Mindfetalness to Improve Pregnancy Outcome
- Conditions
- Pregnancy Outcomes
- Registration Number
- NCT02865759
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 39000
- Pregnant woman with a fetus being at least 25 weeks old (gestational age)
- Having a Swedish personal identity number
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method An Apgar Score below 7 Five minutes after birth We will use the score assessed in routine care and reported to the Pregnancy Register.
Induction of Labor At delivery. 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.
Caesarian section At delivery 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.
- Secondary Outcome Measures
Name Time Method Visit to health care due to worry about decrease in fetal movements Pregnancy from week 28 We will use events registered in the Pregnancy Register.
Trial Locations
- Locations (1)
Stockholm region
🇸🇪Stockholm, Sweden
Stockholm region🇸🇪Stockholm, Sweden