MOGGE PAR-A and PAR-P Scores for Prediction of Adverse Outcomes of Placenta Accreta Spectrum: A Multi-center International Validation Study Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Number of mothers admitted to intensive care unit
研究概览
简要总结
Placenta accreta spectrum (PAS) is a set of placentation disorders that are associated with trophoblastic invasion through the physiologic decidual-myometrial junction zone. PAS may be associated with massive obstetric hemorrhage, surgical injuries, maternal intensive care unit (ICU) admission, reoperation, and prolonged hospitalization.
This study aims at estimating the validity of "MOGGE placenta accreta risk-antepartum score" or "MOGGE PAR-A score" in predicting potential outcomes once PAS is diagnosed antenatally. In addition, it evaluates the validity of "MOGGE placenta accreta risk-peripartum score" or "MOGGE PAR-P score" in calculating the probability of the same outcomes using baseline features in conjugation with both disease-and surgery-related peripartum variables,thereby,assist designation of the most suitable management. Finally , MOGGE CON-PAS score was created for the subgroup of women who were subject to conservative management to predict probability of uterine preservation success.
详细描述
Incidence of PAS has significantly increased in concordance with rising trend of cesarean section delivery (CS) among contemporary population.
Although cesarean hysterectomy, without trying to separate placenta (placenta in-situ), is the standard management of PAS, uterine preservation may be routinely offered to women who are concerned about preserving their uteri and may be considered the primary approach in many institutes all over the world.
The "Placenta Accreta Spectrum International Database (PAS-ID)" is an international database that was launched by Middle-East Obstetrics and Gynaecology Graduate Education (MOGGE) Foundation to conduct the current study.
Eligible patients ,with criteria mentioned in following sections, will be counseled on participation by one of the research team. They will be added to study database by an independent investigator(observing investigator) who will collect baseline data and calculate MOGGE PAR-A score using MOGGE PAR score 1.0 software (available at: https://www.mogge-obgyn.com/clinical-studies). The observing investigator will continue to collect clinical data in subsequent visits, through delivery and postpartum visit to calculate MOGGE PAR-P score at the end of follow-up. If patient management involves a uterus preserving procedure, MOGGE CON-PAS score will be calculated as well(it will be available at: https://www.mogge-obgyn.com/clinical-studies). The observing investigator should not be a part of patients'clinical care team, which should be blinded to the calculated scores. data will be collected using an excel spreadsheet designed for this study. Concerned data include patient age, parity, body mass index,smoking, ethnicity, previous gynecologic surgeries, obstetric complications, gestational age at diagnosis and delivery(in weeks), method of diagnosis, administration of antenatal steroids, indication of delivery, pre-delivery and post-delivery hemoglobin (g/dl), operative management, placental site, degree of placental invasion, type of cesarean incision and its relation to the placenta, intra-operative and postoperative complications, intra-operative blood loss in ml, and transfusion of blood products
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with suspected Placenta Accreta Spectrum (PAS),confirmed by clinical and/ or histo-pathological findings.
- •They must be planned to deliver in one of centers recruited in this study.
排除标准
- •Women who reject participation or whose diagnosis with PAS is eventually excluded based on clinical and/or histo-pathological findings.
结局指标
主要结局
Number of mothers admitted to intensive care unit
时间窗: From skin incision to 24 hours postoperative (Total of 24 hours)
Admission to intensive care unit after delivery
Number of women who experience placenta accreta spectrum related massive blood loss
时间窗: From skin incision to 24 hours postoperative (Total of 24 hours)
Blood loss \> 2500 ml or intra-operative disseminated intravscular coagulopathy (DIC) or transfusion of 10 or more packed red blood cell units
Days of maternal hospitalization after delivery
时间窗: From Cesarean delivery till hospital discharge (Assessment up to 6 weeks)
Maternal admission to hospital for more than 7 days after delivery
次要结局
未报告次要终点
研究者
Sherif Abdelkarim Mohammed Shazly
M.B.B.Ch, M.S.c in Gynecology and Obstetrics
Assiut University