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Comparison of the effectiveness of acetaminophen and pethidine in the first stage of labor on reducing the pain and maternal complications of primigravid women

Protocol summary

Study aim
Comparison of the efficacy of acetaminophen and pethidine in reducing the pain of the first stage of labor and the maternal complications
Design
Clinical trial with two interventional groups, community based and pragmatic, with parallel groups, one blinded, randomised
Settings and conduct
Prevention, Maternity of Niknafas Hospital, for both groups from the beginning of the active phase of labor (dilatation 4 cm), the administration of the drug (acetaminophen or pethidine) will begin according to the intervention group, the subject and the person evaluating the variables on which individual to which group Allocated, will not be informed.
Participants/Inclusion and exclusion criteria
inclusion criteria: term pregnant women requesting a reduction in labor pain, single with cephalic presentation, No known fetal growth disorder or abnormalities; exclusion criteria: history of medical illness (cardiac, hepatic, renal, pulmonary), preeclampsia, diabetes, drug abuse, acetaminophen and opioid sensitivity, G6PD deficiency), cesarean section history.
Intervention groups
First Intervention group receiving 100 mg acetaminophen in 100 cc serum ringer lactate within 15 minutes and second intervention group receiving 50 mg pethidine within 2 minutes
Main outcome variables
Pain,duration of delivery, maternal complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190202042595N1
Registration date: 2019-02-13, 1397/11/24
Registration timing: registered_while_recruiting

Last update: 2019-02-13, 1397/11/24
Update count: 0
Registration date
2019-02-13, 1397/11/24
Registrant information
Name
Masoume Khammar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0038
Email address
masoume.khammar@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-24, 1397/10/03
Expected recruitment end date
2019-12-24, 1398/10/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of acetaminophen and pethidine in the first stage of labor on reducing the pain and maternal complications of primigravid women
Public title
The effect of acetaminophen and pethidine on reducing the pain of the first stage of labor and its complications in primipara women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Single with cephalic presentation Pregnant women requesting a reduction in labor pain
Exclusion criteria:
Underlying disease(cardiac, hepatic, renal, pulmonary) Preeclampsia Diabetes Drug abuse Sensitization to acetaminophen and opioids G6PD deficiency Cesarean section history
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Random blocking and hiding the assignment of the type of intervention by writing the type of intervention on paper and placing in sealed envelopes that are numbered sequentially.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant and the person evaluating the variables on which each individual is assigned will not be informed and for hiding the assignment of the type of intervention, the title of the intervention will be written on the paper, and the sealed envelopes are sequentially numbered and placed inside the envelope.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Refsanjan University of Medical Sciences
Street address
Ethics Committee, Rafsanjan University of Medical Siences, Emam Ali Blvd., Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-12-25, 1397/10/04
Ethics committee reference number
IR.RUMS.REC.1397.168

Health conditions studied

1

Description of health condition studied
Delivery
ICD-10 code
o80
ICD-10 code description
Single spontaneous delivery

Primary outcomes

1

Description
pain
Timepoint
Before drug administration, 30 minutes, 1, 2, 3 and 4 hours after drug administration
Method of measurement
Visual analog scale(VAS) by graded ruler (0 to 10), which zero is painless and 10 most severe pain states

2

Description
Maternal complications
Timepoint
From the time of drug injection to 4 hours after delivery
Method of measurement
Nausea, vomiting, drowsiness, respiratory depression

3

Description
Duration of the first stage of labor
Timepoint
Distilation time of 4 cm to complete dilatation
Method of measurement
minute

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention group: Acetaminophen receptor, 100 mg of acetaminophen in 100 cc serum ringer lactate within 15 minutes
Category
Prevention

2

Description
Second Intervention group: Pethidine, 50 mg pethidine within 2 minutes
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Maternity of Niknafas hospital
Full name of responsible person
Masoume Khammar
Street address
Niknafas Hospital, Shohada St.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3426 9380
Email
masoume.khammar@rums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Ali Ansari
Street address
Research committee, Rafsanjan University of Medical Sciences, Emam Ali Blvd.
City
Kerman
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 6961
Email
dr.ansari@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Masoume Khammar
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternity of Niknafas Hospital, Shodaha St.
City
Kerman
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
masoume.khammar@rums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Masoume Khammar
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shohada St.
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
Masoume.khammar@rums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Masoume Khammar
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shohada St.
City
Kerman
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
masoume.khammar@rums.ac.ir

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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