NCT04226183

Brief Summary

Pregnancy is a condition that increased requirements of energy and oxygen, and if this condition is not maximally that can lead oxidative stress and produce free radicals which is affect in the pregnancy process. Malondialdehyde (MDA) level in pregnant women is higher than non-pregnant women. Exercise is one way to neutralize the free radical. The aim of this study was analyzed effect of treatment natural antioxidants after exercise which was pregnancy workout to MDA level in the third trimester of pregnancy. This study was a true experimental study. There were 24 prenatal pregnant women and separated to 3 groups, which were 8 prenatal pregnant women without pregnancy workout as a control group, 8 prenatal pregnant women with pregnancy workout but without natural antioxidant consume as a positive control group, and 8 prenatal pregnant women with natural antioxidant consume after pregnancy workout as a treatment group. The antioxidant compounds given in this study were guava juice that contains vitamin C. MDA levels was analyzed by spectrophotometric. Comparison between groups was done by one way ANOVA test.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2016

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

January 9, 2020

Last Update Submit

January 14, 2020

Conditions

Keywords

AntioxidantsMalondialdehyde levelthe third trimester of pregnancyexerciseanti oxidantstress oxidative

Outcome Measures

Primary Outcomes (1)

  • MDA level

    Malondialdehyde (MDA) levels is stress oxidative marker. MDA level messured with spectrophotometric assay. at Bio Sains Riset Laboratory, Palembang. Firstly, Mix 0.5ml blank + 0.5 ml standard and 0.5 ml serum using vortex mixer. Centrifuge for 10 minutes, with a speed of 2000 rpm, and Pipette 1 ml each filtrate and after that put it in boiling water bath for 30 minutes, then chill and read the absorbance with a spectrophotometer with a wavelength of 550 nm.

    7 days.

Study Arms (3)

control group

NO INTERVENTION

pregnant women without pregnancy workout and consume guava juice

positive control group

EXPERIMENTAL

prenatal pregnant women with pregnancy workout but not consume guava juice

Other: pregnancy workout

treatment group

EXPERIMENTAL

prenatal pregnant women with pregnancy workout and consume guava juice

Other: pregnancy workout

Interventions

Procedure of pregnancy workout has been legalized by the Ministry of Health of Indonesia act 2014 No.97. 100 ml fresh guava juice without sugar

Also known as: fresh Guava juice
positive control grouptreatment group

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Approve as a subject of review and sign in an informed consent
  • Approve to take 3 ml of whole blood.
  • Ages 20-30 years
  • Hemoglobin levels higher than 11 gr%
  • Third trimester of pregnancy
  • Healthy condition during reseach

You may not qualify if:

  • Anemia
  • Pathologies condition during pregnant
  • Allergic
  • Disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Nazari A, Dirandeh E, Ansari-Pirsaraei Z, Deldar H. Antioxidant levels, copper and zinc concentrations were associated with postpartum luteal activity, pregnancy loss and pregnancy status in Holstein dairy cows. Theriogenology. 2019 Jul 15;133:97-103. doi: 10.1016/j.theriogenology.2019.04.034. Epub 2019 Apr 30.

  • Patil SB, Kodliwadmath MV, Kodliwadmath SM. Correlation between lipid peroxidation and non-enzymatic antioxidants in pregnancy induced hypertension. Indian J Clin Biochem. 2008 Jan;23(1):45-8. doi: 10.1007/s12291-008-0011-9. Epub 2008 Mar 6.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ocktariyana Ocktariyana

    Ministry of health, Health Polytechnic, Palembang

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
care provider is a midwifery as a intructure of excercise and measure of each pregnant participans condition. investigator is controling all reseach procedure.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There were 24 prenatal pregnant women and separated to 3 groups, which were 8 prenatal pregnant women without exercise as a control group, 8 prenatal pregnant women with exercise as a positive control group and 8 prenatal pregnant women with exercise and consume natural antioxidants after exercise as a treatment group. The antioxidant compounds given in this study were guava juice that contains vitamin C.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 13, 2020

Study Start

February 3, 2016

Primary Completion

August 26, 2016

Study Completion

October 17, 2016

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share