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Comparing effect of the neuraxial painless vaginal delivery with vaginal delivery on fetal outcomes with due attention to newborns' APGAR scores in first, fifth and tenth minutes

Protocol summary

Summary
In current non-randomized, non-blinded single center study, we aim to evaluate neonates’ APGAR scores in first, fifth and tenth minutes, seeking for cardiopulmonary resuscitation, need for neonatal intensive care unit admission, alterations in fetal heart rate, breastfeeding time, discharge time and neonatal reflexes in first day of birth in both painless and normal vaginal delivery groups. In current interventional study, 300 women admitted to delivery room of the Taleghai hospital divided to two groups. Women who are capable to perform vaginal delivery and gave their informed consent, will enroll study. In addition, patients who cannot remain immobile during procedure and do not provide consent to participate in study, excluded. One of the neuraxial painless delivery methods such as spinal, epidural and combined spinal-epidural, selected for each patient with due attention to woman parity and delivery phase and APGAR scores during first, fifth and tenth minutes will be recorded in a designed questionnaire. Afterward, using Mann Withney U statistical test, statistical differences between groups will be obtained.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010325821N1
Registration date: 2016-07-14, 1395/04/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-14, 1395/04/24
Registrant information
Name
Hojjat Pourfathi
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1994
Email address
pourfathih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and development of Tabriz University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-07-20, 1395/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of the neuraxial painless vaginal delivery with vaginal delivery on fetal outcomes with due attention to newborns' APGAR scores in first, fifth and tenth minutes
Public title
Newborns first, fifth and tenth minutes APGAR scores during painless delivery using neuraxial analgesia compared to normal vaginal delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: There is a possibility of natural birth; There is labor pain and active delivery phase; mother's consent to reduce delivery pain; spouse consent. Exclusion criteria: mother's disinclination to participate; Inability to maintain immobility during procedure; Coagulation disorders and defects in homeostasis; Increased intracranial pressure for any reason; Frank infection at the needle site; Hypersensitivity to local anesthetics or other medications using in this methods; Acute lesions of the central nervous system; Maternal hemodynamic instability (hypovolemia, hypotension); Heart diseases that cardiac output is severely limited; fetal distress.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of the research and technology department, Tabriz University of Medical sciences
Street address
Research department- Daneshghah street- Tabriz
City
Tabriz
Postal code
Approval date
2016-02-08, 1394/11/19
Ethics committee reference number
IR.TBZMED.REC.1394.1039

Health conditions studied

1

Description of health condition studied
Delivery pain and its effect on fetal health condition
ICD-10 code
P04.0
ICD-10 code description
Fetus and newborn affected by maternal anaesthesia and analgesia in pregnancy, labour and delivery

Primary outcomes

1

Description
pain
Timepoint
before the intervention, Immediately after the intervention, Every 5 minutes until delivery, Immediately after delivery
Method of measurement
visual analogue scale tool

2

Description
Apgar
Timepoint
first, fifth and tenth minutes after birth
Method of measurement
Apgar scoring system

3

Description
Fetal heart rate
Timepoint
before the intervention, Immediately after the intervention, Every 5 minutes until delivery, Immediately after delivery
Method of measurement
physical examination

Secondary outcomes

1

Description
hypotention
Timepoint
before the intervention, immediately after the intervention, every 5 minutes until delivery, immediately after delivery
Method of measurement
Sphygmomanometer tool

2

Description
Oxygen saturation level
Timepoint
before the intervention, immediately after the intervention, every 5 minutes until delivery, immediately after delivery
Method of measurement
pulse oximeter

3

Description
The first time of breadtfeeding
Timepoint
Immediately after delivery
Method of measurement
Physical examination

4

Description
pain
Timepoint
before the intervention, immediately after the intervention, every 5 minutes until delivery, immediately after delivery
Method of measurement
visual analogue scale tool

Intervention groups

1

Description
Neuraxial method: during delivery 25 to 50 microgram intrathecal fentanyl injection as opioid combined with 2.5 milligram bupivacaine to enhance analgesia quality and duration
Category
Prevention

2

Description
Control group: vaginal delivery will be performed without intrathecal opioid injection.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Taleghani hospital
Full name of responsible person
Dr. Hojjat Pourfathi
Street address
Taleghani hospital, Rah ahan square, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
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 of Tabriz 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
Medicine faculty
Full name of responsible person
Hassan Soleiman Pour
Position
Vice Chancellor for research of Medicine faculty
Other areas of specialty/work
Street address
Tabriz Medicine faculty, Daneshgah Street
City
Tabriz
Postal code
Phone
+98 41 3336 4667
Fax
Email
soleimanpourh@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hojjat Pourfathi
Position
Assistant Professor in Anesthesiology
Other areas of specialty/work
Street address
Talghani hospital, Rah ahan square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3441 2000
Fax
Email
pourfathih@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences 
Full name of responsible person
Dr. Hojjat Pourfathi
Position
Assistant Professor in Anesthesiology
Other areas of specialty/work
Street address
Talghani hospital, Rahahan square
City
Tabriz
Postal code
Phone
+98 41 3441 2000
Fax
+98 41 3334 1994
Email
pourfathih@tbzmed.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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