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Prenatal Yoga as Complementary Therapy of Preeclampsia

Primary Purpose

Pre-Eclampsia

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Yoga excercise
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-Eclampsia focused on measuring Pre-eclampsia, Yoga, Pregnancy, exercise, complementary

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Poltekkes Palembang Kemenkes RI

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pre-test group

Post-test group

Arm Description

pregnant women> 20 weeks who had blood pressure level which was 130/80 mmHg to 140/90 mmHg without treatment.

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).

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2021
Last Updated
March 10, 2021
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT04795154
Brief Title
Prenatal Yoga as Complementary Therapy of Preeclampsia
Official Title
Prenatal Yoga Implementation As Complementary Therapy Of Preeclampsia Of Pregnant Woman At Puskesmas And Mandiri Practice Midwives In Palembang City
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
October 28, 2020 (Actual)
Study Completion Date
December 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia
Keywords
Pre-eclampsia, Yoga, Pregnancy, exercise, complementary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
The participant was pregnant women> 20 weeks who had blood pressure level which was 130/80 mmHg to 140/90 mmHg, who was approved as the subject of research and sign in the informed consent. The care provider was a midwife who was competent in yoga exercise, pregnancy care services, as well as competent phlebotomies. Investigator was the authors in this research.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-test group
Arm Type
No Intervention
Arm Description
pregnant women> 20 weeks who had blood pressure level which was 130/80 mmHg to 140/90 mmHg without treatment.
Arm Title
Post-test group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Yoga excercise
Intervention Description
Yoga exercise in pre-eclampsia >20 weeks of pregnancy woman, treatment number was 4 times.
Primary Outcome Measure Information:
Title
Blood pressure
Description
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.
Time Frame
The blood pressure measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
Title
Protein urine level
Description
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.
Time Frame
the protein urine level measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
Title
blood platelets level
Description
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.
Time Frame
blood platelets level measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murdiningsih Murdiningsih
Organizational Affiliation
Politeknik Kesehatan Palembang
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poltekkes Palembang Kemenkes RI
City
Palembang
State/Province
South Of Sumatera
ZIP/Postal Code
30163
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22399208
Citation
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.
Results Reference
result
PubMed Identifier
22884667
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/22399208/
Description
https://pubmed.ncbi.nlm.nih.gov/22399208/

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Prenatal Yoga as Complementary Therapy of Preeclampsia

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