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临床试验/NCT06220760
NCT06220760已完成不适用

Outcomes of Placenta Accreta Spectrum Disorders Surgery in Relation to Placenta Accreta Scoring Index

Assiut University1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2024年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
1
主要终点
to decide If placenta accreta index (PAI) can predict suitable type of operation needed whether Conservative management/fertility-sparing techniques or Caesarean hysterectomy

研究概览

简要总结

Using of Ultra sound in assessment of Placenta Accreta Index to predict the surgical outcomes of Placenta accreta

详细描述

Placenta accreta is a substantially life-threatening condition and one of the causes of maternal morbidity and mortality in the world. According to study done in United Kingdom, The estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities overall and 577 per 10,000 in women with both a previous caesarean delivery and placenta previa [1]. in a tertiary south Italian center, The incidence increased from 0.12% during the 1970s, to 0.31% during the 2000s [2].While in USA, the prevalence of placenta accreta was 3.7 per 1000 deliveries [3].

This increase is due to many factors. A scar of previous uterine surgery is a major risk factor for placenta accreta. Caesarean section scar is the most common one of uterine scars according to [4] especially in presence of placenta previa where the risk of placenta accreta was 3%, 11%, 40%, 61%, and 67% for the first, second, third, fourth, and fifth or greater repeat cesarean deliveries, respectively. [5] reported that both cesarean delivery morbidity and placenta accreta were positively associated with age >30 years. Previous myomectomy, multi parity, vigorous curettage are other risk factors as said [6]. More ever sub mucous leiomyoma and thermal ablation are also contributing factors to Placenta accreta [7] and lastly [8] said that uterine artery embolization is considered as a risk factor for occurrence of placenta accreta. Contrarily, inter pregnancy interval more than 60 months was associated with decreased risk of placenta accreta [9].

Because placenta accreta can lead to life-threatening blood loss, identification of these high-risk patients would be helpful in management of the pregnancy in addition to enabling the surgeon to be prepared adequately before the time of delivery. Many studies have been done on identification of placenta accreta in the third trimester by 2D ultrasound and color Doppler. There are many modalities for detection of placenta accreta ante natally [10] used 2D ultrasound and color doppler for detection of placenta accreta in 3rd trimester with sensitivity and specificity; 95.24% and 94.74% respectively for ultrasound with the most prominent feature presence of multiple lakes that represented dilated vessels extending from the placenta through the myometrium. For Doppler, the most prominent feature was the presence of interphase hypervascularity with abnormal vessels linking the placenta to the bladder, and the rate was 95.24%.

As for surgery for placenta accreta, planned caesarean hysterectomy is recommended to reduce mortality and morbidity, but fertility is lost. Antenatal diagnosis of placenta accreta spectrum (PAS) can ensure multidisciplinary management at center of excellence which can reduce maternal and fetal complications. This can be established by a scoring system which provides a standardized criterion for the diagnosis and management Placenta Accreta Index (PAI).

Instead of adhering to the conventional approach that involves an elective caesarean hysterectomy based on antenatal imaging, more suitable approaches should be considered from the spectrum of hemostatic and fertility-preserving options available. In our study we will investigate if the degree of adherence is related to the PAI score. Therefore, we can predict cases which will need conservative surgery or peripartum hysterectomy. And so that the surgeon be preplanned to do either hysterectomy or conservative surgery

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women with gestational age 32 weeks or more
  • singleton pregnancy
  • known to have placenta previa (lower edge of the placenta within 5 cm from internal Os )
  • with at least previous 1 cesarean section

排除标准

  • the patient is active in labor
  • haemodynamically unstable

结局指标

主要结局

to decide If placenta accreta index (PAI) can predict suitable type of operation needed whether Conservative management/fertility-sparing techniques or Caesarean hysterectomy

时间窗: 23 months

次要结局

  • Incidence of fetal complication associated with placenta accreta(23 months)
  • The need for ICU admission after placenta accreta surgery and its duration(23 months)
  • Incidence of maternal complications associated with placenta accreta(23 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Nagy Zaki

Clinical professor

Assiut University

研究点 (1)

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