Protocol summary

Study aim
Comparison of duration of latent and active phase of labor in women with and without nipple stimulation.
Design
randomization method is block randomization. the midwife who admits the patient writes the number in admit sheet and being in case or control group is determined with the resident.
Settings and conduct
the study will take place in Alzahra and Taleghani hospital of Tabriz
Participants/Inclusion and exclusion criteria
Term pregnant women with labor pain and cervical dilatation less than 3 centimeters.
Intervention groups
pregnant women in case group do nipple stimulation when they do not have uterine contraction , each stimulation lasts 3- minute and stimulates nipples intermittently
Main outcome variables
duration of active phase; duration of latent phase

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190304042912N1
Registration date: 2019-07-13, 1398/04/22
Registration timing: registered_while_recruiting

Last update: 2019-07-13, 1398/04/22
Update count: 0
Registration date
2019-07-13, 1398/04/22
Registrant information
Name
sanaz moosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 9161
Email address
musevis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-06, 1398/04/15
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of the effect of nipple stimulation in pregnant women admitted with labor pain in latent phase
Public title
evaluation of the effect of nipple stimulation in pregnant women admitted with labor pain in latent phase
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant term with labor pain cervical dilatation less than 3 cm
Exclusion criteria:
previous cesarean preeclampsia chorioamnionitis multifetal gestation macrosom fetus iugr fetus poly hydramnios
Age
From 16 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 95
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Evaluator of outcome and person who analyses are blind of intervention and group of patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics comittee of tabriz university of medical sciences
Street address
Tabriz university of medical sciences, golgasht Ave, Tabriz , Iran
City
tabriz
Province
East Azarbaijan
Postal code
5157815343
Approval date
2019-06-05, 1398/03/15
Ethics committee reference number
د/5/62/2743

2

Ethics committee
Name of ethics committee
ethics committee of department of obstetrics and gynecology in tabriz
Street address
Alzahra hospital, Artesh Ave, Tabriz , Iran
City
tabriz
Province
East Azarbaijan
Postal code
5157815343
Approval date
2019-03-01, 1397/12/10
Ethics committee reference number
5622743

Health conditions studied

1

Description of health condition studied
duration of labor
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
duration of latent phase
Timepoint
after intervention and delivery
Method of measurement
patient chart

Secondary outcomes

1

Description
duration of acute phase of labor
Timepoint
after intervention and delivery
Method of measurement
patient chart

Intervention groups

1

Description
Intervention group: nipple stimulation
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital, Taleghani hospital
Full name of responsible person
SANAZ MOUSAVI
Street address
Alzahra hospital, Artesh Ave.
City
tabriz
Province
East Azarbaijan
Postal code
5157815343
Phone
+98 41 3554 1221
Email
moosavisanaz@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
SANAZ MOUSAVI
Street address
ALZAHRA hospital, Artesh Ave
City
tabriz
Province
East Azarbaijan
Postal code
5157815343
Phone
+98 41 3331 5372
Email
moosavisanaz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
SANAZ MOUSAVI
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alzahra hospital- Artesh Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5157815343
Phone
+98 984135541221
Email
moosavisanaz@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
SANAZ MOUSAVI
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alzahra hospital- Artesh Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5157815343
Phone
+98 41 3554 1221
Email
moosavisanaz@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
SANAZ MOUSAVI
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alzahra hospital, Artesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5157815343
Phone
+98 41 3554 1221
Email
moosavisanaz@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Loading...