Development and Evaluation of Somali-adapted Mindfetalness

NCT05540639 | Completed

• 1 other identifier: Somali-adapted Mindfetalness
• Study Type: interventional
• Target: 5,628
• Locations: 1 country
• Sites: 1

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)

Conditions

Prevention

Outcome Measures

Primary Outcomes (3)

• Seeking care due to decreased fetal movements

  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.

  From pregnancy week 22+0 until birth

• Apgar score <10

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

  At delivery, five minutes after birth

• Apgar score <7

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

  At delivery, five minutes after birth

Secondary Outcomes (4)

• Induction of labour

  At delivery

• Cesarean section (planned)

  At delivery

• Cesarean section (emergency)

  At delivery

• Transfer to Neonatal Intensive Care Unit (NICU)

  At delivery

Other Outcomes (2)

• Apgar score <4

  At delivery, five minutes after birth

• Spontaneous start of labour

  At delivery

Study Arms (2)

Intervention with modified Mindfetalness

EXPERIMENTAL

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.

Behavioral: Modified Mindfetalness

Routine care

NO INTERVENTION

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

Interventions

Modified Mindfetalness BEHAVIORAL

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

Intervention with modified Mindfetalness

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Sophiahemmet University: lead
• Karolinska Institutet: collaborator
• Dalarna University: collaborator

Study Sites (1)

Ingela Rådestad

Stockholm, 11643, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pregnant women born in Somalia with singleton pregnancy

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: September 15, 2022
• Study Start: January 11, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 17, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)