Prenatal Yoga as Complementary Therapy of Preeclampsia

NCT04795154 | Completed

• 1 other identifier: OCK1982
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia

Keywords

Pre-eclampsia; Yoga; Pregnancy; exercise; complementary

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

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).

Other: Yoga excercise

Interventions

Yoga excercise OTHER

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

Post-test group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnancy woman with gestational age at least 20 weeks and occurred pre-eclampsia.
• Approved as a participant with sign in an informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Poltekkes Palembang Kemenkes RI

Palembang, South of Sumatera, 30163, Indonesia

Location

Related 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.

  PMID: 22399208 RESULT

• 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.

  PMID: 22884667 RESULT

Related Links

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

MeSH Terms

Conditions

Pre-Eclampsia; Motor Activity

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Study Officials

• Murdiningsih Murdiningsih

  Politeknik Kesehatan Palembang

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: March 12, 2021
• Study Start: September 2, 2020
• Primary Completion: October 28, 2020
• Study Completion: December 22, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)