This study is designed to determine the effect of acupressure on cervical ripening, initiation and outcome of labor in postdate women. This study population comprised 150 pregnant women with referring to Shahid Akbar Abadi hospital in Tehran were included to 3 group acupressure, sham acupressure and control group. Inclusion criteria: gestational age of 39-41 weeks ؛ nulliparous women؛ bishop score< 4. Exclusion criteria: discontinuing of the study by mother request؛ taking chemical or herbal drugs. Acupressure was performed at the 3 acupoints, 6 spleen, 32 and 60 bladder for 30 minutes twice a day by the mother and the researcher. In the sham acupressure group, pressure was applied in ineffective point for 30 minutes 2 times a day. In this study, primary outcome variables are cervical ripening and initiation of labor.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042321904N1
Registration date:2015-12-19, 1394/09/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-19, 1394/09/28
Registrant information
Name
Fatemeh Mahmoudi Kohani
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 854 3127
Email address
f.mahmodi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-04-06, 1394/01/17
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupressure on cervical ripening, initiation and outcome of labor in postdate women
Public title
Effect of acupressure on initiation of labor
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of 18-35 years old؛ gestational age of 39-41 weeks based on LMP or ultrasound in first trimester؛ nulliparous women؛ single fetus with cephalic presentation؛ intact membrane؛ bishop score< 4؛ body mass index between 19/8 to 30؛ estimated fetal weight between ( 4000-2500 gr )؛ low risk pregnancy؛ not having sexual intercourse 24 hours before and up to end of the study؛ not use of any kind of chemical drug or herb to start labor for 36 hours before study
Exclusion criteria: discontinuing of the study by mother request؛ taking chemical or herbal drugs.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Science
Street address
Next to Taleghani hospital, Evin, Shahid Chamran Highway,Tehran.
City
Tehran
Postal code
Approval date
2015-07-29, 1394/05/07
Ethics committee reference number
SBMU2.REC.1394.48
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
Initiation 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
During of second stage of labor
Timepoint
At last of study
Method of measurement
Questionnaire
2
Description
During of first stage of labor
Timepoint
At last of study
Method of measurement
Questionnaire
3
Description
Neonatal Apgar
Timepoint
At last of study
Method of measurement
Questionnaire
4
Description
Use of oxytocin
Timepoint
At last of study
Method of measurement
Questionnaire
5
Description
Type of delivery
Timepoint
At last of study
Method of measurement
Questionnaire
Intervention groups
1
Description
The intervention group: acupressure applied in acupressure points BL32, BL60 and SP6 2 times daily for 30 minutes.
Category
Prevention
2
Description
The sham acupressure group: pressure was applied in ineffective point for 30 minutes 2 times a day.
Category
Prevention
3
Description
Control group: routine care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abaadi Hospital
Full name of responsible person
Nadia Hobi
Street address
Ferdose garden station, Molavi street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mahrokh Dolatian
Street address
School of Nursing and Midwifery, Niayesh Cross Road, Vali Asr Ave, Tehran
City
Tehran
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, 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
Fatemeh Mahmoudi Kohani
Position
MS Stedent Midwifery
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St, Shahid Chamran Highway, Tehran.
City
Tehran
Postal code
1985717443
Phone
+98 21 2243 9888
Fax
+98 21 2243 9889
Email
mahmodi2020@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery Shahid Beheshti University
Full name of responsible person
Shahnaz Tork Zahrani
Position
Academic Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr Ave, Tehran.
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2517
Fax
Email
zahranishahnaz@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
Fatemeh Mahmoudi Kohani
Position
MS Student Of Midwifery
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Velenjak St, Shahid Chamran Highway, Tehran.
City
Tehran
Postal code
Phone
+98 913 854 3127
Fax
Email
mahmodi2020@yahoo.com; mahmodi2020@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)