Objective: A comparison between the effect of oral titrated misoprostol and intravenous oxitocine for labor induction in term pregnancies.
Design: Randomized clinical trial
Setting and conduct: Double blind
Participants: Inclusion criteria: age between 20-40 year old; reliable gestational age between 40-42 weeks; singleton pregnancy with cephalic presentation; BISHOP Score of more than 5; favorable pelvis.
Exclusion criteria: parity of more than 3, blood pressure equal or more than 160/110 mmHg; abnormal NST and any sign of fetal distress; urine protein of more than 2 gram in 24 hours; suspicious for HELLP syndrome; poly hydramnios; probable macrosomia; any vaginal bleeding; history of any surgery on uterus; prostaglandin use during present pregnancy and beginning of spontaneous uterine contractions.
Intervention: prescription of titrated oral misoprostol in one group and oxitocine in the other group.
Main outcome: number of deliveries during the first 24 hours.
Other outcomes: number of deliveries during 6-12-18 hours from the beginning of induction; duration of stage 1 , 2 and 3 of labor; interval between the beginning of induction up to the beginning of suitable contractions( 3 forceful contractions during 10 minutes); hyper stimulation; number of vaginal deliveries , instrumental deliveries and cesarean sections; indications for cesarean deliveries; fetal distress; neonatal Apgar Score; NICU admission; and duration of hospital stay for mother and baby.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403242624N13
Registration date:2014-09-09, 1393/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-09, 1393/06/18
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator.
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the effect of oral titrated solution of misoprostol and intravenous oxitocine for labor induction in term pregnancies.
Public title
Labor induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 20-40 year old; reliable gestational age between 40-42 weeks; singleton pregnancy with cephalic presentation; BISHOP Score of more than 5; favorable pelvis.
Exclusion criteria: parity of more than 3, blood pressure equal or more than 160/110 mmHg; abnormal NST and any sign of fetal distress; urine protein of more than 2 gram in 24 hours; suspicious for HELLP syndrome; poly hydramnios; probable macrosomia; any vaginal bleeding; history of any surgery on uterus; prostaglandin use during present pregnancy and beginning of spontaneous uterine contractions.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic comittee of Iran University of Medical Sciences
Street address
Hemmat highway, Chamran Cross
City
Tehran
Postal code
16117
Approval date
2014-07-28, 1393/05/06
Ethics committee reference number
93/د/105/ 2129
Health conditions studied
1
Description of health condition studied
cervical ripening
ICD-10 code
O30
ICD-10 code description
Maternal care related to the fetus and amniotic cavity and possible delivery problems
2
Description of health condition studied
induction of labor
ICD-10 code
O61
ICD-10 code description
Complications of labour and delivery.
3
Description of health condition studied
medical induction of labour
ICD-10 code
O61.0
ICD-10 code description
Failed medical induction of labour
4
Description of health condition studied
Delivery
ICD-10 code
O80
ICD-10 code description
Delivery
Primary outcomes
1
Description
Number of deliveries during the first 24 hours.
Timepoint
24 hours
Method of measurement
Data sheets
Secondary outcomes
1
Description
rout of delivery
Timepoint
---
Method of measurement
data sheets
2
Description
uterine hyperstimulation
Timepoint
every 30 minutes
Method of measurement
monitoring of uterine contractions- tocography
3
Description
fetal distress
Timepoint
every 15 minutes
Method of measurement
fetal heart rate monitoring with tococardiography
4
Description
neonatal Apgar Score
Timepoint
minute 1 and 5
Method of measurement
data sheets
5
Description
number of deliveries during 6-12-18 hours from the beginning of induction
Timepoint
6-12-18 hours from the beginning of induction
Method of measurement
data sheets
6
Description
duration of stage 1 , 2 and 3 of labor.
Timepoint
end of stage 1 , 2 and 3 of labor
Method of measurement
data sheets
7
Description
interval between the beginning of induction up to the beginning of suitable contractions( 3 forceful contractions during 10 minutes).
Timepoint
every 30 minutes
Method of measurement
data sheets
8
Description
indications for cesarean deliveries.
Timepoint
during cesarean deliveries
Method of measurement
data sheets
9
Description
NICU admission
Timepoint
After birth up to discharge.
Method of measurement
data sheets
10
Description
duration of hospital stay for mother and baby
Timepoint
admission , discharge.
Method of measurement
data sheets
Intervention groups
1
Description
administration of oral titrated solution of misoprostol. 200 microgram misoprostol will be solved in 200 mili liter water, and 20 cc of this solution will be prescribed every 2 hours. ( maximum 60 micro gram).
Category
Treatment - Drugs
2
Description
infusion of 2.5 mili units oxitocine per minute that will be doubled every 15 minutes. Maximum dose of oxitocine is 60 mili units per minute.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Teaching Hospital
Full name of responsible person
Maryam Kashanian
Street address
Molavi avenue, Molavi Cross.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research ,Iran University of Medical Sciences.
Full name of responsible person
Dr Seyed Javad Mousavi
Street address
Hemmat High way, Chamran Cross.
City
Tehran
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 ,Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor.
Other areas of specialty/work
Street address
Molavi avenue, Molavi Cross.
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
MD.
Other areas of specialty/work
Street address
Molavi avenue, Molavi Cross.
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Other areas of specialty/work
Street address
Molavi Avenue, Molavi Cross.
City
Tehran
Postal code
16117
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)