methylergometrine and misoprostol group, respectively(P > 0.05). In the misoprostol group, 6.6% women developed fever ≥ 38° C and 21.6% had shivering while in methylergometrine group none experienced these side effects. However, the incidence of other side effects like nausea, vomiting, headache and giddiness were similar in both groups. Conclusion: Sublingual misoprostol appears to be as effective as intravenous methylergometrine in the prevention of postpartum hemorrhage. However, larger randomized studies are needed to advocate its routine use.