Aim of this study comparison of frequency of cesarean section and the average of delivery phases between Epidural analgesia versus no analgesia in labor. This study is clinical trials and double blind.120 patients will divide in two groups. Women will done delivery with epidural anesthesia (4-6 milliliter Marcain 0/125 percent and single dose 5 micro gram Fentanyl and preservative dose Marcain 0/125 percent and 0/002 percent in 6-10 milliliter in hours) and women pregnant will perform delivery without analgesia. We will record incidence cesarean and mean of time of delivery phases after delivery.
Inclusion criteria: pregnant woman; single fetus; pregnant women candidates vaginal delivery; pregnant women candidates epidural; nuliparous; ASA class I and II; 37 to 42 weeks
Exclusion criteria: Mothers with more than one fetus; multiparty mothers; patients referring to urgency; Patients with topical anesthetics and narcotic; block placenta infection; failure in epidural anesthesia
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102420258N63
Registration date:2017-11-16, 1396/08/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-16, 1396/08/25
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor and Research, Arak University of Medical Sciences
Expected recruitment start date
2017-06-05, 1396/03/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of frequency of cesarean section and the average of delivery phases between Epidural analgesia versus no analgesia in labor
Public title
Comparison of frequency of cesarean section and the average of delivery phases between Epidural analgesia versus no analgesia in labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant woman; single fetus; pregnant women candidates vaginal delivery; pregnant women candidates epidural; nuliparous; ASA class I and II; 37 to 42 weeks
Exclusion criteria: Mothers with more than one fetus; multiparty mothers; patients referring to urgency; Patients with topical anesthetics and narcotic; block placenta infection; failure in epidural anesthesia
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Arak University Of Medical Sciences
Intervention group: Women will done delivery with epidural anesthesia (4-6 milliliter Marcain 0/125 percent and single dose 5 micro gram Fentanyl and preservative dose Marcain 0/125 percent and 0/002 percent in 6-10 milliliter in hours)
Category
Treatment - Drugs
2
Description
Control group: Delivery is performed without analgesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Maryam Shokrpour
Street address
Taleghani hospital, Emam Khomeini street
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences