Development and Evaluation of Somali-adapted Mindfetalness

Prevention Clinical Trial

Official title:

Development and Evaluation of Somali-adapted Mindfetalness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540639
• Other study ID #: Somali-adapted Mindfetalness
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Sophiahemmet University
• Contact: Ingela Rådestad, Professor
• Phone: +46 72 252 00 10
• Email: ingela.radestad[@]shh.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5628
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Prevention

Intervention

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

Locations

Country	Name	City	State
Sweden	Ingela Rådestad	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Sophiahemmet University	Dalarna University, Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Apgar score <4	The investigators will use the information reported to the Swedish Pregnancy Register.	At delivery, five minutes after birth
Other	Spontaneous start of labour	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.	At delivery
Primary	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
Primary	Apgar score <10	The investigators will use the information reported to the Swedish Pregnancy Register.	At delivery, five minutes after birth
Primary	Apgar score <7	The investigators will use the information reported to the Swedish Pregnancy Register.	At delivery, five minutes after birth
Secondary	Induction of labour	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.	At delivery
Secondary	Cesarean section (planned)	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.	At delivery
Secondary	Cesarean section (emergency)	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.	At delivery
Secondary	Transfer to Neonatal Intensive Care Unit (NICU)	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.	At delivery