Hypertension, Pregnancy-InducedNCT03873194
Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy
A study testing Meditation and conventional treatment in people with Hypertension, Pregnancy-Induced and Hypertension in Pregnancy, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Pregnancy relates to arterial hypertension; it is an aggravating factor for pre-existing chronic arterial hypertension or a trigger for preeclampsia in normotensive women. The gestational hypertensive disease is managed conventionally with the pregnant woman's hospitalization and/or the use of antihypertensive… Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Hypertension, Pregnancy-Induced, Hypertension in Pregnancy, Hypertension
- What is being tested?
- Meditation and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Apr 2019to 30 Dec 2021
- 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 21 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre-existing hypertension.
- Single pregnancy, with gestational age between 20th and 24th weeks, with uncomplicated systemic arterial hypertension.
- Prenatal follow-up in a high-risk pregnancy clinic.
- No personal background of depression or psychiatric disorders.
- No serious heart disease.
- No illicit drugs and/or alcohol use.
- Acceptance of the informed consent.
- To follow the practice used in the study, the subjects are required to have an available phone in order to download an app which contains an audio guide for this purpose.
Who cannot join
- Diagnosis of depression and psychiatric disorders during pregnancy.
- Patients who do not return to follow-up or who want to quit the study.
- To practice meditation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403000
About this study
Official title: Use of Meditation as a Complementary Therapy in the Treatment of Gestational Hypertension
Pregnancy relates to arterial hypertension; it is an aggravating factor for pre-existing chronic arterial hypertension or a trigger for preeclampsia in normotensive women. The gestational hypertensive disease is managed conventionally with the pregnant woman's hospitalization and/or the use of antihypertensive medications. Nevertheless, this treatment may present some risks. The investigators seek to determine whether the intervention compared to the control can reduce the increase in blood pressure that pregnant women in the transition from the 2nd to the 3rd trimester.
Read the detailed description
Primary research question:
Can meditation decrease the mean increase in diastolic blood pressure in pregnant hypertensive women at the transition from the second to the third trimester of gestation?
Secondary research question:
Can meditation decrease the mean increase in systolic blood pressure in pregnant hypertensive women at the transition from the second to the third trimester of gestation?
Does meditation practice increases (or decreases) the likelihood of change in Resilience indicators?
Does meditation practice increase (or decrease) the likelihood of change in anxiety and depression indicators?
Does meditation practice increase (or decrease) the likelihood of change in mindfulness indicators?
Does meditation practice increase (or decrease) the likelihood of change in quality of life indicators?
- Being tested
- Meditation, conventional treatment
- Keywords
- systemic arterial hypertension, hypertension, hypertension, pregnancy-induced, pre-eclampsia, meditation, randomized clinical Trial
- Medical subject headings
- Hypertension, Pregnancy-Induced, Hypertension, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationOther
Participants will be instructed to find a comfortable position, with a straight back, feeling the general state of their bodies (tensions, pains, heat, cold, etc.), to relax and pay attention to their own breathing, being aware of the air that gets into and out of the lungs. The women will be told that whenever their attention disperses (to another focus such as a thought, a sound, a body sensation, a judgment, etc.) they should go back to the original focus (breathing) with no feeling/judgment about the loss of focus. The practice involves focus and attention exercises and the gradual insertion of other anchors (focus points) as participants improve their skills in this practice.
conventional treatmentOther
Early prenatal care, when possible, is recommended as the first measure. Prenatal appointments usually take place fortnightly or weekly for hypertensive pregnant women. Extensive lab testing including specific tests for the first trimester, as well as tests for the diagnosis of superimposed pre-eclampsia and for the evaluation of lesions in target organs.
Drug treatment is only used when non-drug measures against hypertension are inefficient to decrease blood pressure levels and diastolic pressure is 90 mmHg or higher (in the first half of pregnancy) and over 100 mmHg (after 20 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Meditation group | Experimental | Patients who are going to practice meditation and will receive only the usual outpatient care, with the aim of observing reduction of systemic blood pressure in this period. Receives: Other: Meditation; Other: conventional treatment |
| conventional treatment | Other | Patients that will receive only the usual outpatient care, with the aim of observing the systemic blood pressure in this period. Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison the means of diastolic blood pressure of pregnant women's between intervention group and control group.
