Dataset Information

Intrauterine double-balloon tamponade vs gauze packing in the management of placenta previa: A multicentre randomized controlled trial.

ABSTRACT:

Background

To evaluate the effectiveness and safety of a newly designed intrauterine double-balloon catheter to arrest postpartum hemorrhage (PPH) following cesarean delivery (CD) for placenta previa.

Methods

We conducted an open-label, multicenter randomized controlled trial in two referral centers and one general hospital. Women with continuous bleeding after placental delivery following CD for placenta previa, who failed to respond to uterotonics, suturing and uterine devascularization, and in the absence of suspected deeply invasive accreta were eligible subjects. Eligible subjects were randomized to receive intrauterine double-balloon catheter (n?=?102) or gauze packing (n?=?102). The main outcome was the rate of successful hemostasis without the need for additional surgical interventions. The secondary outcomes included the volume of blood loss during and after CD, the rate of PPH, incidence and amount of blood transfusion, hysterectomy, surgical complications, intensive care unit admission, need for re-laparotomy, length of hospital stay, and readmission.

Results

The 224 participants were recruited before delivery, with 20 excluded (14 cases bleeding stopped after uterotonics and/or local myometrium sutures and 6 patients with placental increta). Finally, 102 women were assigned in catheter group and 102 others in gauze group. There was no difference in the rate of successful hemostasis in the catheter and gauze groups (93.1% vs 91.2%, P?=?.80). Compared with those in the gauze group, women in the catheter group showed significantly less blood loss within 24?hours postpartum (895 [612.3-1297.8] vs 1156 [882.5-1453.3] ml, P?ConclusionUterine tamponade using a double-balloon catheter was as effective as gauze packing in hemostasis, and appeared to be superior in reducing postpartum blood loss and pain following CD for placenta previa. Using double-balloon catheter in managing PPH in this situation may be a preferable alternative to minimize maternal morbidity.

SUBMITTER: Wei J

PROVIDER: S-EPMC7035072 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Publications

Intrauterine double-balloon tamponade vs gauze packing in the management of placenta previa: A multicentre randomized controlled trial.

Wei Jing J Dai Yimin Y Wang Zhiqun Z Gu Ning N Ju Hongfang H Xu Youdi Y Xu Biyun B Hu Yali Y

Medicine 20200201 7

<h4>Background</h4>To evaluate the effectiveness and safety of a newly designed intrauterine double-balloon catheter to arrest postpartum hemorrhage (PPH) following cesarean delivery (CD) for placenta previa.<h4>Methods</h4>We conducted an open-label, multicenter randomized controlled trial in two referral centers and one general hospital. Women with continuous bleeding after placental delivery following CD for placenta previa, who failed to respond to uterotonics, suturing and uterine devascula ...[more]

PMID: 32049861

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Project description:Placenta previa and placenta accreta carry significant maternal and fetal morbidity and mortality. Several techniques have been described in the literature for controlling massive bleeding associated with placenta previa cesarean sections. The objective of this study was to evaluate the efficacy and safety of the use of the cervix as a natural tamponade in controlling postpartum hemorrhage caused by placenta previa and placenta previa accreta.This prospective study was conducted on 40 pregnant women admitted to our hospital between June 2012 and November 2014. All participating women had one or more previous cesarean deliveries and were diagnosed with placenta previa and/or placenta previa accreta. Significant bleeding from the placental bed during cesarean section was managed by inverting the cervix into the uterine cavity and suturing the anterior and/or the posterior cervical lips into the anterior and/or posterior walls of the lower uterine segment.The technique of cervical inversion described above was successful in stopping the bleeding in 38 out of 40 patients; yielding a success rate of 95%. We resorted to hysterectomy in only two cases (5%). The mean intra-operative blood loss was 1572.5 mL, and the mean number of blood units transfused was 3.1. The mean time needed to perform the technique was 5.4?±?0.6 min. The complications encountered were as follows: bladder injury in the two patients who underwent hysterectomy and wound infection in one patient. Postoperative fever that responded to antibiotics occurred in 1 patient. The mean duration of the postoperative hospital stay was 3.5 daysThis technique of using the cervix as a natural tamponade appears to be safe, simple, time-saving and potentially effective method for controlling the severe postpartum hemorrhage (PPH) caused by placenta previa/placenta previa accreta. This technique deserves to be one of the tools in the hands of obstetricians who face the life-threatening hemorrhage of placenta accreta.ClinicalTrials.gov NCT02590484 . Registered 28 October 2015.

