Pethidine increases the contraction of the uterus and possibly accelerate the delivery.The purpose of this study was evaluation the effect of Pethedin on duration of labor and type of delivery in nulliparous women. Material and Methods: In a double blind randomized controlled trial 90 nulliparous women participated in the study. After accurate determination of pregnancy age, participants were classified into two groups Pethedine and Placebo (Normal Saline) . The first group (Pethedine group=45 cases) received 50 mg Pethedin Intra Muscular. In the Placebo group (Normal Saline=45 cases) , an equal volume of Normal Saline was prescripted Intra Venous. The mean duration first and second stages, type of delivery and Apgar scour was recorded
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407016575N5
Registration date:2015-02-15, 1393/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-15, 1393/11/26
Registrant information
Name
Ashraf Direkvand-Moghadam
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7134
Email address
direkvand-a@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Ilam University of Medical Sciences
Expected recruitment start date
2013-04-14, 1392/01/25
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pethedin on duration of labor and type of delivery in nulliparous women
Public title
Effect of Pethedin on duration of labor and type of delivery in nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:18-35 years of old; nulliparous; singleton pregnancy; gestational age 38-40; without CPD; optimal care during pregnancy; blood pressure less than 140/90 mmHg; pulse 60-110; Body Mass Index 19/8-26 (kg/m) before pregnancy; intact of membrane; estimated fetal weight less than 4000 grams; exclusion criteria: Polyhydramnios; abnormal presentation; Preeclampsia; history of medical problems during and before pregnancy such as Asthma; Cardiovascular and Metabolic disease at the admission time
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ilam University of Medical Sciences
Street address
Ilam University of Medical Sciences
City
Ilam
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
(EC/91/H/102)
Health conditions studied
1
Description of health condition studied
The relationship between Pethedin with the duration of labor and type of delivery in nulliparous women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration of labor in nulliparus women
Timepoint
Start of admission to delivery
Method of measurement
Duration of labor according to minute
2
Description
Type of delivery in nulliparous women
Timepoint
Start of admission to delivery
Method of measurement
Divided into two groups normal vaginal deliveries and cesarean section
Secondary outcomes
empty
Intervention groups
1
Description
The Pethedin group received 50 mg Pethedin Intra Muscular.
Category
Treatment - Drugs
2
Description
The Placebo group received an equal volume of Normal Slaine Intra Venous.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mustafa Khomeini hospital, Ilam University of Medical Sciences
Full name of responsible person
Ashraf Direkvand-Moghadam
Street address
Ilam University of Medical Sciences
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Iraj Pakzad
Street address
Ilam University of Medical Sciences
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Ashraf Direkvand-Moghadam
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Ilam University of Medical Sciences
City
Ilam
Postal code
Phone
+98 84 3221 3171
Fax
Email
direkvand-a@medilam.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Ashraf Direkvand-Moghadam
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Ilam University of Medical Sciences
City
Ilam
Postal code
Phone
+98 84 3221 3171
Fax
+98 84 3221 3171
Email
direkvand-a@medilam.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Ashraf Direkvand-Moghadam
Position
MSc midwifery
Other areas of specialty/work
Street address
Ilam University of Medical Sciences
City
Ilam
Postal code
Phone
+98 84 3223 3171
Fax
+98 84 3223 3171
Email
direkvand-a@medilam.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)