- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04795154
Prenatal Yoga as Complementary Therapy of Preeclampsia
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.
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Of Sumatera
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Palembang, South Of Sumatera, Indonesia, 30163
- Poltekkes Palembang Kemenkes RI
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnancy woman with gestational age at least 20 weeks and occurred pre-eclampsia.
- Approved as a participant with sign in an informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Pre-test group
pregnant women> 20 weeks who had blood pressure level which was 130/80 mmHg to 140/90 mmHg without treatment.
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Experimental: Post-test group
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).
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Yoga exercise in pre-eclampsia >20 weeks of pregnancy woman, treatment number was 4 times.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood pressure
Time Frame: The blood pressure measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
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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. |
The blood pressure measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
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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.
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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.
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the protein urine level measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
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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.
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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. |
blood platelets level measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Murdiningsih Murdiningsih, Politeknik Kesehatan Palembang
Publications and helpful links
General 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.
- Rakhshani 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCK1982
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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