Project description:BackgroundThe correlation between gestational hypertension-preeclampsia (GH-PE) and placenta previa (PP) is controversial. Specifically, it is unknown whether placenta previa has any effect on the various types of preeclampsia (PE), and the role PP with concurrent placenta accreta (PA) play in the occurrence of GH-PE are not well understood.ObjectiveThe aim of this study was to identify the effects of PP on GH, mild and severe preeclampsia (MPE and SPE), and early- and late-onset preeclampsia (EPE and LPE). Another aim of the study was to determine if concurrent PA impacts the relationship between PP and GH-PE.MethodsA retrospective single-center study of 1,058 patients having singleton pregnancies with PP was performed, and 2,116 pregnant women were randomly included as controls. These cases were collected from a tertiary hospital and met the inclusion criteria for the study. Clinical information, including PP and the gestational age at the onset of GH-PE were collected. Binary and multiple logistic regression analyses were conducted after the confounding variables were controlled to assess the effects of PP on different types of GH-PE.ResultsThere were 155 patients with GH-PE in the two groups. The incidences of GH-PE in the PP group and the control group were 2.5% (26/1058) and 6.1% (129/2116), respectively (P = 0.000). Binary and multiple regression analyses were conducted after controlling for confounding variables. Compared to the control group, in the PP group, the risk of GH-PE was reduced significantly by 78% (AOR: 0.216; 95% CI: 0.135-0.345); the risks of GH and PE were reduced by 55% (AOR: 0.451; 95% CI: 0.233-0.873) and 86% (AOR: 0.141; 95% CI: 0.073-0.271), respectively; the risks of MPE and SPE were reduced by 73% (AOR: 0.269; 95% CI: 0.087-0828) and 88% (AOR: 0.123; 95% CI: 0.055-0.279), respectively; and the risks of EPE and LPE were reduced by 95% (AOR: 0.047; 95% CI: 0.012-0.190) and 67% (AOR: 0.330; 95% CI: 0.153-0.715), respectively. The incidence of concurrent PA in women with PP was 5.86%; PP with PA did not significantly further reduce the incidence of GH-PE compared with PP without PA (1.64% vs. 2.51%, P>0.05). Binary logistic regression analyses were conducted after controlling for confounding variables, compared with the non-PP + GH-PE group, and the AOR of FGR in the non-PP + non-GH-PE group was 0.206 (0.124-0.342). Compared with the PP + GH-PE group, the AOR of FGR in the PP + non-GH-PE group was 0.430 (0.123-1.500).ConclusionPP is not only associated with a significant reduction in the incidence of GH-PE, but also is associated with a reduction in incidence of various types of PE. Concurrent PA and PP do not show association with a reduction in incidence of GH-PE.

Project description:OBJECTIVE:To estimate the prevalence and incidence of placenta previa complicated by placenta accreta spectrum (PAS) and to examine the different criteria being used for the diagnosis. DESIGN:Systematic review and meta-analysis. DATA SOURCES:PubMed, Google Scholar, ClinicalTrials.gov and MEDLINE were searched between August 1982 and September 2018. ELIGIBILITY CRITERIA:Studies reporting on placenta previa complicated by PAS diagnosed in a defined obstetric population. DATA EXTRACTION AND SYNTHESIS:Two independent reviewers performed the data extraction using a predefined protocol and assessed the risk of bias using the Newcastle-Ottawa scale for observational studies, with difference agreed by consensus. The primary outcomes were overall prevalence of placenta previa, incidence of PAS according to the type of placenta previa and the reported clinical outcomes, including the number of peripartum hysterectomies and direct maternal mortality. The secondary outcomes included the criteria used for the prenatal ultrasound diagnosis of placenta previa and the criteria used to diagnose and grade PAS at birth. RESULTS:A total of 258 articles were reviewed and 13 retrospective and 7 prospective studies were included in the analysis, which reported on 587 women with placenta previa and PAS. The meta-analysis indicated a significant (p<0.001) heterogeneity between study estimates for the prevalence of placenta previa, the prevalence of placenta previa with PAS and the incidence of PAS in the placenta previa cohort. The median prevalence of placenta previa was 0.56% (IQR 0.39-1.24) whereas the median prevalence of placenta previa with PAS was 0.07% (IQR 0.05-0.16). The incidence of PAS in women with a placenta previa was 11.10% (IQR 7.65-17.35). CONCLUSIONS:The high heterogeneity in qualitative and diagnostic data between studies emphasises the need to implement standardised protocols for the diagnoses of both placenta previa and PAS, including the type of placenta previa and grade of villous invasiveness. PROSPERO REGISTRATION NUMBER:CRD42017068589.

