| Part I Intrauterine double-balloon tamponade compared with gauze packingin the management of placenta previa:A randomized controlled trialBackground:Postpartum hemorrhage(PPH)during cesarean section from placenta previa is one of the leading cause of maternal morbidity and mortality[1].With China's decision to end its decades-long one-child policy,the incidence of previa appears increasing in relationship to aged mothers,previous spontaneous or elective pregnancy terminations,and importantly previous cesarean delivery.Although precisely determination of placental location prenatally provides opportunities for individualized consulting and surgical management of the disease,even without accrete,bleeding control from placental implantation site in the lower uterine segment and previa-related uterine atony still challenge.In addition to repeat doses of uterotonics and other resuscitation measures,various conservative approaches as the B-Lynch suture,local suturing of the placental bed,or other compression sutures were reported helpful.Gauze uterine packing,which was believed as a method of occlusion of the venous sinuses,is one of common methods to arrest uncontrolled PPH in low and middle source areas,as well as in our previous practice.In a recent retrospective study,90.9%of PPH women obtained hemostasis using intrauterine gauze packing without an observed increase in the risk of potential postpartum infection[4].Considering its simplicity,mini-invasive,and easy application,now that,balloon tamponade has been increased used as a first-line surgical intervention in the management of severe PPH.To avoid potential invasive intervention and hysterectomy,balloon was widely recommended in the current committee opinion[11].In order to know effectiveness and the safety of the new intrauterine double-balloon was used during cesarean section for placenta previa.,we designed a randomized controlled trial.Objective To investigate the effectiveness and the safety of the intrauterine double-balloon compared with gauze packing during cesarean section for placenta previa.Design A multicenter randomized controlled trial.Setting Nanjing Drum Tower Hospital.First Hospital of Nanjing;The First Taizhou People's Hospital.Population A total of 224 women undergoing cesarean section for placenta previa and persisting hemorrhage for intrauterine packing therapy.Method The women in the intervention arm were treated with intrauterine double-balloon tamponade.Women allocated to the control arm received gauze packing.Main outcome measures Successful bleeding arrest by avoiding second line surgeries,involving artery embolization,hysterectomy,and inverted to the other arm.Results Among women who need intrauterine packing,97.94%(95/97)and 95.88%(93/97)respectively in the double-balloon and the gauze group,successfully avoided second line interventions(P = 0.678).The double-balloon tamponade was associated with decreased PPH>1000 ml(44.33%(43/97)vs 67.01%(60/917),P = 0.001).Significantly decreased blood loss,less anemia postpartum,the lower pain score and without severe complications were found in the double-balloon group when compared with gauze packing.Conclusions Intrauterine double-balloon tamponade was and gauze packing based on the primary outcome of successful bleeding arrest rate.Double-balloon tamponade could be a good alternative to gauze packing as it was acceptable and feasible in the management of PPH from placenta previa.China Clinical Trials Registry:ChiCTR-ICR-15006467,http://www.chictr.org.cnPart ? Intrauterine double-balloon tamponade compared with gauze packingin the management of pernicious placenta previa.:A randomized controlled trialBackground:Pernicious placenta previa refers to a pregnant patient with a history of caesarean section with placenta previa and a 50%risk of placental implantation[2].Pernicious placenta previa is also defined as placenta previa attached to previous cesarean delivery scars and is often associated with placenta accrela?The placenta invades the superficial layer of the uterus and becomes placenta accrete.The placenta then invades the deep myometrial layer of the uterus making it placenta increta.If the placenta penetrates the wall of the uterus,reaches the uterus's serosa,and invades the adjacent organs,it is called placenta percreta.Pernicious placenta previa complicated with placenta accreta/increta/percreta is a serious long-term complication of cesarean sections and often leads to unmanageable,massive hemorrhaging.This can easily lead to serious complications such as disseminated intravascular coagulation and shock.For the past 10 years in China,the incidence rate of pernicious placenta previa complicated with placenta accreta/increta/percreta has gradually risen as a result of the increased use of cesarean delivery,as well as the implementation of the two-child policy[11].In order to know effectiveness and the safety of a system of multidisciplinary management combine with the new intrauterine double-balloon was used during cesarean section for pernicious placenta previa,our team designed a randomized controlled trial.Objective To investigate the effectiveness and the safety of the intrauterine double-balloon compared with gauze packing during cesarean section for pernicious placenta previa.Design A randomized controlled trial.Setting Nanjing Drum Tower Hospital.Population A total of 160 women undergoing cesarean section for pernicious placenta previa.and persisting hemorrhage for intrauterine packing therapy.Method The women in the intervention arm were treated with intrauterine double-balloon tamponade.Women allocated to the control arm received gauze packing.Main outcome measures Successful bleeding arrest by avoiding second line surgeries,involving artery embolization,hysterectomy,and inverted to the other arm.Results Among women who need intrauterine packing,100%(80/80)and 87.5%(70/80)respectively in the double-balloon and the gauze group,successfully avoided second line interventions(P = 0.001).The double-balloon tamponade was associated with decreased PPH>1000 ml(47.5%(38/80)vs 68.8%(55/80),P = 0.006).Significantly decreased blood loss,less anemia postpartum,the lower pain score and without severe complications were found in the double-balloon group when compared with gauze packing.Conclusions Intrauterine double-balloon tamponade can increased greatly the successful bleeding arrest rate compared with gauze packing.Double-balloon tamponade could be a good alternative to gauze packing as it was acceptable and feasible in the management of PPH from pernicious placenta previa... |
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