Diastolic blood pressure control in pregnant women with chronic hypertension between intervention group (meditation practice) and control group, in the transition from the second to the third trimester of pregnancy, when there is a physiologic increase in arterial pressure.
The diastolic pressure check will be in outpatient consultation with intervals of 15 days, during 8 weeks.
The device used for checking the pressure will be the GAMMA XXL LF of Heine General Medicine.
All blood pressure checks either in the intervention group or control group will be performed on the same device.
Measured: 8 weeks
Comparison the means of systolic blood pressure of pregnant women's between intervention group and control group.
Systolic blood pressure control in pregnant women with chronic hypertension between intervention group (meditation practice) and control group, in the transition from the second to the third trimester of pregnancy, when there is a physiologic increase in arterial pressure.
The systolic pressure check will be in outpatient consultation with intervals of 15 days, during.
The device used for checking the pressure will be the GAMMA XXL LF of Heine General Medicine.
All blood pressure checks either in the intervention group or control group will be performed on the same device.
Measured: 8 weeks
Secondary outcomes (4)
Assessment of quality of life with World Health Organization instrument for evaluating quality of life (Whoqol-bref) questionnaire.
Checking potential increases or decreases in the quality life indicator during pregnancy using the Whoqol-Bref questionnaire as a result measure.
The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks.
This questionnaire is composed of four domains of quality of life, totaling 24 questions.
The answers follow a Likert scale (from 1 to 5) and the domain scores for the WHOQOL-BREF were calculated by multiplying the mean of all items included within the domain by four. Potential scores for all domain scores, therefore, range from 4-20.
Only the total quality of life score will be considered in this study. For this study, a larger score on the Whoqol-Bref demonstrates a better outcome for the group performing the meditation intervention.
Measured: 8 weeks
Assessment of anxiety and depression with The Hospital Anxiety and Depression Scale (HADS).
Checking potential increase or decreases of anxiety and depression indicators during pregnancy using the HADS Scale as a result measure.
The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks.
The Hospital Anxiety and Depression Scale (HADS) consist of 14 questions. It was divided into an Anxiety subscale (HADS-A) consist of 07 questions and a Depression subscale (HADS-D) consist of 07 questions both containing seven intermingled items.
Each items can be scored from zero (0) to three (3), composing a maximum score of 21 points for each sub-scale.
- HAD-anxiety: no anxiety from 0 to 8, with anxiety ≥ 9;
- HAD-depression: without depression from 0 to 8, with depression ≥ 9.
For this study, a larger score on the Resilience Scale demonstrates a worst outcome for the group performing the meditation intervention.
Measured: 8 weeks
Assessment of the capacity to adapt and restore equilibrium to their lives and avoid the potentially deleterious effects of stress with Resilience Scale.
Checking potential increase or decreases of the capacity to adapt and restore equilibrium to their lives and avoid the potentially deleterious effects of stress, during pregnancy using the Resilience Scale as a result measure.
The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks.
The Resilience Scale is the scale that consist of 25 questions concerning the capacity to adapt and restore equilibrium to their lives to be rated on a 7-point scale
The Likert scale ranged from (1) disagree to (7) agree, with higher scores reflecting higher levels of trait mindfulness.
Possible scores range from 25 to 175 with higher scores reflecting higher resilience.
For this study, a larger score on the Resilience Scale demonstrates a better outcome for the group performing the meditation intervention.
Measured: 8 weeks
Assessment on the presence or absence of attention to and awareness of what is occurring in the present, that differentiates meditation practitioners from others, with Mindful Attention Awareness Scale (MAAS)
Checking potential increase or decreases on the presence or absence of attention to and awareness of what is occurring in the present, that differentiates meditation practitioners from others, during pregnancy using the MAAS as a result measure.
The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks.
The Mindful Attention Awareness Scale is the unidimensional scale that consists of 15 questions concerning attention or awareness in routine situations to be rated on a 6-point scale on how frequently or infrequently the teste experiences those situations.
The Likert scale ranged from (1) almost always to (6) almost never, with higher scores reflecting higher levels of trait mindfulness.
The lowest possible value to be achieved when answering this scale is 15 and the highest possible value is 90.
