Clinical Analysis Of A New-designed Uterine Balloon In Treating The Postpartum Hemorrhage Of Uterine Atony

Objective To explore the clinical efficacy and safety of a new-designed uterine balloon in treating the postpartum hemorrhage(PPH)of uterine atony as soon as possible.Methods Prospective study the case series of 88 women with PPH attributed to uterine atony who underwent our patent new-designed intrauterine balloon tamponade when the first-line therapies such as uterotonics failed in the Affiliated Drum and Tower Hospital of Medical School of Nanjing University between January 2013 and January 2015.Analyzing the clinical data,including blood loss before and after the insertion of the intrauterine balloon,blood loss in 24 hours after delivery,blood transfusion,the levels of hemoglobin before and after delivery,the indwelling time,the inflation volume,balloon prolapse,the complications and so on.And compare to 23 women with the similar condition who used traditional homemade glove balloon to arrest bleeding of the control group from June 2010 to June 2012 when new-designed balloon did not come into use.Outcomes were statistically analyzed by t test,Mann-Whitney test,Chi-square test or Fisher’s exact test.Results The rate of PPH in the second period contributed to uterine atony was significantly lower than the first period[15.0%(1113/7441)vs 19.0%(974/5118),χ2=1 88.89,P=0.000].The success rate of intrauterine balloon in treating PPH of uterine atony by vaginal birth was no statistical difference between two groups[94.3%(83/88)vs 91.3%(21/23),P>0.05].The rate of the other invasive second-line therapies between the study group and the control group had no statistically significant difference(P>0.05).The mediam blood loss before the balloon placement,the median amount of 24 hours PPH of the two groups had statistical significant difference[1000(500-2900)vs 1300(650-2300)ml,Z=-2.98,P=0.003]and[1245(520-5905)vs 1515(900-4065)ml,Z=-2.63,P=0.009].And uterotonics-use to balloon-displacement time between two groups was statistical difference[30(10-60)vs 45(15-290)min,Z=1.6,P=0.003].The rates of blood transfusion was statistical difference beween two groups[42%(37/88)vs 91.3%(21/23),χ2=17.73,P=0.00].There was no statistical difference in hemoglobin(Hb)level before delivery,the Hb level after delivery of the study group was(88 ± 12)g/L,higher than the control group’s(81 ±17)g/L,although the difference was not significant.And the postpartum hospitalization period was shorter in the study group[3(2-15)vs 4(3-7)days,Z=-2.58,P=0.01].The reason of failure to arrest bleeding were that balloon prolapsed or could not compress effectively.No one performed hysterectomy.There was no endometritis,uterine rupture or necrosis relating to the intrauterine balloon in follow up.Conclusion Intrauterine balloon tamponade is an effective and safe measure in the management of postpartum hemorrhage because of uterine atony.When the first-line therapy fails to stop the bleeding intrauterine balloon tamponade should be applied as soon as possible,it may decrease the blood loss and blood transfusion.It is important to prevent balloon from prolapsing for hemostasis.