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Evaluation of the effectiveness of progressive muscle relaxation on maternal and neonatal outcomes on primiparous women with preeclampsia in Kamali hospital,Karaj, Iran 2019-2020

Protocol summary

Study aim
Evaluation of the effectiveness of progressive muscle relaxation on maternal and neonatal outcomes on primary parous women with preeclampsia
Design
This study is a randomized clinical trial with two parallel control and intervention groups. Participants (88 eligible women with inclusion criteria) will be entered the study through convenient sampling. Allocation will be done using block randomization.
Settings and conduct
Pre-natal and Emergency wards of Kamali hospital in Karaj
Participants/Inclusion and exclusion criteria
inclusion criteria:1-primiparous women with 26-34 weeks gestational age 2-singleton pregnancy 3-non-severe preeclampsia 4-low risk results in the first and second trimesters fetal screenings 5-persian race and at least having reading and writing literacy. Exclusion criteria:1-physical and mental illnesses (such as cardio-respiratory disease, diabetes mellitus and gestational diabetes, seizure, depression, anxiety disorders ,etc) 2- history of infertility and/or repeated miscarriage 3- vaginal hemorrhage and/or leaking amniotic fluid and/or uterine contractions 4- recent severe stress and/or anxiety 5- intrauterine growth restriction 6- usage of alcohol and/or cigarettes and/or drugs
Intervention groups
In the intervention group, in addition to routine prenatal care, progressive muscle relaxation will be performed and the control group will receive only routine prenatal care
Main outcome variables
blood pressure, proteinuria, fasting blood sugar, maternal weight gain, ammonium fluid index, gestational age at delivery, becoming severe preeclampsia, fetal movements, and fetal heart rate, l APGAR score, and neonatal anthropometric indices

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180110038302N6
Registration date: 2020-06-27, 1399/04/07
Registration timing: registered_while_recruiting

Last update: 2020-06-27, 1399/04/07
Update count: 0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Mansoureh Yazdkhasti
Name of organization / entity
Alborz University medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 8856
Email address
m.yazdkhasti@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-19, 1398/12/29
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of progressive muscle relaxation on maternal and neonatal outcomes on primiparous women with preeclampsia in Kamali hospital,Karaj, Iran 2019-2020
Public title
Evaluation of the effectiveness of progressive muscle relaxation on maternal and neonatal outcomes on primary parous women with preeclampsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
primary parous women with 26-34 weeks gestational age singleton pregnancy non-severe preeclampsia criterias low risk results in the frist and second trimester fetal screenings persiane race and at least having reading and writing literacy
Exclusion criteria:
physical and mental illnesses (such as cardio-respiratory disease, diabetes mellitus and gestational diabetes, seizure, depression, anxiety disorders ,etc) history of infertility and/or repeated miscarriage vaginal hemorrhage and/or leaking amniotic fluid and/or uterine contractions recent severe stress and/or anxiety intrauterine growth restriction usage of alcohol and/or cigarettes and/or drugs
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Block Balance Randomization 4th is accomplished with software. In this method size of the whole Blocks are equal. In this study with 88 sample sizes, blocks are 22 th and the size of each block is 4 th .The number of participants in the control and intervention group is equal(44 in each group).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
West Buali street, Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
sara_ghorbannejad25@
Approval date
2020-05-01, 1399/02/12
Ethics committee reference number
IR.ABZUMS.REC.1399.033

Health conditions studied

1

Description of health condition studied
Preeclampsia
ICD-10 code
O15.00
ICD-10 code description
Eclampsia in pregnancy, unspecified trimester

Primary outcomes

1

Description
Blood pressure
Timepoint
before and after 6 weeks of intervention
Method of measurement
mercury sphygmo manometer

Secondary outcomes

1

Description
proteinuria
Timepoint
before and after 6 weeks of intervention
Method of measurement
collect a 24-hr clean midstream urine sample

2

Description
fasting blood sugar
Timepoint
before and after 6 weeks of intervention
Method of measurement
glucometer

3

Description
maternal weight gaining
Timepoint
before and after 6 weeks of intervention
Method of measurement
digital scale

4

Description
turn to severe preeclampsia
Timepoint
after 6 weeks of intervention
Method of measurement
collect a 24-hr clean midstream urine sample and mercury sphygmo manometer

5

Description
delivery gestational age
Timepoint
after 6 weeks of intervention
Method of measurement
hospital document

6

Description
amniotic fluid index
Timepoint
before and after 6 weeks of intervention
Method of measurement
ultra sonogram

7

Description
fetal movement
Timepoint
before and after 6 weeks of intervention
Method of measurement
none stress test

8

Description
fetal heart rate
Timepoint
before and after 6 weeks of intervention
Method of measurement
none stress test

9

Description
apgar score
Timepoint
after 6 weeks of intervention
Method of measurement
hospital document

10

Description
antropometric index
Timepoint
after 6 weeks of intervention
Method of measurement
hospital document

Intervention groups

1

Description
Intervention group: using progressive muscle relaxation, which is done for 12 sessions by 6 weeks and 2 sessions per week
Category
Other

2

Description
Control group:beside routine prenatal care,No action will be taken for the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Mansooreh Yazdkhusti
Street address
West Buali street, Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7483
Email
Mansoyazd@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Mansooreh Yazdkhusti
Street address
West Buali street, Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7483
Email
sara_ghorbannejad25@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Alborz medical science university
Full name of responsible person
Mansooreh Yazdkhusti
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
West Buali street, Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7483
Email
Mansoyazd@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Mansooreh Yazdkhusti
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
West Buali street, Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7483
Email
Mansoyazd@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Sara Ghorbannejad
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
West Buali street, Alborz University of Medical Sciences
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7483
Email
sara_ghorbannejad25@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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