Mindfetalness to Improve Pregnancy Outcome (Mindfetal)

• ClinicalTrials.gov Identifier: NCT02865759
• Recruitment Status: Completed
• First Posted: August 12, 2016
• Last Update Posted: October 2, 2018
• Sponsor: Sophiahemmet University
• Collaborators: Karolinska Institutet; Göteborg University
• Information provided by (Responsible Party): Ingela Radestad, Sophiahemmet University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy Outcomes	Behavioral: Mindfetalness	Not Applicable

Detailed Description:

The investigators have randomized 33 antenatal clinics in Stockholm to the intervention (receiving information about Mindfetalness) and 30 to routine care. The randomization was performed in blocks according to varying yearly volumes of pregnant women and socio-economic residential area. Three small clinics, with a total of 85 women listed in 2015, were not randomized. Another four clinics, receiving referrals of women with need for specialized care, were not randomized either. The recruitment is restricted to the 63 randomized clinics. In a pilot study in one antenatal clinic, the intervention has been tested among 102 women. A run-in period will start at high-volume antenatal clinics 1 September 2016, one month before the investigators start to register the women that will be observed for pregnancy outcome. All information, including that of possible effect-modifying and possible confounding factors, will be fetched from population-based registers and linked by the personal identify number unique for each resident in Sweden. The Swedish Medical Birth Register, Obstetrix, the Swedish Educational Register, the Prescribed Drug Register and the National Patient Register provide the information. By this design, and the analyses according to the intention-to treat principle, attrition and differential misclassification of outcome becomes negligible. Non-differential misclassification of the predictor (Mindfetalness or no Mindfetalness) will be substantial, diluting the effect estimates. This dilution may be compensated by the large size of the trial. Since the unit of randomization is the antenatal clinics residual confounding is an issue. The investigators will have, however, information on important possible confounding factors, including educational level, age, parity, body mass index, country of birth, diabetes mellitus before the pregnancy, certain other pre-pregnancy diseases, previous stillbirth, gestational diabetes mellitus and preeclampsia.

An article describing the study protocol has been published. A pilot study testing complicance of mindfetalness has been published. Data concerning outcome (all recruited women are followed from gestational week 32+0 until delivery) will be exported from the pregnancy register during October 2018.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Empowering Women to Shorten Pre-hospital Delay After Decreased Fetal Movements and Simultaneously Lower the Frequency of Unwarranted Visits - a Randomized Study
• Actual Study Start Date: November 1, 2016
• Actual Primary Completion Date: June 30, 2018
• Actual Study Completion Date: June 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mindfetalness; 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; The pregnant woman is motivated to practice Mindfetalness verbally, by a brochure and at a website.
No Intervention: Routine Care; No activities will take place in the antenatal clinics randomized to routine care.

Outcome Measures

Primary Outcome Measures :

1. An Apgar Score below 7 [ Time Frame: Five minutes after birth ]
   We will use the score assessed in routine care and reported to the Pregnancy Register.

Secondary Outcome Measures :

1. Visit to health care due to worry about decrease in fetal movements [ Time Frame: Pregnancy from week 28 ]
   We will use events registered in the Pregnancy Register.

Other Outcome Measures:

1. An Apgar Score below 4 [ Time Frame: Five minutes after birth ]
   We will use the score assessed in routine care and reported to the Pregnancy Register.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

Sweden

Stockholm region

Stockholm, Sweden

Sponsors and Collaborators

Sophiahemmet University

Karolinska Institutet

Göteborg University

Investigators

• Principal Investigator: Ingela Rådestad, PhD; Sophiahemmet University

  Study Documents (Full-Text)

Documents provided by Ingela Radestad, Sophiahemmet University:

Statistical Analysis Plan  [PDF] September 24, 2018

More Information

Publications:

Malm MC, Rådestad 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.

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

Rådestad 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.

Akselsson A, Georgsson S, Lindgren H, Pettersson K, Rådestad 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.

• Responsible Party: Ingela Radestad, Principal Investigator, Sophiahemmet University
• ClinicalTrials.gov Identifier: NCT02865759
• Other Study ID Numbers: 2016-2
• First Posted: August 12, 2016
• Last Update Posted: October 2, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided