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临床试验/NCT04664660
NCT04664660Unknown不适用

Endometriosis and Risk Factors in Pregnancy, Labor and Delivery

Azienda Ospedaliero-Universitaria di Modena1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2020年3月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
350
试验地点
1
主要终点
Gestational diabetes

研究概览

简要总结

The purpose of this study is to assess if endometriosis can be considered a risk factor for adverse obstetric and delivery outcomes

详细描述

This is a retrospective, observational, case-control study. Pregnancy, delivery and neonatal outcomes will be analyzed in two groups of patients (case and control group): women with diagnosis of endometriosis histologically confirmed and women without endometriosis. Women with endometriosis will be matched to controls by age. A database with general medical and gynecological history, pregnancy course, delivery mode and newborn conditions will be analyzed.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant women who delivered at Azienda Ospedaliero Universitaria Policlinico di Modena from 2000 to 2020
  • Histologic diagnosis of endometriosis before pregnancy for case group
  • Age matched healthy patients for control group

排除标准

  • Clinical records not available

结局指标

主要结局

Gestational diabetes

时间窗: after 18 weeks' pregnancy

fasting blood glucose \>17 mmol/L

Postpartum hemorrhage

时间窗: Time of delivery

Greater than 500 mL estimated blood loss in a vaginal delivery or greater than 1000 mL estimated blood loss at the time of cesarean delivery

Birth-weight

时间窗: Time of delivery

small for gestational age (birth weight below the 10th percentile) or large for gestational age (birth weight over the 90th percentile)

Preterm delivery

时间窗: Time of delivery

Incidence of delivery before 37 weeks of pregnancy

Gestational hypertension

时间窗: after 20 weeks' gestation

blood pressure persistently \> 140/90 mm Hg

Assisted reproduction technologies

时间窗: before pregnancy

Patients who referred to assisted reproduction technologies

Cesarean Section

时间窗: Time of delivery

Robson Classifications

Apgar scores

时间窗: Time of delivery

Apgar scores

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

Carlo Alboni, MD, PhD

Dr. Carlo Alboni MD, PhD Head of Minimally Invasive and Robotic Gynecologic Surgery Unit University Hospital of Modena - Italy

Azienda Ospedaliero-Universitaria di Modena

研究点 (1)

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