Objectives: To assess the effect of painless vaginal delivery versus normal vaginal delivery on maternal and neonatal outcomes in pregnant women.
Design: a clinical trial.
Setting and conduct: The eligible pregnant refering to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) gestational age of 37 weeks or over; (b) being eligible for vaginal delivery.
Exclusion criteria: (a) having diabetes, cardiovascular diseases, or intracranial diseases; (b) having gestational diabetes, preeclampsia, or macrosomia; (c) coagulation disorders; (d) dermal infection on the location of epidural anesthesia; (e) non-treated bacteremia.
Intervention group: (a) epidural anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose; (b) spinal anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose; (c) combined anesthesia including epidural anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose and spinal anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose.
Control group: Without receiving anesthesia medications.
Primary outcome: (a) measuring the duration of the first and second stages of vaginal delivery after intervention using Friedman curve; (b) measuring episiotomy pain 6 and 12 hours after vaginal delivery using visual analog scale (VAS); (c) assessing Apgar score at the first and fifth minutes after birth through physical examination.
Secondary outcome: (a) assessing hyperthermia at 4, 8, and 12 hours after vaginal delivery using oral thermometer; (b) assessing headache 12 hours after vaginal delivery using visual analog scale (VAS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508259014N77
Registration date:2015-09-08, 1394/06/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-08, 1394/06/17
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-06-15, 1394/03/25
Expected recruitment end date
2016-06-14, 1395/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of painless vaginal delivery versus normal vaginal delivery on maternal and neonatal outcomes in pregnant women: a clinical trial
Public title
Effect of painless vaginal delivery versus normal vaginal delivery on maternal and neonatal outcomes in pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: (a) gestational age of 37 weeks or over; (b) being eligible for vaginal delivery.
Exclusion criteria: (a) having diabetes, cardiovascular diseases, or intracranial diseases; (b) having gestational diabetes, preeclampsia, or macrosomia; (c) coagulation disorders; (d) dermal infection on the location of epidural anesthesia; (e) non-treated bacteremia.
Age
From 15 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
168
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The eligible pregnant women who are willing to have painless vaginal delivery will be assigned to the intervention group and those women who are not willing to have painless vaginal delivery will be assigned to the control group.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-08-15, 1394/05/24
Ethics committee reference number
IR.UMSHA.REC.1394.269
Health conditions studied
1
Description of health condition studied
Vaginal delivery
ICD-10 code
O66
ICD-10 code description
Other obstructed labour
Primary outcomes
1
Description
measuring the duration of the first and second stages of vaginal delivery
Timepoint
after intervention
Method of measurement
using Friedman curve
2
Description
measuring episiotomy pain
Timepoint
6 and 12 hours after vaginal delivery
Method of measurement
using visual analog scale (VAS)
3
Description
) assessing Apgar score
Timepoint
at the first and fifth minutes after birth
Method of measurement
through physical examination
Secondary outcomes
1
Description
assessing hyperthermia
Timepoint
at 4, 8, and 12 hours after vaginal delivery
Method of measurement
using oral thermometer
2
Description
assessing headache
Timepoint
12 hours after vaginal delivery
Method of measurement
using visual analog scale (VAS)
Intervention groups
1
Description
epidural anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose
Category
Prevention
2
Description
spinal anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose
Category
Treatment - Drugs
3
Description
combined anesthesia including epidural anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose and spinal anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose
Category
Treatment - Drugs
4
Description
Without receiving anesthesia medications
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Nahid Radnia
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Fatemieh Hospital
Full name of responsible person
Dr Nahid Radnia
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
n.radnia@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Nahid Radnia
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
n.radnia@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)