Prenatal Yoga as Complementary Therapy of Preeclampsia

NCT ID: NCT04795154

Last Updated: 2021-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-02

Study Completion Date

2020-12-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pre-Eclampsia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pre-test group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Yoga excercise

Intervention Type OTHER

Yoga exercise in pre-eclampsia \>20 weeks of pregnancy woman, treatment number was 4 times.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Yoga excercise

Yoga exercise in pre-eclampsia \>20 weeks of pregnancy woman, treatment number was 4 times.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Ocktariyana, SST, M.Kes

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Murdiningsih Murdiningsih

Role: PRINCIPAL_INVESTIGATOR

Politeknik Kesehatan Palembang

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Poltekkes Palembang Kemenkes RI

Palembang, South of Sumatera, Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 22399208 (View on PubMed)

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.

Reference Type RESULT
PMID: 22884667 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://pubmed.ncbi.nlm.nih.gov/22399208/

https://pubmed.ncbi.nlm.nih.gov/22399208/

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OCK1982

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.