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临床试验/NCT04588597
NCT04588597Unknown不适用

Obstetric and Neonatal Outcomes of Twin Pregnancy (Twin Conception-To-Birth): A Multicenter International Study

Assiut University0 个研究点目标入组 300 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
主要终点
Postpartum hemorrhage

研究概览

简要总结

This multicenter study aims at assessing the natural history of twin pregnancy and developing a machine learning-based algorithm to predict clinical outcomes of twin pregnancy during pregnancy and delivery and to determine management strategies that are associated with best maternal and neonatal outcomes. This study will include at least 12 centers from different countries that present at least Europe, South America, Asia, and Africa. Data will be retrospectively collected from January 1st, 2010 to December 31st, 2019.

详细描述

Twin pregnancies carry higher risks of maternal, fetal and neonatal adverse outcomes compared to singleton pregnancy.They are associated with increased perinatal morbidity and mortality, anemia, pregnancy- induced hypertension, increased incidence of cesarean section (CS), postpartum hemorrhage, prematurity and low birth weight and Increased rate of perinatal death.

This multicenter study aims at assessing the natural history of twin pregnancy, and developing a machine learning-based algorithm to predict clinical outcomes of twin pregnancy during pregnancy and delivery and to determine management strategies that are associated with best maternal and neonatal outcomes.

Medical records of eligible women will be reviewed, and data abstraction will be performed using a standardized excel sheet designed for this study. Target data include baseline demographics and clinical data (e.g. age, parity, ethnicity, smoking, IVF pregnancy, history of gynecologic surgeries, type of twin pregnancy, current medical disorders, current obstetric complications, fetal anomalies, administration of antenatal steroids, Placental site, and twin-specific complications). Information from serial ultrasound reports including fetal growth and Doppler studies will be collected and data on fetal intervention will be abstracted. Peripartum data include node of delivery, Method of induction, CS indication, and type of cesarean incision. Clinical outcomes include postpartum hemorrhage, and perinatal death, admission to neonatal intensive care unit (NICU), neonatal need for respiratory support, neonatal intracranial hemorrhage, neonatal respiratory distress syndrome and neonatal hypoxic ischemic encephalopathy. Data will not include any identifiable information.

Prediction model will be created using baseline demographic and obstetric features of pregnancy and individual maternal and perinatal complications will be set as outcomes (dependent variables). A composite outcome of major maternal and neonatal outcomes will be created separately.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with twin pregnancy who received their antenatal care and were delivered in the participating institute
  • Compliance to antenatal care visits

排除标准

  • Major fetal anomalies of one or both twins
  • Elective miscarriage
  • Authorization to use medical records was not provided by the patient

结局指标

主要结局

Postpartum hemorrhage

时间窗: From delivery of the baby to 24 hours postoperative (Total of 24 hours)

Significant uterine bleeding \> 1000 ml

Admission to neonatal intensive care unit (NICU)

时间窗: From delivery of the baby to 24 hours postoperative (Total of 24 hours)

Admission of the baby to NICU for observation or intervention

perinatal death

时间窗: From onset of labor to 1 week postnatal

Death of the baby during delivery or early neonatal period

Intrauterine fetal death

时间窗: Death of the fetus any time from 24 weeks to onset of labor

次要结局

未报告次要终点

研究者

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

Sherif Abdelkarim Mohammed Shazly

M.B.B.Ch, M.S.c in Gynecology and Obstetrics

Assiut University

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