Development and Evaluation of Somali-adapted Mindfetalness

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)

Study Overview

• Status: Recruiting
• Conditions: Prevention
• Intervention / Treatment: Behavioral: Modified Mindfetalness

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.

• Study Type: Interventional
• Enrollment (Estimated): 5628
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ingela Rådestad, Professor; Phone Number: +46 72 252 00 10; Email: ingela.radestad@shh.se
• Study Contact Backup: Name: Anna Akselsson, PhD; Email: anna.akselsson@shh.se

Study Locations

• Sweden
  • Stockholm, Sweden, 11643
    • Recruiting
    • Ingela Rådestad
    • Contact: Ingela Rådestad; Email: ingela.radestad@shh.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention with modified Mindfetalness; 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; The pregnant woman is motivated to practice Mindfetalness verbally, by video, by a leaflet and at a website.
No Intervention: Routine care; Historical comparison of the maternal clinics before the intervention. No activities have been taken place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apgar score <4	The investigators will use the information reported to the Swedish Pregnancy Register.	At delivery, five minutes after birth
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

Collaborators and Investigators

• Sponsor: Sophiahemmet University
• Collaborators: Karolinska Institutet; Dalarna University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Somali-adapted Mindfetalness

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No