For this study, a larger score on the MAAS scale demonstrates a better outcome for the group performing the meditation intervention.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start15 Apr 2019
- Primary completion15 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Hypertension, Pregnancy-InducedStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The objective of this study is assess the effect of meditation as a complementary therapy in hypertensive pregnant women. The method used will be a randomized, controlled and blinded clinical trial, where meditation is going to be offered between March 2019 and July 2020 at the Obstetrics Clinic of Hospital of Clinics, Faculty of Medicine, University of São Paulo. Patients are going to be randomly assigned to two groups: Group I, patients who are going to practice meditation and Group II, patients that will receive only the usual outpatient care. The allocation will be performed according to CONSORT criteria and sequential within two classifications of diastolic blood pressure values. Differences between the means of the variables (blood pressure levels and questionnaires about life quality, anxiety, resilience and mindfulness) will be compared between the groups. Values of p\<0,05 will be considered significant.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873194
- Sponsor's protocol ID
- 93028218.7.0000.0068
- Status last verified
- Nov 2020
- First submitted
- 27 Feb 2019
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gow AJ, Bastin ME, Munoz Maniega S, Valdes Hernandez MC, Morris Z, Murray C, Royle NA, Starr JM, Deary IJ, Wardlaw JM. Neuroprotective lifestyles and the aging brain: activity, atrophy, and white matter integrity. Neurology. 2012 Oct 23;79(17):1802-8. doi: 10.1212/WNL.0b013e3182703fd2.
PubMed 23091073Himelstein S. Meditation research: the state of the art in correctional settings. Int J Offender Ther Comp Criminol. 2011 Jun;55(4):646-61. doi: 10.1177/0306624X10364485. Epub 2010 Mar 23.
PubMed 20332328Bernstein PS, Martin JN Jr, Barton JR, Shields LE, Druzin ML, Scavone BM, Frost J, Morton CH, Ruhl C, Slager J, Tsigas EZ, Jaffer S, Menard MK. Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period. J Obstet Gynecol Neonatal Nurs. 2017 Sep-Oct;46(5):776-787. doi: 10.1016/j.jogn.2017.05.003. Epub 2017 Jul 11.
PubMed 28709727Fitton CA, Steiner MFC, Aucott L, Pell JP, Mackay DF, Fleming M, McLay JS. In-utero exposure to antihypertensive medication and neonatal and child health outcomes: a systematic review. J Hypertens. 2017 Nov;35(11):2123-2137. doi: 10.1097/HJH.0000000000001456.
PubMed 28661961Ospina MB, Bond K, Karkhaneh M, Tjosvold L, Vandermeer B, Liang Y, Bialy L, Hooton N, Buscemi N, Dryden DM, Klassen TP. Meditation practices for health: state of the research. Evid Rep Technol Assess (Full Rep). 2007 Jun;(155):1-263.
PubMed 17764203Kozasa EH, Radvany J, Barreiros MA, Leite JR, Amaro E Jr. Preliminary functional magnetic resonance imaging Stroop task results before and after a Zen meditation retreat. Psychiatry Clin Neurosci. 2008 Jun;62(3):366. doi: 10.1111/j.1440-1819.2008.01809.x. No abstract available.
PubMed 18588603Stahl JE, Dossett ML, LaJoie AS, Denninger JW, Mehta DH, Goldman R, Fricchione GL, Benson H. Correction: Relaxation Response and Resiliency Training and Its Effect on Healthcare Resource Utilization. PLoS One. 2017 Feb 21;12(2):e0172874. doi: 10.1371/journal.pone.0172874. eCollection 2017.
PubMed 28222185Mulder EJ, Robles de Medina PG, Huizink AC, Van den Bergh BR, Buitelaar JK, Visser GH. Prenatal maternal stress: effects on pregnancy and the (unborn) child. Early Hum Dev. 2002 Dec;70(1-2):3-14. doi: 10.1016/s0378-3782(02)00075-0.
PubMed 12441200Vieten C, Astin J. Effects of a mindfulness-based intervention during pregnancy on prenatal stress and mood: results of a pilot study. Arch Womens Ment Health. 2008;11(1):67-74. doi: 10.1007/s00737-008-0214-3. Epub 2008 Mar 3.
PubMed 18317710Beddoe AE, Lee KA. Mind-body interventions during pregnancy. J Obstet Gynecol Neonatal Nurs. 2008 Mar-Apr;37(2):165-75. doi: 10.1111/j.1552-6909.2008.00218.x.
PubMed 18336440Beddoe AE, Paul Yang CP, Kennedy HP, Weiss SJ, Lee KA. The effects of mindfulness-based yoga during pregnancy on maternal psychological and physical distress. J Obstet Gynecol Neonatal Nurs. 2009 May-Jun;38(3):310-9. doi: 10.1111/j.1552-6909.2009.01023.x.
PubMed 19538619van den Heuvel MI, Donkers FC, Winkler I, Otte RA, Van den Bergh BR. Maternal mindfulness and anxiety during pregnancy affect infants' neural responses to sounds. Soc Cogn Affect Neurosci. 2015 Mar;10(3):453-60. doi: 10.1093/scan/nsu075. Epub 2014 Jun 12.
PubMed 24925904Narendran S, Nagarathna R, Narendran V, Gunasheela S, Nagendra HR. Efficacy of yoga on pregnancy outcome. J Altern Complement Med. 2005 Apr;11(2):237-44. doi: 10.1089/acm.2005.11.237.
PubMed 15865489Narendran S, Nagarathna R, Gunasheela S, Nagendra HR. Efficacy of yoga in pregnant women with abnormal Doppler study of umbilical and uterine arteries. J Indian Med Assoc. 2005 Jan;103(1):12-4, 16-7.
PubMed 16008324van den Heuvel MI, Johannes MA, Henrichs J, Van den Bergh BR. Maternal mindfulness during pregnancy and infant socio-emotional development and temperament: the mediating role of maternal anxiety. Early Hum Dev. 2015 Feb;91(2):103-8. doi: 10.1016/j.earlhumdev.2014.12.003. Epub 2015 Jan 8.
PubMed 25577496
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Meditation as a Complementary Therapy in the Treatment of Gestational Hypertension
- ClinicalTrials.gov ID
- NCT03873194
- Acronym / sponsor ID
- 93028218.7.0000.0068
- Keywords
- systemic arterial hypertension, hypertension, hypertension, pregnancy-induced, pre-eclampsia, meditation, randomized clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 13 Mar 2019 (actual)
- 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.
Pregnancy relates to arterial hypertension; it is an aggravating factor for pre-existing chronic arterial hypertension or a trigger for preeclampsia in normotensive women. The gestational hypertensive disease is managed conventionally with the pregnant woman's hospitalization and/or the use of antihypertensive medications. Nevertheless, this treatment may present some risks. The investigators seek to determine whether the intervention compared to the control can reduce the increase in blood pressure that pregnant women in the transition from the 2nd to the 3rd trimester.
Detailed description
Primary research question:
Can meditation decrease the mean increase in diastolic blood pressure in pregnant hypertensive women at the transition from the second to the third trimester of gestation?
Secondary research question:
Can meditation decrease the mean increase in systolic blood pressure in pregnant hypertensive women at the transition from the second to the third trimester of gestation?
Does meditation practice increases (or decreases) the likelihood of change in Resilience indicators?
Does meditation practice increase (or decrease) the likelihood of change in anxiety and depression indicators?
Does meditation practice increase (or decrease) the likelihood of change in mindfulness indicators?
Does meditation practice increase (or decrease) the likelihood of change in quality of life indicators?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The objective of this study is assess the effect of meditation as a complementary therapy in hypertensive pregnant women. The method used will be a randomized, controlled and blinded clinical trial, where meditation is going to be offered between March 2019 and July 2020 at the Obstetrics Clinic of Hospital of Clinics, Faculty of Medicine, University of São Paulo. Patients are going to be randomly assigned to two groups: Group I, patients who are going to practice meditation and Group II, patients that will receive only the usual outpatient care. The allocation will be performed according to CONSORT criteria and sequential within two classifications of diastolic blood pressure values. Differences between the means of the variables (blood pressure levels and questionnaires about life quality, anxiety, resilience and mindfulness) will be compared between the groups. Values of p<0,05 will be considered significant.
| Arm | Type | Receives |
|---|---|---|
| Meditation group | Experimental | Other: Meditation, Other: conventional treatmentPatients who are going to practice meditation and will receive only the usual outpatient care, with the aim of observing reduction of systemic blood pressure in this period. |
| conventional treatment | Other | Other: conventional treatmentPatients that will receive only the usual outpatient care, with the aim of observing the systemic blood pressure in this period. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Pre-existing hypertension.
- Single pregnancy, with gestational age between 20th and 24th weeks, with uncomplicated systemic arterial hypertension.
- Prenatal follow-up in a high-risk pregnancy clinic.
- No personal background of depression or psychiatric disorders.
- No serious heart disease.
Key exclusion criteria (3 listed)
- Diagnosis of depression and psychiatric disorders during pregnancy.
- Patients who do not return to follow-up or who want to quit the study.
- To practice meditation.
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 |
|---|---|---|
| MeditationParticipants will be instructed to find a comfortable position, with a straight back, feeling the general state of their bodies (tensions, pains, heat, cold, etc.), to relax and pay attention to their own breathing, being aware of the air that gets into and out of the lungs. The women will be told that whenever their attention disperses (to another focus such as a thought, a sound, a body sensation, a judgment, etc.) they should go back to the original focus (breathing) with no feeling/judgment about the loss of focus. The practice involves focus and attention exercises and the gradual insertion of other anchors (focus points) as participants improve their skills in this practice. | Other | Meditation group |
| conventional treatmentEarly prenatal care, when possible, is recommended as the first measure. Prenatal appointments usually take place fortnightly or weekly for hypertensive pregnant women. Extensive lab testing including specific tests for the first trimester, as well as tests for the diagnosis of superimposed pre-eclampsia and for the evaluation of lesions in target organs. Drug treatment is only used when non-drug measures against hypertension are inefficient to decrease blood pressure levels and diastolic pressure is 90 mmHg or higher (in the first half of pregnancy) and over 100 mmHg (after 20 weeks). | Other | Meditation group, conventional treatment |
Primary outcome
Comparison the means of diastolic blood pressure of pregnant women's between intervention group and control group.
Time frame: 8 weeks
Diastolic blood pressure control in pregnant women with chronic hypertension between intervention group (meditation practice) and control group, in the transition from the second to the third trimester of pregnancy, when there is a physiologic increase in arterial pressure. The diastolic pressure check will be in outpatient consultation with intervals of 15 days, during 8 weeks. The device used for checking the pressure will be the GAMMA XXL LF of Heine General Medicine. All blood pressure checks either in the intervention group or control group will be performed on the same device.
Comparison the means of systolic blood pressure of pregnant women's between intervention group and control group.
Time frame: 8 weeks
Systolic blood pressure control in pregnant women with chronic hypertension between intervention group (meditation practice) and control group, in the transition from the second to the third trimester of pregnancy, when there is a physiologic increase in arterial pressure. The systolic pressure check will be in outpatient consultation with intervals of 15 days, during. The device used for checking the pressure will be the GAMMA XXL LF of Heine General Medicine. All blood pressure checks either in the intervention group or control group will be performed on the same device.
4 secondary outcomes
Assessment of quality of life with World Health Organization instrument for evaluating quality of life (Whoqol-bref) questionnaire.
Time frame: 8 weeks
Assessment of anxiety and depression with The Hospital Anxiety and Depression Scale (HADS).
Time frame: 8 weeks
Assessment of the capacity to adapt and restore equilibrium to their lives and avoid the potentially deleterious effects of stress with Resilience Scale.
Time frame: 8 weeks
Assessment on the presence or absence of attention to and awareness of what is occurring in the present, that differentiates meditation practitioners from others, with Mindful Attention Awareness Scale (MAAS)
Time frame: 8 weeks
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 24 Mar 2022.
- Background: PubMed 23091073Gow AJ, Bastin ME, Munoz Maniega S, Valdes Hernandez MC, Morris Z, Murray C, Royle NA, Starr JM, Deary IJ, Wardlaw JM. Neuroprotective lifestyles and the aging brain: activity, atrophy, and white matter integrity. Neurology. 2012 Oct 23;79(17):1802-8. doi: 10.1212/WNL.0b013e3182703fd2.
- Background: PubMed 20332328Himelstein S. Meditation research: the state of the art in correctional settings. Int J Offender Ther Comp Criminol. 2011 Jun;55(4):646-61. doi: 10.1177/0306624X10364485. Epub 2010 Mar 23.
- Background: PubMed 28709727Bernstein PS, Martin JN Jr, Barton JR, Shields LE, Druzin ML, Scavone BM, Frost J, Morton CH, Ruhl C, Slager J, Tsigas EZ, Jaffer S, Menard MK. Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period. J Obstet Gynecol Neonatal Nurs. 2017 Sep-Oct;46(5):776-787. doi: 10.1016/j.jogn.2017.05.003. Epub 2017 Jul 11.
- Background: PubMed 28661961Fitton CA, Steiner MFC, Aucott L, Pell JP, Mackay DF, Fleming M, McLay JS. In-utero exposure to antihypertensive medication and neonatal and child health outcomes: a systematic review. J Hypertens. 2017 Nov;35(11):2123-2137. doi: 10.1097/HJH.0000000000001456.
- Background: PubMed 17764203Ospina MB, Bond K, Karkhaneh M, Tjosvold L, Vandermeer B, Liang Y, Bialy L, Hooton N, Buscemi N, Dryden DM, Klassen TP. Meditation practices for health: state of the research. Evid Rep Technol Assess (Full Rep). 2007 Jun;(155):1-263.
- Background: PubMed 18588603Kozasa EH, Radvany J, Barreiros MA, Leite JR, Amaro E Jr. Preliminary functional magnetic resonance imaging Stroop task results before and after a Zen meditation retreat. Psychiatry Clin Neurosci. 2008 Jun;62(3):366. doi: 10.1111/j.1440-1819.2008.01809.x. No abstract available.
- Background: PubMed 28222185Stahl JE, Dossett ML, LaJoie AS, Denninger JW, Mehta DH, Goldman R, Fricchione GL, Benson H. Correction: Relaxation Response and Resiliency Training and Its Effect on Healthcare Resource Utilization. PLoS One. 2017 Feb 21;12(2):e0172874. doi: 10.1371/journal.pone.0172874. eCollection 2017.
- Background: PubMed 12441200Mulder EJ, Robles de Medina PG, Huizink AC, Van den Bergh BR, Buitelaar JK, Visser GH. Prenatal maternal stress: effects on pregnancy and the (unborn) child. Early Hum Dev. 2002 Dec;70(1-2):3-14. doi: 10.1016/s0378-3782(02)00075-0.
- Background: PubMed 18317710Vieten C, Astin J. Effects of a mindfulness-based intervention during pregnancy on prenatal stress and mood: results of a pilot study. Arch Womens Ment Health. 2008;11(1):67-74. doi: 10.1007/s00737-008-0214-3. Epub 2008 Mar 3.
- Background: PubMed 18336440Beddoe AE, Lee KA. Mind-body interventions during pregnancy. J Obstet Gynecol Neonatal Nurs. 2008 Mar-Apr;37(2):165-75. doi: 10.1111/j.1552-6909.2008.00218.x.
- Background: PubMed 19538619Beddoe AE, Paul Yang CP, Kennedy HP, Weiss SJ, Lee KA. The effects of mindfulness-based yoga during pregnancy on maternal psychological and physical distress. J Obstet Gynecol Neonatal Nurs. 2009 May-Jun;38(3):310-9. doi: 10.1111/j.1552-6909.2009.01023.x.
- Background: PubMed 24925904van den Heuvel MI, Donkers FC, Winkler I, Otte RA, Van den Bergh BR. Maternal mindfulness and anxiety during pregnancy affect infants' neural responses to sounds. Soc Cogn Affect Neurosci. 2015 Mar;10(3):453-60. doi: 10.1093/scan/nsu075. Epub 2014 Jun 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation and conventional treatment in people with Hypertension, Pregnancy-Induced and Hypertension in Pregnancy, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 8 inclusion and 3 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 24 Mar 2022. 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 Brazil. 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?
Comparison the means of diastolic blood pressure of pregnant women's between intervention group and control group. (time frame: 8 weeks). The study lists 2 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 NCT03873194, which also lists 21 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 24 Mar 2022.