Mindfetalness to Improve Pregnancy Outcome

Pregnancy Outcomes Clinical Trial

— Mindfetal  

Official title:

Empowering Women to Shorten Pre-hospital Delay After Decreased Fetal Movements and Simultaneously Lower the Frequency of Unwarranted Visits - a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02865759
• Other study ID #: 2016-2
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2020
• Source: Sophiahemmet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 39000
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant woman with a fetus being at least 25 weeks old (gestational age)

• Having a Swedish personal identity number

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Pregnancy Outcomes

Intervention

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

Locations

Country	Name	City	State
Sweden	Stockholm region	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Sophiahemmet University	Göteborg University, Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View Citation

Akselsson A, Lindgren H, Georgsson S, Pettersson K, Steineck G, Skokic V, Rådestad 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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	An Apgar Score below 4	We will use the score assessed in routine care and reported to the Pregnancy Register.	Five minutes after birth
Other	An Apgar Score below 10	We will use the score assessed in routine care and reported to the Pregnancy Register.	Five minutes after birth
Primary	An Apgar Score below 7	We will use the score assessed in routine care and reported to the Pregnancy Register.	Five minutes after birth
Primary	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
Primary	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	Visit to health care due to worry about decrease in fetal movements	We will use events registered in the Pregnancy Register.	Pregnancy from week 28

External Links

•   A description of the method in 16 different languages