Pregnancy OutcomesMindfetalNCT02865759
Mindfetalness to Improve Pregnancy Outcome
A study testing Mindfetalness in people with Pregnancy Outcomes, run by Sophiahemmet University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Outcomes
- What is being tested?
- Mindfetalness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2016to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant woman with a fetus being at least 25 weeks old (gestational age)
- Having a Swedish personal identity number
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pregnancy Outcomes
- Being tested
- Mindfetalness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfetalnessBehavioural
The pregnant woman is motivated to practice Mindfetalness verbally, by a brochure and at a website.
| Study group | Role | What they receive |
|---|---|---|
| Mindfetalness | Experimental | 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. Receives: Behavioral: Mindfetalness |
| Routine Care | No intervention | No activities will take place in the antenatal clinics randomized to routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
An Apgar Score below 7
We will use the score assessed in routine care and reported to the Pregnancy Register.
Measured: Five minutes after birth
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.
Measured: At delivery
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.
Measured: At delivery.
Secondary outcomes (1)
Visit to health care due to worry about decrease in fetal movements
We will use events registered in the Pregnancy Register.
Measured: Pregnancy from week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start1 Nov 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pregnancy OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sophiahemmet University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Göteborg University
- Responsible party
- Principal investigator, Ingela Radestad, Sophiahemmet University
- Investigators
- Ingela Rådestad, PhD, Principal investigator, Sophiahemmet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865759
- Sponsor's protocol ID
- 2016-2
- Acronym
- Mindfetal
- Status last verified
- Jul 2020
- First submitted
- 9 Aug 2016
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Malm MC, Radestad 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.
PubMed 25288075Radestad I. Strengthening mindfetalness. Sex Reprod Healthc. 2012 Jun;3(2):59-60. doi: 10.1016/j.srhc.2012.01.002. Epub 2012 Jan 27.
PubMed 22578751Radestad 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.
PubMed 27938874Akselsson A, Georgsson S, Lindgren H, Pettersson K, Radestad 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.
PubMed 29037234Akselsson A, Lindgren H, Georgsson S, Pettersson K, Steineck G, Skokic V, Radestad 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):829-837. doi: 10.1111/1471-0528.16104. Epub 2020 Feb 8.
PubMed 31971325Lindgren H, Radestad I, Pettersson K, Skokic V, Akselsson A. Epidural use among women with spontaneous onset of labour - an observational study using data from a cluster-randomised controlled trial. Midwifery. 2021 Dec;103:103156. doi: 10.1016/j.midw.2021.103156. Epub 2021 Sep 30.
PubMed 34634721Radestad I, Pettersson K, Lindgren H, Skokic V, Akselsson A. Country of birth, educational level and other predictors of seeking care due to decreased fetal movements: an observational study in Sweden using data from a cluster-randomised controlled trial. BMJ Open. 2021 Jun 25;11(6):e050621. doi: 10.1136/bmjopen-2021-050621.
PubMed 34172554Akselsson A, Lindgren H, Skokic V, Radestad I. A decrease in cesarean sections and labor inductions among Swedish women by awareness of fetal movements with the Mindfetalness method. BMC Pregnancy Childbirth. 2020 Oct 1;20(1):577. doi: 10.1186/s12884-020-03268-1.
PubMed 32998708
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Women to Shorten Pre-hospital Delay After Decreased Fetal Movements and Simultaneously Lower the Frequency of Unwarranted Visits - a Randomized Study
- ClinicalTrials.gov ID
- NCT02865759
- Acronym / sponsor ID
- Mindfetal / 2016-2
- Conditions
- Pregnancy Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39,000 participants (actual)
- Lead sponsor
- Sophiahemmet UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Göteborg University
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfetalness | Experimental | Behavioral: MindfetalnessThe 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. |
| Routine Care | No intervention | –No activities will take place in the antenatal clinics randomized to routine care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant woman with a fetus being at least 25 weeks old (gestational age)
- Having a Swedish personal identity number
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfetalnessThe pregnant woman is motivated to practice Mindfetalness verbally, by a brochure and at a website. | Behavioural | Mindfetalness |
Primary outcome
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.
Caesarian section
Time frame: 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.
Induction of Labor
Time frame: 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.
1 secondary outcome
Visit to health care due to worry about decrease in fetal movements
Time frame: Pregnancy from week 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Background: PubMed 25288075Malm MC, Radestad 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.
- Background: PubMed 22578751Radestad I. Strengthening mindfetalness. Sex Reprod Healthc. 2012 Jun;3(2):59-60. doi: 10.1016/j.srhc.2012.01.002. Epub 2012 Jan 27.
- Background: PubMed 27938874Radestad 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.
- Background: PubMed 29037234Akselsson A, Georgsson S, Lindgren H, Pettersson K, Radestad 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.
- Results publication: PubMed 31971325Akselsson A, Lindgren H, Georgsson S, Pettersson K, Steineck G, Skokic V, Radestad 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):829-837. doi: 10.1111/1471-0528.16104. Epub 2020 Feb 8.
- Derived from this study: PubMed 34634721Lindgren H, Radestad I, Pettersson K, Skokic V, Akselsson A. Epidural use among women with spontaneous onset of labour - an observational study using data from a cluster-randomised controlled trial. Midwifery. 2021 Dec;103:103156. doi: 10.1016/j.midw.2021.103156. Epub 2021 Sep 30.
- Derived from this study: PubMed 34172554Radestad I, Pettersson K, Lindgren H, Skokic V, Akselsson A. Country of birth, educational level and other predictors of seeking care due to decreased fetal movements: an observational study in Sweden using data from a cluster-randomised controlled trial. BMJ Open. 2021 Jun 25;11(6):e050621. doi: 10.1136/bmjopen-2021-050621.
- Derived from this study: PubMed 32998708Akselsson A, Lindgren H, Skokic V, Radestad I. A decrease in cesarean sections and labor inductions among Swedish women by awareness of fetal movements with the Mindfetalness method. BMC Pregnancy Childbirth. 2020 Oct 1;20(1):577. doi: 10.1186/s12884-020-03268-1.
- A description of the method in 16 different languagesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingela Rådestad, PhD principal investigator
Sophiahemmet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfetalness in people with Pregnancy Outcomes, run by Sophiahemmet University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An Apgar Score below 7 (time frame: Five minutes after birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02865759, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.