Clinical trial NCT05540639: Development and Evaluation of Somali-adapted Mindfetalness
Official title: Development and Evaluation of Somali-adapted Mindfetalness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention
Lead sponsor: Sophiahemmet University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Dalarna University
First posted: 2022-09-15
Enrollment: 5628
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pregnant women born in Somalia with singleton pregnancy
Primary purpose: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Seeking care due to decreased fetal movements
timeFrame: From pregnancy week 22+0 until birth
measure: Apgar score <10
timeFrame: At delivery, five minutes after birth
measure: Apgar score <7
timeFrame: At delivery, five minutes after birth
Secondary outcomes:
measure: Induction of labour
timeFrame: At delivery
measure: Cesarean section (planned)
timeFrame: At delivery
measure: Cesarean section (emergency)
timeFrame: At delivery
measure: Transfer to Neonatal Intensive Care Unit (NICU)
timeFrame: At delivery
Other outcomes:
measure: Apgar score <4
timeFrame: At delivery, five minutes after birth
measure: Spontaneous start of labour
timeFrame: At delivery
Locations:
city: Stockholm
country: Sweden
facility: Ingela Rådestad
Study officials:
References: