Pre-EclampsiaNCT04795154
Prenatal Yoga as Complementary Therapy of Preeclampsia
A study testing Yoga excercise in people with Pre-Eclampsia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Preeclampsia is a specific pregnancy disorder that complicates approximately 3-5% of all pregnancies. The effects on pregnant women vary from mild hypertension, severe hypertension / hypertensive crisis, eclampsia to hemolysis syndrome, elevated liver enzymes, low platelet count (HELLP), while the impact of these… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Yoga excercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Sep 2020to 22 Dec 2020
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnancy woman with gestational age at least 20 weeks and occurred pre-eclampsia.
- Approved as a participant with sign in an informed consent
Who cannot join
- diabetes mellitus
- kidney disorders
- heart defects
- chronic hypertension
- premature rupture of membranes
- clinical signs of infection
- Multiple pregnancies
- Death of the fetus in the womb
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Poltekkes Palembang Kemenkes RI
Palembang, South of Sumatera, 30163
About this study
Official title: Prenatal Yoga Implementation As Complementary Therapy Of Preeclampsia Of Pregnant Woman At Puskesmas And Mandiri Practice Midwives In Palembang City
Preeclampsia is a specific pregnancy disorder that complicates approximately 3-5% of all pregnancies. The effects on pregnant women vary from mild hypertension, severe hypertension / hypertensive crisis, eclampsia to hemolysis syndrome, elevated liver enzymes, low platelet count (HELLP), while the impact of these abnormalities on the fetus also varies from preterm birth, stunted fetal growth (CHD) to fetal death.
The initial cause of preeclampsia is still unknown, recent developments explain the molecular mechanisms behind its manifestations and especially abnormal development, placental hypoxia, endothelial dysfunction.
Read more
Prenatal yoga (yoga for pregnancy) is a modification of classical yoga which has been adapted to the physical condition of pregnant women which is done with a more gentle and slow intensity. Rakhsani A, et al., (2012) suggested that the positive effects of yoga for pregnant women are reducing occure of hypertension, preeclampsia, gestational diabetes as well as cases of intrauterine growth restriction (IUGR).
The purpose of this study was to determine the effect of prenatal yoga on reducing preeclampsia. This study was an experimental study that used pre and post-test mechanisms (paired test) with Yoga exercise treatment.
Read the detailed description
Preeclampsia is a specific pregnancy disorder that complicates approximately 3-5% of all pregnancies. The effects on pregnant women vary from mild hypertension, severe hypertension / hypertensive crisis, eclampsia to hemolysis syndrome, elevated liver enzymes, low platelet count (HELLP), while the impact of these abnormalities on the fetus also varies from preterm birth, stunted fetal growth (CHD) to fetal death.
The initial cause of preeclampsia is still unknown, recent developments explain the molecular mechanisms behind its manifestations and especially abnormal development, placental hypoxia, endothelial dysfunction.
Prenatal yoga (yoga for pregnancy) is a modification of classical yoga which has been adapted to the physical condition of pregnant women which is done with a more gentle and slow intensity. Rakhsani A, et al., (2012) suggested that the positive effects of yoga for pregnant women are reducing occure of hypertension, preeclampsia, gestational diabetes as well as cases of intrauterine growth restriction (IUGR).
The purpose of this study was to determine the effect of prenatal yoga on reducing preeclampsia. This study was an experimental study that used pre and post-test mechanisms (paired test) with Yoga exercise treatment.
The number of samples wares 24 samples from pregnant women> 20 weeks who had blood pressure level which was 130/80 mmHg to 140/90 mmHg. This study was carried out in September 2020. There were three parameters to measured decreased hypertension that is blood pressure, the protein level in urine, as well as blood platelets. The research was carried out in several public health centers where was Puskesmas Pembina and two clinics of midwives practice in Palembang city from September to November 2020. Yoga exercises technique used stretching and posture exercises (asanas) combined with deep breathing (pranayama) and meditation, to unify body, mind, and spirit (Babbar S, Parks-Savage AC, Chauhan SP, 2012).
- Conditions
- Pre-Eclampsia
- Being tested
- Yoga excercise
- Keywords
- Pre-eclampsia, Yoga, Pregnancy, exercise, complementary
- Medical subject headings
- Pre-Eclampsia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga excerciseOther
Yoga exercise in pre-eclampsia >20 weeks of pregnancy woman, treatment number was 4 times.
| Study group | Role | What they receive |
|---|---|---|
| Pre-test group | No intervention | pregnant women> 20 weeks who had blood pressure level which was 130/80 mmHg to 140/90 mmHg without treatment. |
| Post-test group | Experimental | pregnant women > 20 weeks who had blood pressure level which was 130/80 mmHg to 140/90 mmHg got yoga exercise, and post group was got yoga exercise was 30 minutes every 2 weeks for two months (4 times treatment). Yoga exercises technique used stretching and posture exercises (asanas) combined with deep breathing (pranayama) and meditation, to unify body, mind, and spirit (Babbar S, Parks-Savage AC, Chauhan SP, 2012). Receives: Other: Yoga excercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Blood pressure is the pressure of circulating blood against the walls of blood vessels to expressed the systolic pressure (maximum pressure during on heartbeat) over diastolic pressure (minimum pressure between two heartbeats) in the cardiac cycle.
. The blood pressure measure device used the digital sfigmomanometer.
Measured: The blood pressure measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
Protein urine level
The presence of proteins in urine (albumin urine) as an indication of problems in the kidneys which one is increased blood pressure. the normal value of urine albumin levels for random urine retrieval is 0-8 mg/dl. urine collected immediately after waking up which is before performing activities in the morning. about 50 ml volume of urine was measured used technique using high-performance liquid chromatography method to analysis the albumin urine.
Measured: the protein urine level measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
blood platelets level
Blood platelets or thrombocytes level test is count platelet level per microliter (mcL) of blood. TThe normal number of platelets in the blood is 150,000 to 400,000 platelets per microliter (mcL) or 150 to 400 × 109/L.
the blood collected from drawing blood from a vein in the arm or hand. Obtaining a sample of blood from a vein takes a few minutes and generally causes only minimal discomfort.
Measured: blood platelets level measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start2 Sep 2020
- Primary completion28 Oct 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Single group
- Model description
- This study was an experimental study that used pre and post-test designs in a single group. pre-group wasn't got yoga exercise, and post group was got yoga exercise was 30 minutes every 2 weeks for two months (4 times treatment). Yoga exercises technique used stretching and posture exercises (asanas) combined with deep breathing (pranayama) and meditation, to unify body, mind, and spirit (Babbar S, Parks-Savage AC, Chauhan SP, 2012). We obtained 24 samples from pregnant women\> 20 weeks who had blood pressure level which was 130/80 mmHg to 140/90 mmHg got fouth times yoga exercise during pregnancy. This study was carried out in September 2020. Every each subject was measured the hypertension level by systolic and diastolic blood pressure, the protein level in urine, as well as blood platelets. The research was carried out in several public health centers where was Puskesmas Pembina and two clinics of midwives practice in Palembang city from September to November 2020.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ocktariyana, SST, M.Kes, Universitas Indonesia
- Investigators
- Murdiningsih Murdiningsih, Principal investigator, Politeknik Kesehatan Palembang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795154
- Sponsor's protocol ID
- OCK1982
- Status last verified
- Mar 2021
- First submitted
- 10 Jan 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Babbar S, Parks-Savage AC, Chauhan SP. Yoga during pregnancy: a review. Am J Perinatol. 2012 Jun;29(6):459-64. doi: 10.1055/s-0032-1304828. Epub 2012 Mar 7.
