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The Effect of Acupressure on Initiation of labor In Post term Pregnancy

Protocol summary

Summary
This randomized controlled clinical trial was carried out at the Ganjavian Hospital in Dezful, Iran. Eighty eligible nulliparous women were randomized to acupressure group versus usual medical care (control group). For Women in intervention group, acupressure was done in Large Intestine.4 (Hego), Spleen.6 (Sanynjiao), Gall bladder.21 (Jianjing) with special technique under supervision of acupuncturist in 60 seconds pressure, 30 seconds rest and this procedure was repeated 5 times in each point, that takes 30 minutes. In control group usual medical care was done. If delivery wasn’t done, 24 hours after first session, acupressure was repeated and if labor spontaneously didn’t initiate until end of 41 weeks, Labor induced with classic induction. Patients in both group was evaluated for: Bishop score variations, number of people had spontaneous labor, period from acupressure to delivery, period from acc to active phase, period from Estimate Date of Confinement until Actual date of delivery, mode of delivery, need of oxytocin.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109257631N1
Registration date: 2012-05-27, 1391/03/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-05-27, 1391/03/07
Registrant information
Name
Zeinb Talebzadeh
Name of organization / entity
Ahvaz Jundishapur university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 64 1222 2395
Email address
talebzadeh-zr@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Ahwaz University of Medical Sciences
Expected recruitment start date
2010-07-06, 1389/04/15
Expected recruitment end date
2010-11-11, 1389/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acupressure on Initiation of labor In Post term Pregnancy
Public title
The Effect of Acupressure on Initiation of labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: nulliparous women with uncomplicated pregnancy; Cephalic singleton fetus at 40 – 42 weeks of gestation and Bishop score≤ 4; Normal Biophysical profile and NST. Exclusion Criteria: Obvious tight pelvic in vaginal exam; using other methods of labor induction like caster oil, nipple stimulation; being in active phase or having contraction; preeclampsia; Diabetes or other systemic disease.
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: 80
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
Vice Chancellor For Research of Ahwaz University of Medical Sciences
Street address
Vice Chancellor for Research and Information Technology, University of Medical Sciences, Ahwaz Jondishapour, Ground Floor, University city
City
Ahwaz
Postal code
6135715794
Approval date
2010-10-16, 1389/07/24
Ethics committee reference number
ETH046

Health conditions studied

1

Description of health condition studied
postdate pregnancy
ICD-10 code
O48
ICD-10 code description
Prolonged pregnancy

Primary outcomes

1

Description
bishop score
Timepoint
first session for acupressure, 24 hours after first time and until delivery
Method of measurement
Vaginal exam

2

Description
Spontaneous delivery
Timepoint
first session for acupressure, 24 hours after first time and until delivery
Method of measurement
Vaginal exam

3

Description
period of time from acupressure to delivery and active phase
Timepoint
first session for acupressure, 24 hours after first time and until delivery
Method of measurement
time

Secondary outcomes

empty

Intervention groups

1

Description
acupressure was done 30 minutes in 3 points include LI.4, GB.21 and SP.6
Category
Other

2

Description
control group didn't have any intervention and did midwifery routine .
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dezful Ganjavian Hospital
Full name of responsible person
Zeinab Talebzadeh
Street address
Dezful Ganjavian Hospital, Opposit of Zamini padegan, Dezful-Andimeshk Road
City
Dezful

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahwaz University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Jondi Shapur Ahwaz University of Medical Sciences, opposite the central building
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Ahwaz 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Zeinab.Talebzadeh
Position
Graduate Student
Other areas of specialty/work
Street address
Jondi Shapur Ahwaz University of Medical Sciences, School of Nursing and Midwifery
City
Ahvaz
Postal code
Phone
+98 64 1222 2395
Fax
Email
talebzadeh-zr@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Mitra Tadayon
Position
Master Science
Other areas of specialty/work
Street address
Jondi Shapur Ahwaz University of Medical Sciences, School of Nursing and Midwifery
City
Ahwaz
Postal code
Phone
+98 61 1373 8394
Fax
+98 61 1373 8394
Email
tadayon-mw@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Science
Full name of responsible person
Zeinab Talebzadeh
Position
Graduate Student
Other areas of specialty/work
Street address
City
Ahwaz
Postal code
Phone
+98 64 1222 2395
Fax
+98 64 1222 2395
Email
Talebzadeh-zr@ajums.ac.ir zeinab.talebzadeh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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