Comparison of the effect of nipple stimulation(using pump) and oxytocin infusion on the length and the bleeding of third stage of labour, bleeding and postpartum Anemia.
This study will be conducted to examine the impact of nipple stimulation by pump with oxytocin infusion on the duration and the amount of the third stage bleeding and postpartum anemia. This randomized clinical trial study will be performed on 108 women aged between 18 to 35 years who would refer to Sina hospital in order to natural delivery with the amount of hemoglobin above 11, the first and second pregnancy, singleton pregnancy, gestational age between 37 to 42 weeks, without the history of cesarean delivery and postpartum bleeding. They are put randomly 54 patients in the control group and 54 people in the intervention group by simple random method. Hematocrit and hemoglobin would be measured at the time of acceptance in the both groups of intervention and control. In the intervention group, it will be done the nipple stimulation by the special pump for 5 minutes alternately for each breast and a total of 10 minutes for breasts immediately after birth and cutting the umbilical cord. In the control group, a routine care will take place immediately after delivery by infusion of 20 units of oxytocin in 1000 ml serum. It will be measured the duration and the amount of bleeding in the third stage of labor, postpartum hemorrhage,Hematocrit and Hemoglobin just 24 hours after delivery in both groups of intervention and control.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050722146N1
Registration date:2015-11-04, 1394/08/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-04, 1394/08/13
Registrant information
Name
Elham Dashtinezhad
Name of organization / entity
Jundishapur university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 7543
Email address
dashtinejad.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of nipple stimulation(using pump) and oxytocin infusion on the length and the bleeding of third stage of labour, bleeding and postpartum Anemia.
Public title
The effect of nipple stimulation on bleeding of third stage of labor and postpartum Anemia.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria to the research : The age between 18 and 35 years; Singleton pregnancy; Gestational age between 37 to 42 weeks; Normal blood pressure; First and second delivery;The amount of hemoglobin before labor to be more than 11 g per dL; BMI to be between 20 to 30 kilograms per square meter; Weight of the baby to be between 2500 to 4000 gr; Normal vaginal delivery.
Exclusion criteria from the research: Women with placental abruption and placenta previa pregnancy; Women who have abnormal labor progress; Women who have had uterine surgery and cesarean; Women with a history of internal and underlying medical conditions; Women who need oxytocin for augmentation of labor; Women who have had postpartum hemorrhage in previous pregnancy; If the pregnancy to be along with oligo or poly hydramnios; If there has been fetal distress; In case of severe postpartum hemorrhage that requires more interventions; Women who had abortions.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sampling is being done through by simple random method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz,Jundishapour University of Medical Sciences
Street address
Ahvaz, Golestan Highway,Ahvaz Jundishapour University of Medical Sciences
City
Ahvaz
Postal code
6135715794
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
IR.AJUMS.REC.1394.86
Health conditions studied
1
Description of health condition studied
Bleeding in postpartum period.
ICD-10 code
O72.0
ICD-10 code description
Haemorrhage after delivery of fetus or infant
Primary outcomes
1
Description
Bleeding postpartum
Timepoint
After delivery, till 24 hours after delivery
Method of measurement
Higham chart
2
Description
postpartum Anemia
Timepoint
At the time of admission and 24 hours after delivery
Method of measurement
Hb; Hct Test
3
Description
Length of third stage of labour
Timepoint
Third stage of labour
Method of measurement
Minute
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
In the intervention group :Nipple stimulation/ 10 minutes for each nipples via pump/ after delivery.
Category
Other
2
Description
In the control group:Oxytocin infusion/20 units in 1000 milliliter at 10 cc per minute/ after delivery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Elham dashtinezhad
Street address
Kut Abdullah Road, Not far from the Alley station,Sina Hospital, Ahvaz, Iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for reserch of ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Elham Dashtinezhad
Street address
Ahvaz Jundishapour University of Medical Sciences,Opposite the central building, Vice Chancellor for Research, Ahvaz
City
Ahvaz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reserch of ahvaz Jundishapour 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 Jundishapour University of Medical Sciences
Full name of responsible person
Elham Dashtinezhad
Position
Master of Midwifery
Other areas of specialty/work
Street address
Golestan Highway, Ahvaz Jundishapour University of Medical Sciences, School of nursing and midwifery, Ahvaz
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
Elham_dashtinezhad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Parvin Abedi
Position
PhD
Other areas of specialty/work
Street address
Golestan Highway, Ahvaz Jundishapour University of Medical Sciences, School of nursing and midwifery, Ahvaz
City
Ahvaz
Postal code
6135715794
Phone
+98 61333738331
Fax
+98 61 3373 8333
Email
Prvinabedi@ymail.com
Web page address
http://fnursing.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences, school of nursing and midwifery
Full name of responsible person
Elham Dashtinezhad
Position
Master of Midwifery
Other areas of specialty/work
Street address
Golestan Highway, Ahvaz Jundishapour University of Medical Sciences, School of nursing and midwifery, Ahvaz
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
Elham_Dashtinezhad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)