Protocol summary

Summary
َAims: to compare vaginal delivery pain score in both groups Methods: In this single-blinded, randomized control trial,61primigravid singleton women with full-term pregnancy candidate for normal vaginal delivery, were entered the trial and divided in to pethedine (A) and paracetamol (B) group.At the time of admission, age and body mass index of mother and gestational age based on last day of period were recorded. In both groups, intramuscular promethasine and hyosine were administered to each patient at the first stage of delivery. Since beginning of active phase of delivery (50 mm of cervical dilatation and 100 % effacement), patients in group A received 50mg intramuscular pethedine injection. At the same time patients in group B, received an intravenous solution infusion containing 1000mg paracetamol and 300 cc of normal saline. After child birth, average labor pain was assessed using Visual Analogue Scale (VAS) by direct questioning from patient in both groups.Apgar score of neonate, duration of labor and incidence of drug complications in 24 hours after delivery were recorded in each group. Primaryout come variable: labour pain score secondary outcome variable: neonate Apgarscore, drug side effects inclusion criteria: primigravid singleton women with fullterm pregnancy (gestational age more than 37 weeks based on ultrasound findings) candidated for normal vaginal delivery exclusion criteria:were history of cardiac, liver and renal disease, anti-convulsive medication consumption, malpresentation of fetus, abnormal fetal monitoring during labor and multiple gestations

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201207215506N5
Registration date: 2012-09-24, 1391/07/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-09-24, 1391/07/03
Registrant information
Name
Mohamadhasan Abdollahi
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1826 0277
Email address
mhabdollahi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-07-05, 1391/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intravenous paracetamol versus intramuscular pethidine in relief of labor pain in primigravid women
Public title
Painless vaginal delivery
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: primigravid singleton women with fullterm pregnancy (gestational age more than 37 weeks based on ultrasound findings) candidated for normal vaginal delivery exclusion criteria:were history of cardiac, liver and renal disease, anti-convulsive medication consumption, malpresentation of fetus, abnormal fetal monitoring during labor and multiple gestations
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd University of Medical Sciences Ethics Committee
Street address
Bahonar sq.
City
Yazd
Postal code
Approval date
2012-02-04, 1390/11/15
Ethics committee reference number
140725

Health conditions studied

1

Description of health condition studied
vaginal delivery with vertex presentation
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery

Primary outcomes

1

Description
Labor pain
Timepoint
Immediately after child birth
Method of measurement
Visual analogue scale

Secondary outcomes

1

Description
Neonatal Apgar score
Timepoint
Immediately and 5 minutes after child birth
Method of measurement
Apgar score table

2

Description
Medical complication
Timepoint
24 hours after delivery
Method of measurement
Study questionarie

Intervention groups

1

Description
Since beginning of active phase of delivery (50 mm of cervical dilatation and 100 % effacement), patients in group control received 50mg intramuscular pethedine injection.
Category
Treatment - Drugs

2

Description
Intervention group: Since beginning of active phase of delivery (50 mm of cervical dilatation and 100 % effacement), patients in this group received an intravenous solution infusion containing 1000mg paracetamol and 300 cc of normal saline.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mojibian hospital
Full name of responsible person
Street address
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Hasan Mozaffari
Street address
Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hassan Abdollahi
Position
Assistant professor of anesthesiology group
Other areas of specialty/work
Street address
afshar hospital
City
Yazd
Postal code
Phone
+98 35 1826 0277
Fax
Email
mhabdollahi@yahoo.co.uk; mhabdollahi@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohamad Hassan Abdollahi
Position
Assistant prefessor of anesthesiology group
Other areas of specialty/work
Street address
Afshar hospital
City
Yazd
Postal code
Phone
+98 35 1826 0277
Fax
Email
mhabdollahi@yahoo.co.uk; mhabdollahi@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohamadhasan Abdollahi
Position
Anesthesilogy group professor
Other areas of specialty/work
Street address
Jomhoori blv., Afshar heart hospital
City
Yazd
Postal code
Phone
Fax
Email
mhabdollahi@ssu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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