Protocol summary

Study aim
Effect of analgesia with intravenous remifentanil versus intravenous pethidine on maternal and neonatal complications and maternal satisfaction with labor during active phase of labor
Design
Two arm parallel group randomised trial with blinded patients and outcome assessment
Settings and conduct
The research population was pregnant women referred to normal delivery in the Shahid Ayat Taleghani Hospital. Pregnant women, in the age range of 18 to 45 years old with a gestational age of 37 to 42, cephalalgia, lack of drug addiction, absence of malformation or disease in mother and fetus will be selected.Participants in the study, including a patient, an analyzer who will be analyzed patient information, will be unaware of the study program.
Participants/Inclusion and exclusion criteria
Pregnant women, in the age range of 18 to 45 years old with a gestational age of 37 to 42, cephalalgia, lack of drug addiction, absence of malformation or disease in mother and fetus will be selected, and if they receive any analgesic drug within three hours Before starting the study, they will be excluded from the study.
Intervention groups
Two groups 60,peittidine intravenous analgesia and analgesia will be allocated by the intravenous injection of Remifentanil. In the anesthetic group with pethidine, 25 mg / day of the drug will be diluted with 4 cc distilled water (2-3 minutes). Intervention in the analgesic group with the injection of remi-fentanyl, 10-5 micrograms of remifentanil, will be started by anesthetist for intravenous infusion.
Main outcome variables
The pain in the lower part of the lumbar will be measured once before the intervention and then at 5, 10, 20, 30 minutes after intervention and then every hour by inserting the maternal finger across the ruler in both groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191219045802N1
Registration date: 2020-07-29, 1399/05/08
Registration timing: registered_while_recruiting

Last update: 2020-07-29, 1399/05/08
Update count: 0
Registration date
2020-07-29, 1399/05/08
Registrant information
Name
leila kafshdooz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3525 7369
Email address
leilakaf@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-19, 1399/04/29
Expected recruitment end date
2020-08-19, 1399/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of analgesia with intravenous remifentanil versus intravenous pethidine on maternal and neonatal complications and maternal satisfaction with labor during active phase of labor
Public title
Effect of analgesia with intravenous remifentanil versus intravenous pethidine on maternal and neonatal complications and maternal satisfaction with labor during active phase of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women age range of 18 to 45 years old cephalalgia lack of drug addiction absence of malformation or disease in mother and fetus gestational age of 37 to 42
Exclusion criteria:
multiple pregnancy cesarean history
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated into groups,according to simple randomization list.Tables of random numbers will be used.All patients were randomly assigned into tow groups after obtaining the criteria for entering the study randomly into two groups . Pettidine intravenous analgesia and analgesia will be allocated by the intravenous injection of Remifentanil.
Blinding (investigator's opinion)
Single blinded
Blinding description
participants outcome assessors
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Attar neishaboori
City
Tabriz
Province
East Azarbaijan
Postal code
51367
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.TBZMED.REC.1399.032

Health conditions studied

1

Description of health condition studied
Labour Analgesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain
Timepoint
The pain in the lower part of the lumbar will be measured once before the intervention and then at 5, 10, 20, 30 minutes after intervention and then every hour by inserting the maternal finger across the ruler in both groups.
Method of measurement
visual analogue pain instrument

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Pittidine intravenous analgesia. In the anesthetic group with pethidine, 25 mg / day of the drug will be diluted with 4 cc distilled water (2-3 minutes).
Category
Treatment - Drugs

2

Description
Control group: Remifentanil Intervention in the analgesic group with the injection of remi-fentanyl, 10-5 micrograms of remifentanil, will be started by anesthetist for intravenous infusion.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Ayat ... Taleghani Hospital
Full name of responsible person
Hojjat Pourfathi
Street address
Attar neishabouri
City
Tabriz
Province
East Azarbaijan
Postal code
51367
Phone
+98 41 3337 4617
Email
leilakaf@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Samiei
Street address
Attar Neishaboori
City
Tabriz
Province
East Azarbaijan
Postal code
51367
Phone
+98 41 3337 4617
Email
leilakaf@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dr Hojjat Pourfathi
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Kafshdooz
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Medical Genetics
Street address
Attarneishaboori
City
Tabriz
Province
East Azarbaijan
Postal code
51367
Phone
+98 41 3337 4617
Email
leilakaf@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hojjat Pourfathi
Position
Consultant, Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Attar neishabouri
City
Tabriz
Province
East Azarbaijan
Postal code
51367
Phone
+98 41 3337 4617
Email
Hojjatpourfathi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Kafshdooz
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Medical Genetics
Street address
Sheshgelan
City
Tabriz
Province
East Azarbaijan
Postal code
51367
Phone
+98 41 3525 7369
Fax
Email
leilakaf@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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