跳至主要内容
临床试验/NCT04823104
NCT04823104终止不适用

Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
105
试验地点
2
主要终点
adequate pregnancy follow-up according to the French recommendations

研究概览

简要总结

Pregnant women who live in rural area have fewer prenatal consultations. It has been demonstrated that maternal and neonatal morbidity and mortality increase if time travel to a maternity ward is longer than 30 min.

Home visitation in isolated area may improve prenatal follow-up as it gives full access to women to health care professionals as well as biological and ultrasound exams without travelling.

Our aim is to assess the impact of home visitation on prenatal follow-up as compared to prenatal follow-up in maternity ward and in primary care.

Isolated areas will be randomized, for women living in areas included in the intervention group, home visitations will be planned for prenatal follow-up. Ultrasound screening as well as blood exams will be performed during home visitations. For women living in control areas, they will be free to choose prenatal follow-up modalities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • At the first antenatal consultation, confirming the pregnancy.
  • Pregnant women who live in an area of geographic vulnerability covered by a perinatal network
  • The women must be informed about the study, understand, read, and speak French, and must be able to consent to participate in medical research

排除标准

  • Pregnant women who live outside an area of geographic vulnerability covered by a perinatal network
  • Women who give birth in a maternity ward outside Auvergne
  • Women from another region giving birth in a maternity ward in Auvergne

结局指标

主要结局

adequate pregnancy follow-up according to the French recommendations

时间窗: 9 months

number of consultations, In all, 8 consultations should take place in a pregnancy that goes to term

次要结局

  • adverse neonatal outcome(9 months)
  • adverse maternal outcome(10 months)
  • economic analyse of the intervention(24 months)
  • Adherence to antenatal care consultations of women(9 months)
  • Adherence to antenatal care complementary exams of women by the mobile antenatal care clinic(9 months)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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