Prenatal Yoga as Complementary Therapy of Preeclampsia

Pre-Eclampsia Clinical Trial

Official title:

Prenatal Yoga Implementation As Complementary Therapy Of Preeclampsia Of Pregnant Woman At Puskesmas And Mandiri Practice Midwives In Palembang City

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795154
• Other study ID #: OCK1982
• Status: Completed
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: December 22, 2020

Study information

• Verified date: March 2021
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 22, 2020
• Est. primary completion date: October 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Other:
• Yoga excercise
Yoga exercise in pre-eclampsia >20 weeks of pregnancy woman, treatment number was 4 times.

Locations

Country	Name	City	State
Indonesia	Poltekkes Palembang Kemenkes RI	Palembang	South Of Sumatera

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

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. Review. — View 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.2012.07.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The blood pressure measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
Primary	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.	the protein urine level measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.
Primary	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.	blood platelets level measured two times measurement that were 1 hour before yoga exercise and 1 hour after yoga exercise.

External Links

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