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Mindfetalness to Improve Pregnancy Outcome (Mindfetal)

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

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 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

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.



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.



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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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865759


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