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临床试验/NCT05540639
NCT05540639已完成不适用

Development and Evaluation of Somali-adapted Mindfetalness

Sophiahemmet University2 个研究点 分布在 1 个国家目标入组 5,628 人开始时间: 2022年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,628
试验地点
2
主要终点
Seeking care due to decreased fetal movements

研究概览

简要总结

Development of Somali-adapted Mindfetalness: Interviews with women born in Somalia

A before-after study:

Intervention: pregnant women receive a pamphlet, introduction to Mindfetalness by her midwife during the gestational-week 25 visit. The pregnant woman will well get access to a website concerning Mindfetalness. The pregnant women will be encouraged to start practicing Somali-adapted Mindfetalness during gestational week 28.

Comparison: Intervention period (1/1-2022 to 31/12 2023) compared to 5 years before (1/1 2015 to 31/12 2019)

详细描述

Development of Somali-adapted Mindfetalness, initial data collection:

Pregnant women or recently given birth. Women born in Somalia with a singleton pregnancy from gestational week 28+0. Interviews focusing on fetal movements, reactions to fetal movements, and facilitating and inhibiting factors for seeking care for pregnancy-related conditions will be carried out. After transcription verbatim, the text will be analyzed with modified content analysis as described by Elo & Kyngäs.

A before-after study:

Population: Women born in Somalia registered at one of the 31 antenatal clinics where under 2019 ten or more women were registered. The registration will be either 1/1 2022 to 31/12 2023 or 1/1 2015 and 31/12 2019 (1/1 2020 to 31/12 2021 has been omitted to diminish a possible confounding effect of the COVID-19 pandemic.)

Intervention: In the chosen 31 antenatal clinics, midwives will receive an education in Somali-adapted Mindfetalness. Moreover, each pregnant woman registered after 1/1 2022 and before 31/12 2023, will receive a pamphlet, introduction to Mindfetalness by her midwife during the gestational-week 25 visit. The pregnant woman will well get access to a website concerning Mindfetalness. The pregnant women will be encouraged to start practicing Somali-adapted Mindfetalness during gestational week 28.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant woman living in Sweden but born in Somalia, in gestational age minimum 24+0

排除标准

  • 未提供

结局指标

主要结局

Seeking care due to decreased fetal movements

时间窗: From pregnancy week 22+0 until birth

The investigators will use the ICD-code (International Classification of Diseases) AM041 (examination due to decreased fetal movements) where applicable . The Investigators will use the data from The Swedish Pregnancy Register.

Apgar score <10

时间窗: At delivery, five minutes after birth

The investigators will use the information reported to the Swedish Pregnancy Register.

Apgar score <7

时间窗: At delivery, five minutes after birth

The investigators will use the information reported to the Swedish Pregnancy Register.

次要结局

  • Induction of labour(At delivery)
  • Cesarean section (planned)(At delivery)
  • Cesarean section (emergency)(At delivery)
  • Transfer to Neonatal Intensive Care Unit (NICU)(At delivery)

研究者

发起方
Sophiahemmet University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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