The cervical ripening is one of the main stage in start of delivery and it,s necessary for successful labour.
This study was done with theaim of determining the effect of acupressure on cervical ripening, initiation and outcome of labour.
In this randomized clinical trial, 150 primigravida with term pregnancy referring to Deziani hospital in Gorgan were chosen and they were put in three group.
1. Acupressure which was done by researcher
2. By mother
3 . Control group(routine care)
In two case groups(1 , 2) daily pressure on six splenic or sanynjyayv
for 20 minutes about 5 days was done.
About 48 before intervention, 96 hours after that and at the time of hospitalization the elements were checked from cervical ripening and initiation of labour point of view.
The tools for gathering information were demographic characteristics and midwifery history questionnaire, daily record and follow up forms. Content validity is used for validity of tools. Reliability of observation check list and physical examination was confirmed by interrater(inter observer) and test-re-test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204239542N1
Registration date:2012-08-09, 1391/05/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-09, 1391/05/19
Registrant information
Name
Khadijeh Ghobadi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 212401022
Email address
kadijehg@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-06-19, 1390/03/29
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of acupressure's effect on cervical ripening, initiation and outcome of labor in term nulliparous women
Public title
Effect of acupressure on labor onset
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
18-35 years old
Primigravida
Singleton pregnancy
Cephalic presentation
Gestational age from 39 to 41 weeks
Bishop Score≤ 4
Low risk pregnancy
Not taking herbal or chemical drugs, 36 hours before and up to end of the study.
Not having sexual intercourse 24 hours before and up to end of the study.
Exclusion criteria:
The following lead to excluding the elements during study:
1-Taking chemical or herbal drugs.
2-Having sexual intercourse
3-High risk pregnancy
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:
150
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahid Beheshti University of Medical Sciences
Street address
Next to Taleghani hospital, Evin, Shahid Chamran Highway,Tehran, Iran
City
Tehran
Postal code
Approval date
2011-06-12, 1390/03/22
Ethics committee reference number
400/2157
2
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Next to Taleghani hospital, Evin, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
400/2157
Health conditions studied
1
Description of health condition studied
cervical ripening and initiation of labor
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
Cervical ripening
Timepoint
Before intervention,48 and 96 hours after intervation and at the time of hospitalization
Method of measurement
Examination
2
Description
Onset of labor
Timepoint
Before intervention,48 and 96 hours after intervation and at the time of hospitalization
Method of measurement
Examination
Secondary outcomes
1
Description
Type of delivery
Timepoint
at last of study
Method of measurement
Hospital document
2
Description
Using of oxytocin
Timepoint
at last of study
Method of measurement
Hospital document
3
Description
first stage of labor
Timepoint
at last of study
Method of measurement
hospital documents
4
Description
second stage of labor
Timepoint
at last of study
Method of measurement
hospital documents
5
Description
Neonatal Apgar
Timepoint
at last of study
Method of measurement
hospital documents
Intervention groups
1
Description
1. Accupressure which was done by researcher
2. By mother
In two case groups (1,2) daily pressure on six splenic for 20 minutes about 5 days was done.
Category
Prevention
2
Description
Control group: routine care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Deziani Educational Center
Full name of responsible person
Khadijeh Ghobadi
Street address
Deziani Educational Center, Gorgan, Golestan, Iran
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Simbar
Street address
Deputy of Research, School of Nursing and Midwifery
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khadijeh Ghobadi
Position
Master of Midwifery
Other areas of specialty/work
Street address
Shahid Beheshti Faculty of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 17 1337 5322
Fax
Email
kadijehg@yahoo.com
raha.1674@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khadijeh Ghobadi
Position
Master of Midwifery
Other areas of specialty/work
Street address
Deziani Educational Center, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1337 5322
Fax
Email
kadijehg@yahoo.com raha.1674@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khadijeh Ghobadi
Position
Master of Midwifery
Other areas of specialty/work
Street address
Deziani Educational Center, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1222 4859
Fax
Email
kadijehg@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)