PDF(Pubmed)
Abstract：
OBJECTIVE: The purpose of this study is to evaluate the oral probiotic effect on pregnancy outcomes in pregnant women undergoing cerclage compared to placebo.
METHODS: This study was a double-blind randomized clinical trial undertaken in Yasuj, Iran. 114 eligible participants who have undergone cerclage were randomly divided to either receive probiotic adjuvant or 17α-OHP (250 mg, IM) with placebo from the 16th -37th week of pregnancy by \"block\" randomization method. Our primary outcomes were preterm labor (PTB) (late and early) and secondary outcomes were other obstetrical and neonatal outcomes included preterm pre-labor rupture of membranes (PPROM), pre-labor rupture of membranes (PROM), mode of delivery, and neonatal outcomes including anthropometric characterize and Apgar score (one and fifth-minute).
RESULTS: Results show that there are no statistically significant differences between the two groups in terms of PTB in < 34th (15.51% vs. 17.86%; P = 0.73) and 34-37th weeks of pregnancy (8.7% vs. 16.1%; P = 0.22), and mode of delivery (P = 0.09). PPROM (8.7% vs. 28.5%; P = 0.006) PROM (10.3% vs. 25%; P = 0.04) was significantly lower in patients receiving probiotic adjuvant compared to the control group. After delivery, the findings of the present study showed that there were no significant differences in newborn\'s weight (3082.46 ± 521.8vs. 2983.89 ± 623.89), head circumstance (36.86 ± 1.53vs. 36.574 ± 1.52), height (45.4 ± 5.34 vs. 47.33 ± 4.92) and Apgar score in one (0.89 ± 0.03 vs. 0.88 ± 0.05) and five minutes (0.99 ± 0.03vs. 0.99 ± 0.03) after birth.
CONCLUSIONS: Our result has shown that the consumption of Lactofem probiotic from the 16th week until 37th of pregnancy can lead to a reduction of complications such as PPROM and PROM.
METHODS: This study was a double-blind randomized clinical trial undertaken in Yasuj, Iran. 114 eligible participants who have undergone cerclage were randomly divided to either receive probiotic adjuvant or 17α-OHP (250 mg, IM) with placebo from the 16th -37th week of pregnancy by \"block\" randomization method. Our primary outcomes were preterm labor (PTB) (late and early) and secondary outcomes were other obstetrical and neonatal outcomes included preterm pre-labor rupture of membranes (PPROM), pre-labor rupture of membranes (PROM), mode of delivery, and neonatal outcomes including anthropometric characterize and Apgar score (one and fifth-minute).
RESULTS: Results show that there are no statistically significant differences between the two groups in terms of PTB in < 34th (15.51% vs. 17.86%; P = 0.73) and 34-37th weeks of pregnancy (8.7% vs. 16.1%; P = 0.22), and mode of delivery (P = 0.09). PPROM (8.7% vs. 28.5%; P = 0.006) PROM (10.3% vs. 25%; P = 0.04) was significantly lower in patients receiving probiotic adjuvant compared to the control group. After delivery, the findings of the present study showed that there were no significant differences in newborn\'s weight (3082.46 ± 521.8vs. 2983.89 ± 623.89), head circumstance (36.86 ± 1.53vs. 36.574 ± 1.52), height (45.4 ± 5.34 vs. 47.33 ± 4.92) and Apgar score in one (0.89 ± 0.03 vs. 0.88 ± 0.05) and five minutes (0.99 ± 0.03vs. 0.99 ± 0.03) after birth.
CONCLUSIONS: Our result has shown that the consumption of Lactofem probiotic from the 16th week until 37th of pregnancy can lead to a reduction of complications such as PPROM and PROM.
摘要：
目的：本研究的目的是评估与安慰剂相比，口服益生菌对环扎术孕妇妊娠结局的影响。
方法：本研究是一项在Yasuj进行的双盲随机临床试验，伊朗。114名接受环扎的合格参与者被随机分为接受益生菌佐剂或17α-OHP(250毫克，IM）从怀孕第16-37周开始服用安慰剂，采用“阻滞”随机方法。我们的主要结局是早产（PTB）（晚期和早期），次要结局是其他产科和新生儿结局，包括早产胎膜破裂（PPROM）。产前胎膜破裂（PROM），交货方式,和新生儿结局，包括人体测量特征和Apgar评分（1分钟和5分钟）。
结果：结果表明，在<34岁时，两组之间的PTB没有统计学上的显着差异（15.51％vs.17.86%；P=0.73）和怀孕34-37周（8.7%vs.16.1%；P=0.22），和交货方式(P=0.09)。PPROM（8.7%与28.5%；P=0.006）PROM（10.3%vs.25％；P=0.04）与对照组相比，接受益生菌佐剂的患者显着降低。交货后,本研究的结果表明，新生儿体重无显著差异(3082.46±521.8vs.2983.89±623.89),头部情况(36.86±1.53vs.36.574±1.52),高度(45.4±5.34vs.47.33±4.92）和Apgar评分在一个（0.89±0.03vs.0.88±0.05）和五分钟（0.99±0.03vs.出生后0.99±0.03）。
结论：我们的研究结果表明，从第16周到第37周服用Lactofem益生菌可以减少PPROM和PROM等并发症。
方法：本研究是一项在Yasuj进行的双盲随机临床试验，伊朗。114名接受环扎的合格参与者被随机分为接受益生菌佐剂或17α-OHP(250毫克，IM）从怀孕第16-37周开始服用安慰剂，采用“阻滞”随机方法。我们的主要结局是早产（PTB）（晚期和早期），次要结局是其他产科和新生儿结局，包括早产胎膜破裂（PPROM）。产前胎膜破裂（PROM），交货方式,和新生儿结局，包括人体测量特征和Apgar评分（1分钟和5分钟）。
结果：结果表明，在<34岁时，两组之间的PTB没有统计学上的显着差异（15.51％vs.17.86%；P=0.73）和怀孕34-37周（8.7%vs.16.1%；P=0.22），和交货方式(P=0.09)。PPROM（8.7%与28.5%；P=0.006）PROM（10.3%vs.25％；P=0.04）与对照组相比，接受益生菌佐剂的患者显着降低。交货后,本研究的结果表明，新生儿体重无显著差异(3082.46±521.8vs.2983.89±623.89),头部情况(36.86±1.53vs.36.574±1.52),高度(45.4±5.34vs.47.33±4.92）和Apgar评分在一个（0.89±0.03vs.0.88±0.05）和五分钟（0.99±0.03vs.出生后0.99±0.03）。
结论：我们的研究结果表明，从第16周到第37周服用Lactofem益生菌可以减少PPROM和PROM等并发症。
