NCT02865759

Brief Summary

To improve pregnancy outcome, 39 000 pregnant women will be randomized to receive information about Mindfetalness or to routine care. The level of randomization will be the antenatal clinics in the Stockholm area.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

August 9, 2016

Last Update Submit

July 18, 2020

Conditions

Pregnancy Outcomes

Outcome Measures

Primary Outcomes (3)

  • An Apgar Score below 7

    We will use the score assessed in routine care and reported to the Pregnancy Register.

    Five minutes after birth

  • Caesarian section

    We will use the information in the Pregnancy Register. The responsible health-care professionals clasify the 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

  • Induction of Labor

    We will use the information in the Pregnancy Register. The responsible health-care professionals clasify the 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 Outcomes (1)

  • Visit to health care due to worry about decrease in fetal movements

    Pregnancy from week 28

Other Outcomes (2)

  • An Apgar Score below 4

    Five minutes after birth

  • An Apgar Score below 10

    Five minutes after birth

Study Arms (2)

Mindfetalness

EXPERIMENTAL

The pregnant woman will be informed about the possibility of practicing Mindfetalness verbally, in a brochure and at a website. The practice is described as spending 15 minutes every day from gestational week 28 to get to know the fetal movement pattern. The fetus must be awake when she practice Mindfetalness and the woman is suggested to lay on her left side when she observe the fetal movements. In the brochure as well at the website 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 health-care without unnecessary delay.

Behavioral: Mindfetalness

Routine Care

NO INTERVENTION

No activities will take place in the antenatal clinics randomized to routine care.

Interventions

MindfetalnessBEHAVIORAL

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

Mindfetalness

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant woman with a fetus being at least 25 weeks old (gestational age)
  • Having a Swedish personal identity number

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm region

Stockholm, Sweden

Location

Related Publications (8)

  • Malm MC, Radestad I, Rubertsson C, Hildingsson I, Lindgren H. Women's experiences of two different self-assessment methods for monitoring fetal movements in full-term pregnancy--a crossover trial. BMC Pregnancy Childbirth. 2014 Oct 7;14:349. doi: 10.1186/1471-2393-14-349.

    PMID: 25288075BACKGROUND

  • Radestad I. Strengthening mindfetalness. Sex Reprod Healthc. 2012 Jun;3(2):59-60. doi: 10.1016/j.srhc.2012.01.002. Epub 2012 Jan 27.

    PMID: 22578751BACKGROUND

  • Radestad I, Akselsson A, Georgsson S, Lindgren H, Pettersson K, Steineck G. Rationale, study protocol and the cluster randomization process in a controlled trial including 40,000 women investigating the effects of mindfetalness. Sex Reprod Healthc. 2016 Dec;10:56-61. doi: 10.1016/j.srhc.2016.10.004. Epub 2016 Oct 26.

    PMID: 27938874BACKGROUND

  • Akselsson A, Georgsson S, Lindgren H, Pettersson K, Radestad I. Women's attitudes, experiences and compliance concerning the use of Mindfetalness- a method for systematic observation of fetal movements in late pregnancy. BMC Pregnancy Childbirth. 2017 Oct 16;17(1):359. doi: 10.1186/s12884-017-1548-5.

    PMID: 29037234BACKGROUND

  • Akselsson A, Lindgren H, Georgsson S, Pettersson K, Steineck G, Skokic V, Radestad I. Mindfetalness to increase women's awareness of fetal movements and pregnancy outcomes: a cluster-randomised controlled trial including 39 865 women. BJOG. 2020 Jun;127(7):829-837. doi: 10.1111/1471-0528.16104. Epub 2020 Feb 8.

    PMID: 31971325RESULT

  • Lindgren H, Radestad I, Pettersson K, Skokic V, Akselsson A. Epidural use among women with spontaneous onset of labour - an observational study using data from a cluster-randomised controlled trial. Midwifery. 2021 Dec;103:103156. doi: 10.1016/j.midw.2021.103156. Epub 2021 Sep 30.

    PMID: 34634721DERIVED

  • Radestad I, Pettersson K, Lindgren H, Skokic V, Akselsson A. Country of birth, educational level and other predictors of seeking care due to decreased fetal movements: an observational study in Sweden using data from a cluster-randomised controlled trial. BMJ Open. 2021 Jun 25;11(6):e050621. doi: 10.1136/bmjopen-2021-050621.

    PMID: 34172554DERIVED

  • Akselsson A, Lindgren H, Skokic V, Radestad I. A decrease in cesarean sections and labor inductions among Swedish women by awareness of fetal movements with the Mindfetalness method. BMC Pregnancy Childbirth. 2020 Oct 1;20(1):577. doi: 10.1186/s12884-020-03268-1.

    PMID: 32998708DERIVED

Related Links

Study Officials

  • Ingela Rådestad, PhD

    Sophiahemmet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 12, 2016

Study Start

November 1, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)