Development and Evaluation of Somali-adapted Mindfetalness

Sophiahemmet University

Status: Completed

Conditions: Prevention

Treatments: Behavioral: Modified Mindfetalness

Study type: Interventional

Funder types: Other

Identifiers

NCT05540639

Somali-adapted Mindfetalness

Details and patient eligibility

About

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)

Full 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.

Enrollment: 5,628 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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5,628 participants in 2 patient groups

Intervention with modified Mindfetalness

Experimental group

Description:

The pregnant woman will be informed about the possibility of practicing Mindfetalness verbally, by a video, in a leaflet and at a website. The practice is described as spending 15 minutes every day from gestational week 28+0 to get to know the fetal movement pattern. The fetus must be awake when practicing Mindfetalness and the woman is suggested to lay on her left side when she observes fetal movements. In the leaflet the woman can write down something about the nature, frequency or strength of the fetal movements. If the woman experiences decreased frequency of fetal movements or weaker movements she is instructed to seek healthcare without unnecessary delay.

Treatment:

Behavioral: Modified Mindfetalness

Routine care

No Intervention group

Description:

Historical comparison of the maternal clinics before the intervention. No activities have been taken place.