Project description:BackgroundA diagnostic sign on magnetic resonance imaging, suggestive of posterior extrauterine adhesion (PEUA), was identified in patients with placenta previa. However, the clinical features or surgical outcomes of patients with placenta previa and PEUA are unclear. Our study aimed to investigate the clinical characteristics of placenta previa with PEUA and determine whether an altered management strategy improved surgical outcomes.MethodsThis single institution retrospective study examined patients with placenta previa who underwent cesarean delivery between 2014 and 2019. In June 2017, we recognized that PEUA was associated with increased intraoperative bleeding; thus, we altered the management of patients with placenta previa and PEUA. To assess the relationship between changes in practice and surgical outcomes, a quasi-experimental method was used to examine the difference-in-difference before (pre group) and after (post group) the changes. Surgical management was modified as follows: (i) minimization of uterine exteriorization and adhesion detachment during cesarean delivery and (ii) use of Nelaton catheters for guiding cervical passage during Bakri balloon insertion. To account for patient characteristics, propensity score matching and multivariate regression analyses were performed.ResultsThe study cohort (n = 141) comprised of 24 patients with placenta previa and PEUA (PEUA group) and 117 non-PEUA patients (control group). The PEUA patients were further categorized into the pre (n = 12) and post groups (n = 12) based on the changes in surgical management. Total placenta previa and posterior placentas were more likely in the PEUA group than in the control group (66.7% versus 42.7% [P = 0.04] and 95.8% versus 63.2% [P < 0.01], respectively). After propensity score matching (n = 72), intraoperative blood loss was significantly higher in the PEUA group (n = 24) than in the control group (n = 48) (1515 mL versus 870 mL, P < 0.01). Multivariate regression analysis revealed that PEUA was a significant risk factor for intraoperative bleeding before changes were implemented in practice (t = 2.46, P = 0.02). Intraoperative blood loss in the post group was successfully reduced, as opposed to in the pre group (1180 mL versus 1827 mL, P = 0.04).ConclusionsPEUA was associated with total placenta previa, posterior placenta, and increased intraoperative bleeding in patients with placenta previa. Our altered management could reduce the intraoperative blood loss.

Project description:INTRODUCTION:We aimed to evaluate the site of placentation on the pregnancy outcomes of patients with placenta previa. METHODS:This retrospective study included 678 cases of placenta previa. Basic information and pregnancy outcome data were collected. Differences between the different placenta previa positions and pregnancy outcomes were compared using the chi-square and independent t tests. Logistic and multiple regression analyses were used to calculate the odds ratios (ORs) to determine the risk factors for PAS disorders and postpartum hemorrhage and evaluate the effect of placental attachment site on pregnancy outcomes. RESULTS:There was no significant difference between the PAS disorders rate and the incidence of complete placenta previa depending on the type of placentation; however, placental attachment site influenced the pregnancy outcome. Placental attachment to the anterior wall was associated with shorter gestational age, low birth weight, lower Apgar score, higher prenatal bleeding rate, increased postpartum hemorrhage, longer duration of hospitalization, and higher blood transfusion and hysterectomy rates compared to cases with lateral/posterior wall placenta. Placental attachment at the incision site of a previous cesarean section significantly increased the incidence of complete placenta previa and PAS disorders compared with placental attachment at a site without incision, but did not significantly influence pregnancy outcomes. Placental attachment to the anterior wall was an independent risk factor for postpartum hemorrhage in patients with placenta previa. Placental attachment to a previous incision site was an independent risk factor for PAS disorders. CONCLUSION:The site of placental attachment in patients with placenta previa has an important influence on the pregnancy outcome. When the placenta is located on the anterior wall, clinicians should pay attention to the adverse pregnancy outcomes and the possibility of massive postpartum hemorrhage. In cases of placental attachment to the uterine incision site, physicians should be highly vigilant regarding the occurrence of PAS disorders.

Dataset Information

Intrauterine double-balloon tamponade vs gauze packing in the management of placenta previa: A multicentre randomized controlled trial.

Background

Methods

Results

Publications

Intrauterine double-balloon tamponade vs gauze packing in the management of placenta previa: A multicentre randomized controlled trial.

Similar Datasets

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