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Development and Evaluation of Somali-adapted Mindfetalness

Development and Evaluation of Somali-adapted Mindfetalness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05540639
Enrollment
5628
Registered
2022-09-15
Start date
2022-01-11
Completion date
2024-06-30
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention

Brief summary

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)

Detailed description

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.

Interventions

BEHAVIORALModified Mindfetalness

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

Sponsors

Karolinska Institutet
CollaboratorOTHER
Dalarna University
CollaboratorOTHER
Sophiahemmet University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Pregnant women born in Somalia with singleton pregnancy

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Apgar score <10At delivery, five minutes after birthThe investigators will use the information reported to the Swedish Pregnancy Register.
Apgar score <7At delivery, five minutes after birthThe investigators will use the information reported to the Swedish Pregnancy Register.
Seeking care due to decreased fetal movementsFrom pregnancy week 22+0 until birthThe 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.

Secondary

MeasureTime frameDescription
Transfer to Neonatal Intensive Care Unit (NICU)At deliveryThe 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.
Cesarean section (emergency)At deliveryThe 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.
Induction of labourAt deliveryThe 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.
Cesarean section (planned)At deliveryThe 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.

Other

MeasureTime frameDescription
Apgar score <4At delivery, five minutes after birthThe investigators will use the information reported to the Swedish Pregnancy Register.
Spontaneous start of labourAt deliveryThe 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026