PubMed 22399208Rakhshani A, Nagarathna R, Mhaskar R, Mhaskar A, Thomas A, Gunasheela S. The effects of yoga in prevention of pregnancy complications in high-risk pregnancies: a randomized controlled trial. Prev Med. 2012 Oct;55(4):333-340. doi: 10.1016/j.ypmed.2012.07.020. Epub 2012 Aug 2.
PubMed 22884667
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Yoga Implementation As Complementary Therapy Of Preeclampsia Of Pregnant Woman At Puskesmas And Mandiri Practice Midwives In Palembang City
- ClinicalTrials.gov ID
- NCT04795154
- Acronym / sponsor ID
- OCK1982
- Conditions
- Pre-Eclampsia
- Keywords
- Pre-eclampsia, Yoga, Pregnancy, exercise, complementary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 12 Mar 2021 (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.
Preeclampsia is a specific pregnancy disorder that complicates approximately 3-5% of all pregnancies. The effects on pregnant women vary from mild hypertension, severe hypertension / hypertensive crisis, eclampsia to hemolysis syndrome, elevated liver enzymes, low platelet count (HELLP), while the impact of these abnormalities on the fetus also varies from preterm birth, stunted fetal growth (CHD) to fetal death.
The initial cause of preeclampsia is still unknown, recent developments explain the molecular mechanisms behind its manifestations and especially abnormal development, placental hypoxia, endothelial dysfunction.
Prenatal yoga (yoga for pregnancy) is a modification of classical yoga which has been adapted to the physical condition of pregnant women which is done with a more gentle and slow intensity. Rakhsani A, et al., (2012) suggested that the positive effects of yoga for pregnant women are reducing occure of hypertension, preeclampsia, gestational diabetes as well as cases of intrauterine growth restriction (IUGR).
The purpose of this study was to determine the effect of prenatal yoga on reducing preeclampsia. This study was an experimental study that used pre and post-test mechanisms (paired test) with Yoga exercise treatment.
Detailed description
Preeclampsia is a specific pregnancy disorder that complicates approximately 3-5% of all pregnancies. The effects on pregnant women vary from mild hypertension, severe hypertension / hypertensive crisis, eclampsia to hemolysis syndrome, elevated liver enzymes, low platelet count (HELLP), while the impact of these abnormalities on the fetus also varies from preterm birth, stunted fetal growth (CHD) to fetal death.
The initial cause of preeclampsia is still unknown, recent developments explain the molecular mechanisms behind its manifestations and especially abnormal development, placental hypoxia, endothelial dysfunction.
Prenatal yoga (yoga for pregnancy) is a modification of classical yoga which has been adapted to the physical condition of pregnant women which is done with a more gentle and slow intensity. Rakhsani A, et al., (2012) suggested that the positive effects of yoga for pregnant women are reducing occure of hypertension, preeclampsia, gestational diabetes as well as cases of intrauterine growth restriction (IUGR).
The purpose of this study was to determine the effect of prenatal yoga on reducing preeclampsia. This study was an experimental study that used pre and post-test mechanisms (paired test) with Yoga exercise treatment.
The number of samples wares 24 samples from pregnant women> 20 weeks who had blood pressure level which was 130/80 mmHg to 140/90 mmHg. This study was carried out in September 2020. There were three parameters to measured decreased hypertension that is blood pressure, the protein level in urine, as well as blood platelets. The research was carried out in several public health centers where was Puskesmas Pembina and two clinics of midwives practice in Palembang city from September to November 2020. Yoga exercises technique used stretching and posture exercises (asanas) combined with deep breathing (pranayama) and meditation, to unify body, mind, and spirit (Babbar S, Parks-Savage AC, Chauhan SP, 2012).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study was an experimental study that used pre and post-test designs in a single group. pre-group wasn't got yoga exercise, and post group was got yoga exercise was 30 minutes every 2 weeks for two months (4 times treatment). Yoga exercises technique used stretching and posture exercises (asanas) combined with deep breathing (pranayama) and meditation, to unify body, mind, and spirit (Babbar S, Parks-Savage AC, Chauhan SP, 2012). We obtained 24 samples from pregnant women> 20 weeks who had blood pressure level which was 130/80 mmHg to 140/90 mmHg got fouth times yoga exercise during pregnancy. This study was carried out in September 2020. Every each subject was measured the hypertension level by systolic and diastolic blood pressure, the protein level in urine, as well as blood platelets. The research was carried out in several public health centers where was Puskesmas Pembina and two clinics of midwives practice in Palembang city from September to November 2020.
