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Completed

NCT Number: NCT05540639

Development and Evaluation of Somali-adapted Mindfetalness

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)

Completed

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Key information

Conditions

Prevention

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ingela Rådestad

Stockholm, 11643, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Modified Mindfetalness

Behavioral

The pregnant woman is motivated to practice Mindfetalness verbally, by video, by a leaflet and at a website.

Primary outcomes

  1. Seeking care due to decreased fetal movements

    Time frame: 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.

  2. Apgar score <10

    Time frame: At delivery, five minutes after birth

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

  3. Apgar score <7

    Time frame: At delivery, five minutes after birth

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

Secondary outcomes

  1. Induction of labour

    Time frame: At delivery

    The investigators will use the information reported to the Swedish Pregnancy Register. The responsible healthcare professionals classify mode of delivery and report it to the register. The register is population-based and covers by and large every birth in the region at the time.

  2. Cesarean section (planned)

    Time frame: At delivery

    The investigators will use the information reported to the Swedish Pregnancy Register. The responsible healthcare professionals classify mode of delivery and report it to the register. The register is population-based and covers by and large every birth in the region at the time.

  3. Cesarean section (emergency)

    Time frame: At delivery

    The investigators will use the information reported to the Swedish Pregnancy Register. The responsible healthcare professionals classify mode of delivery and report it to the register. The register is population-based and covers by and large every birth in the region at the time.

  4. Transfer to Neonatal Intensive Care Unit (NICU)

    Time frame: At delivery

    The investigators will use the Swedish Neonatal Quality Register. The responsible healthcare professionals report transfer to NICU to the register. The register is population-based and covers by and large every birth in the region at the time.

Other outcomes

  1. Apgar score <4

    Time frame: At delivery, five minutes after birth

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

  2. Spontaneous start of labour

    Time frame: At delivery

    The investigators will use the information reported to the Swedish Pregnancy Register. The responsible healthcare professionals classify mode of delivery and report it to the register. The register is population-based and covers by and large every birth in the region at the time.

Sponsors and collaborators

Lead sponsor

Sophiahemmet University

Other

Collaborators

  • Dalarna University
  • Karolinska Institutet

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2022
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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