Comparison of the effect of nipple stimulation with acupressure spatial point 6 in prevention of postpartum pregnancy
Design
The clinical trial has three groups (control, intervention number 1 and 2), randomized
Settings and conduct
This study was started at Martyrdom Moghini Sabzevar Hospital in randomly assigned samples at 39 weeks of gestational age.
Participants/Inclusion and exclusion criteria
Entry criteria: having a gestational age of 39 to 40 weeks, having a maximum of one delivery, not having a history of cesarean section.
Exit criteria: Withdrawal of cooperation, the use of traditional or chemical drugs for induction of labor
Intervention groups
The intervention group 1 is recommended to do 3 times every 10 minutes each day until the onset of uterine contractions is triggered by hand. Stimulate each breasts frequently and around the nipple. In the intervention group, 2 people should be pressurized 3 times a day for 1 minute on one leg and then apply pressure on the opposite leg for about 20-30 minutes. The control group receives routine care.
Main outcome variables
Preterm pregnancy prevention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151005024371N2
Registration date:2019-01-06, 1397/10/16
Registration timing:retrospective
Last update:2019-01-06, 1397/10/16
Update count:0
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Mozhdeh Navi Nezhad
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4423 3808
Email address
navinm921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Nipple Stimulation with Acupressure Point 6 Spleen in the Prevention of Early Pregnancy in Primiparous Women
Public title
Comparison of the Effect of Nipple Stimulation with Acupressure Point 6 Spleen in the Prevention of Early Pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a gestational age of 39 to 40 weeks
Having a maximum of one delivery
Singleton pregnancy and Cephalic display
Having a low grade score of 4 at the beginning of the study
Not having fetal abnormalities in ultrasounds during pregnancy
Natural amniotic fluid in ultrasound
Not having cesarean history
Lack of fast delivery
Women with 18to 35 years old
Exclusion criteria:
Disclaimer of cooperation
Use of traditional or chemical drugs to induce labor
Failure to perform recommended interventions completely over 1 day
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
177
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were randomly assigned to randomly blocks (Block Randomization) into three groups of 59, called control groups (routine care center), intervention 1 (nipple stimulation) and intervention 2 (spinal cord pressure) Get it.
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
Sabzevar University Of Medical Sciences
Street address
Kashfi Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613883778
Approval date
2018-09-17, 1397/06/26
Ethics committee reference number
IR.MEDSAB.REC. 1397.033
Health conditions studied
1
Description of health condition studied
Prolonged pregnancy
ICD-10 code
O47.9
ICD-10 code description
False labour, unspecified
Primary outcomes
1
Description
Percentage of people who have an early pregnancy
Timepoint
From 39 to 41 weeks pregnant
Method of measurement
With a vaginal examination to examine the opening and softness of the cervix
Secondary outcomes
1
Description
Progress of labour
Timepoint
In active phase per 1 hour
Method of measurement
Partograph
Intervention groups
1
Description
Control group: The observation of 59 mothers from the 39th week of gestation based on the first day of the last menstrual period or the first three months of the first sonoon and the daily control of the fetal heart sounds until the onset of labor pain and admission to the maternity ward for delivery
Category
Prevention
2
Description
Intervention group 1: 59 women who are recommended from 39 weeks of gestation are recommended 3 times daily for 10 minutes until the onset of uterine contractions. Stimulate each breasts frequently and around the nipple.
Category
Prevention
3
Description
Intervention group 2: Apply 3 times daily for 1 minute on one leg and then apply pressure on the opposite leg for about 30 to 20 minutes later.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mobini hospital
Full name of responsible person
Mitra Eftekhar Yazdi
Street address
Kashfi Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613883778
Phone
+98 51 4423 8100
Email
navinm921@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Street address
Asad abadi Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613883778
Phone
+98 51 4423 8100
Email
drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mozhdeh Navi Nezhad
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Kashfi Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613883778
Phone
+98 51 4423 8100
Email
navinm921@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mozhdeh Navi Nezhad
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Kashfi Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613883778
Phone
+98 51 4423 8100
Email
navinm921@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mozhdeh Navi Nezhad
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Kashfi Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613883778
Phone
+98 51 4423 8100
Email
navinm921@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All participants' data will be available to applicants
When the data will become available and for how long
Within 6 months after the publication of the article
To whom data/document is available
Professors and academic researchers
Under which criteria data/document could be used
Doing an analysis on delivered data is not allowed
From where data/document is obtainable
The author is responsible and by request via email
What processes are involved for a request to access data/document
After requesting by email, within 10 days, the requested information will be provided to the applicant