| Arm | Type | Receives |
|---|---|---|
| Pre-test group | No intervention | –pregnant women> 20 weeks who had blood pressure level which was 130/80 mmHg to 140/90 mmHg without treatment. |
| Post-test group | Experimental | Other: Yoga excercisepregnant women > 20 weeks who had blood pressure level which was 130/80 mmHg to 140/90 mmHg got yoga exercise, and post group was got yoga exercise was 30 minutes every 2 weeks for two months (4 times treatment). Yoga exercises technique used stretching and posture exercises (asanas) combined with deep breathing (pranayama) and meditation, to unify body, mind, and spirit (Babbar S, Parks-Savage AC, Chauhan SP, 2012). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnancy woman with gestational age at least 20 weeks and occurred pre-eclampsia.
- Approved as a participant with sign in an informed consent
Key exclusion criteria (8 listed)
- diabetes mellitus
- kidney disorders
- heart defects
- chronic hypertension
- premature rupture of membranes
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 |
|---|---|---|
| Yoga excerciseYoga exercise in pre-eclampsia >20 weeks of pregnancy woman, treatment number was 4 times. | Other | Post-test group |
Primary outcome
Blood pressure
Time frame: The blood pressure measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
Blood pressure is the pressure of circulating blood against the walls of blood vessels to expressed the systolic pressure (maximum pressure during on heartbeat) over diastolic pressure (minimum pressure between two heartbeats) in the cardiac cycle. . The blood pressure measure device used the digital sfigmomanometer.
Protein urine level
Time frame: the protein urine level measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
The presence of proteins in urine (albumin urine) as an indication of problems in the kidneys which one is increased blood pressure. the normal value of urine albumin levels for random urine retrieval is 0-8 mg/dl. urine collected immediately after waking up which is before performing activities in the morning. about 50 ml volume of urine was measured used technique using high-performance liquid chromatography method to analysis the albumin urine.
blood platelets level
Time frame: blood platelets level measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
Blood platelets or thrombocytes level test is count platelet level per microliter (mcL) of blood. TThe normal number of platelets in the blood is 150,000 to 400,000 platelets per microliter (mcL) or 150 to 400 × 109/L. the blood collected from drawing blood from a vein in the arm or hand. Obtaining a sample of blood from a vein takes a few minutes and generally causes only minimal discomfort.
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 12 Mar 2021.
- Results publication: PubMed 22399208Babbar S, Parks-Savage AC, Chauhan SP. Yoga during pregnancy: a review. Am J Perinatol. 2012 Jun;29(6):459-64. doi: 10.1055/s-0032-1304828. Epub 2012 Mar 7.
- Results publication: PubMed 22884667Rakhshani A, Nagarathna R, Mhaskar R, Mhaskar A, Thomas A, Gunasheela S. The effects of yoga in prevention of pregnancy complications in high-risk pregnancies: a randomized controlled trial. Prev Med. 2012 Oct;55(4):333-340. doi: 10.1016/j.ypmed.2012.07.020. Epub 2012 Aug 2.
- https://pubmed.ncbi.nlm.nih.gov/22399208/Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pre-Eclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Murdiningsih Murdiningsih principal investigator
Politeknik Kesehatan Palembang
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga excercise in people with Pre-Eclampsia, run by Universitas Indonesia at 1 site in Indonesia.
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 8 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 12 Mar 2021. 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 Indonesia. 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?
Blood pressure (time frame: The blood pressure measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.). 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 NCT04795154, which also lists 2 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 12 Mar 2021.