In this clinical trial, 280 eligible normal term pregnant women in the third stage of delivery at the obstetric unit of Assali Hospital Khoramabad were enrolled to compare the effect of Dill extracts and uterine massage in reduction of postpartum hemorrhage. The control group received only 20 units of oxytocin in 1000 ml dextrose5% and sodium chloride o.9% at the infusion rate of 2 ml/min. In the second group received the same treatment and they were asked to eat 4 gram Dill extracts with 10g sugar in 50 ml of warm water mix within 1 minute. The third group uterine massage alone for 30 minutes to form a circular uterine massage. The fourth group uterine massages with Dill extracts: Uterine massage for 30 minutes is the time addition 4 grams Dill extracts with 10 grams of sugar in 50 cc of warm water mixed drink parturient women for 1 minute. At the same time, mother lied on two layers of plastic and a cotton sheet then a pad was put on the perineum to absorb blood. All used pads and cotton sheets were weighted in first and second 30 minutes after placenta expulsion by" Sairan Iranian digital scale". Blood loss was determined by the difference between weight of each pad and cotton sheets before and after use. Each one gram increase in weight was considered equal to 1 ml blood. Vital sign were controlled every 15 minutes until one hour. Main outcome measure: Reduction of post partum hemorrhage.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302063081N3
Registration date:2013-02-25, 1391/12/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-25, 1391/12/07
Registrant information
Name
Parvin Asti
Name of organization / entity
Lorestan University Of Medical Seinces
Country
Iran (Islamic Republic of)
Phone
+98 66 1320 5603
Email address
asti.p@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research Loreastan University Of Medical Sciences
Expected recruitment start date
2012-03-13, 1390/12/23
Expected recruitment end date
2014-04-12, 1393/01/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Dill extracts and uterine massage in reduction of post partum hemorrhage
Public title
Comparison the effect of Dill extracts and uterine massage in reduction of post partum hemorrhage
Purpose
Prevention
Inclusion/Exclusion criteria
Prevention
Inclusion criteria were: age between 18-35years; parity 1-2; term pregnancy with a single living fetus; cephalic presentation; neonatal weight between 2500-4000 gram; not affected by any systemic disease; and finally normality of duration of the second and third stage of delivery. Exclusion criteria were: sever postpartum hemorrhage; history of bleeding disorders and surgery on the uterus, curettage, retention of placenta, third and fourth degree perineal lacerations, paired in such a way to prevent obesity is uterine massage lack of consent to participate in the study.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Country Committee for Medical Research Ethics
Street address
Azadi St., Avesta Park Ave, Vice Chancellor for Research and Technology of the Ministry of Health, Fifth Floor
City
Teharan
Postal code
Approval date
2012-03-13, 1390/12/23
Ethics committee reference number
55/پ90ك-1
Health conditions studied
1
Description of health condition studied
Postpartum hemorrhage
ICD-10 code
O72.1
ICD-10 code description
Haemorrhage following delivery of placenta
Primary outcomes
1
Description
Postpartum hemorrhage
Timepoint
First and second 30 minutes after placenta expulsion
Method of measurement
All used pads and cotton sheets were weighted in first and second 30 minutes after placenta expulsion by" Sairan Iranian digital scale "with sensitivity of 5 g. Blood loss was determined by the difference between weight of each pad and cotton sheets before and after use. Each one gram increase in weight was considered equal to 1 ml blood.
Secondary outcomes
1
Description
Pulse
Timepoint
Every 15 minutes until one hours
Method of measurement
Counting
2
Description
Blood pressure
Timepoint
Every 15 minutes until one hours
Method of measurement
Sphygmomanometer
Intervention groups
1
Description
Immediately after placenta expulsion, the control group received only 20 units of oxytocin in 1000 ml dextrose5% and sodium chloride o.9% at the infusion rate of 2 ml/min.
Category
Treatment - Drugs
2
Description
Immediately after placenta expulsion, second group received 20 units of oxytocin in 1000 ml dextrose5% and sodium chloride o.9% at the infusion rate of 2 ml/min addition 4 grams Dill extracts with 10 grams of sugar in 50 cc of warm water mixed drink parturient women for 1 minute.
Category
Treatment - Drugs
3
Description
Immediately after placenta expulsion, The third group uterine massage alone for 30 minutes to form a circular uterine massage.
Category
Treatment - Drugs
4
Description
Immediately after placenta expulsion, The fourth group uterine massages with Dill extracts: Uterine massage for 30 minutes is the time addition 4 grams Dill extracts with 10 grams of sugar in 50 cc of warm water mixed drink parturient women for 1 minute.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Asali Hospital related to Lorestan University of Medical Sciences
Full name of responsible person
Parvin Asti
Street address
Midwifery Department ,Nursing and Midwifery Faculty , Lorestan University of Medical Sciences, Kamalvakd
City
Khoramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research Loreastan University Of Medical Sciences
Full name of responsible person
Mohammad Hassan Kaedi
Street address
Vice Chancellor For Research Loreastan University Of Medical Sciences,Kamalvand
City
Khoramabad
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 Loreastan 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
Lorestan University of Medical Sciences
Full name of responsible person
Parvin Asti
Position
Master of Midwifery, Faculty member of Lorestan
Other areas of specialty/work
Street address
Midwifery Department, Nursing and Midwifery Faculty , Lorestan University of Medical,Kamalvand
City
Khoramabad
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0140
Email
Asti_P@yahoo.com, Asti.p@Lums.ac.ir
Web page address
www.Lums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University Of Medical Sciences
Full name of responsible person
Parvin Asti
Position
Master of Midwifery, Faculty member of Lorestan University Of Medical Sciences
Other areas of specialty/work
Street address
Midwifery Department, Nursing and Midwifery Faculty , Lorestan University Of Medical Sciences,Kamalvand
City
Khoramabad
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0140
Email
Asti_P@yahoo.com, Asti.p@Lums.ac.ir
Web page address
www.Lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University Of Medical Sciences
Full name of responsible person
Parvin Asti
Position
Master of Midwifery, Faculty member Of Lorestan University Of Medical Sciences
Other areas of specialty/work
Street address
Midwifery Department, Nursing and Midwifery Faculty , Lorestan University Of Medical Sciences,Kamalvand
City
Khoramabad
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0140
Email
Asti_P@yahoo.com, Asti.p@Lums.ac.ir
Web page address
www.Lums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)