Predictive factors for massive bleeding in women with restrained contraception: a prospective study

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patients

We enrolled women diagnosed with RPOC between February 2017 and May 2020 at Nagoya University Hospital, Nagoya, Japan. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki and by the Nagoya University Hospital Institutional Review Board (#2016-0448). All patients included in this study gave written informed consent.

RPOC was diagnosed by transvaginal ultrasonography as persistent intrauterine tissue after spontaneous or induced abortion or delivery. The diagnosis was confirmed with other diagnostic imaging methods such as three-dimensional computed tomography when inconclusive. Massive bleeding was defined as the presence of active bleeding and at least one of the following symptoms: unconsciousness, shock index greater than 1, or serum hemoglobin (Hb) levels

endpoints

The primary endpoint was to validate the utility of PDCS as a predictive factor for major bleeding in women with RPOC. The secondary endpoint was the identification and assessment of other potential predictive factors.

protocol

Women with RPOC were placed on watchful waiting unless they experienced profuse bleeding. Wait-and-see management is defined as a cautious “watch” approach. Massive bleeding was treated with UAE and/or HR. UAE before HR was performed because HR would be limited by massive bleeding, creating poor visual fields and increasing the risk of bleeding from the hypervascular uterus. HR was also performed for nonbleeding but persistent residual tumors ≥ 2 cm in size. Complete resolution was defined as no evidence of RPOC on transvaginal ultrasound and complete regression (

sonography

RPOC was diagnosed based on the presence of a measurable focus of hyperechoic material within the endometrial cavity on two-dimensional grayscale transvaginal ultrasonography. A subjective qualitative assessment of the flow within the RPOC was performed. Transvaginal ultrasound settings have been adjusted to allow maximum sensitivity to blood flow. The ultrasound frequency was set to 8.0 MHz and the power Doppler gain was reduced until the artifacts disappeared.

Previous reports have suggested the use of a subjective semi-quantitative assessment of blood flow to describe vascular features17,18,20,21. In this study, PDCS was used to describe the amount of blood flow to residual tissue. PDCS ranges from a score of 1 to 4, with a score of 1, 2, 3, and 4 indicating no detectable blood flow, minimal flow, moderate flow, and strong vascular flow, respectively17,18,21. The PDCS relates only to the color Doppler image and not to the Doppler shift spectrum.

Statistical analysis

Data were compared between women who did not experience major bleeding and those who did (no bleeding group vs. bleeding group). Continuous variables are presented as medians with minimum and maximum ranges and analyzed using the Mann-Whitney U test. Categorical variables are presented as frequencies with proportions and analyzed using Fisher’s exact test. Receiver operating characteristic (ROC) curves and area under the curve (AUC) were calculated for a preliminary analysis to determine the optimal cut-off for each predictive factor for massive bleeding. For the main analysis, we performed logistic regression analysis to estimate the odds ratio (OR) with a 95% confidence interval (CI) of the predictive factors for major bleeds. Due to the small number of cases, the logistic regression model was corrected using Firth’s method and four models were created for multivariate analysis. In addition, a decision tree analysis was performed to assess predictive factors from multiple perspectives. In all analyses, a P a value

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