Pregnancy Outcomes Clinical Trial
Official title:
Empowering Women to Shorten Pre-hospital Delay After Decreased Fetal Movements and Simultaneously Lower the Frequency of Unwarranted Visits - a Randomized Study
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.
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.
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