A comparison between induction of labor with 3 methods of titrated oral misoprostol, constant dose of oral misoprostol and folly catheter with extra amniotic saline infusion (EASI), in women with unfavorable cervix.
Objective:Comparison between induction of labor with 3 methods of titrated oral misoprostol, constant dose of oral misoprostol and folly catheter with extra amniotic saline infusion (EASI), in women with unfavorable cervix.
Design:Clinical trial.
Setting and conduct:non randomized, not blind.
Participants:Pregnant women with inclusion criteria: maternal age between 18-40 years old; gestational age of more than 37 weeks; singleton; cephalic presentation; intact membrane and Bishop Score of less than 6. Exclusion criteria were any sign of fetal distress, placenta previa and any vaginal bleeding of more than bloody show, history of any surgery on uterus including cesarean section, and known uterine anomaly, intra uterine fetal death, and known hypersensitivity to misoprostol.
Intervention:induction of labor with titrated oral misoprostol, constant dose of oral misoprostol and folly catheter with extra amniotic saline infusion (EASI)
Main outcome:The main outcome was the number of vaginal deliveries during the first 24 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702282624N22
Registration date:2017-04-03, 1396/01/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-03, 1396/01/14
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
2014-04-05, 1393/01/16
Expected recruitment end date
2015-05-06, 1394/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between induction of labor with 3 methods of titrated oral misoprostol, constant dose of oral misoprostol and folly catheter with extra amniotic saline infusion (EASI), in women with unfavorable cervix.
Public title
Induction of labor with 3 different methods.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : maternal age between 18-40 years old; gestational age of more than 37 weeks ; singleton, cephalic presentation, intact membrane and Bishop Score of less than 6. Exclusion criteria : any sign of fetal distress; placenta previa and any vaginal bleeding of more than bloody show; history of any surgery on uterus including cesarean section; known uterine anomaly; intra uterine fetal death, and known hypersensitivity to misoprostol.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
116
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 Iran.University of Medical Sciences
Street address
Hemmat highway, Chamran Cross
City
Tehran
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
92/د/1345
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
O00-O99
ICD-10 code description
Pregnancy, childbirth and the puerperium
2
Description of health condition studied
Outcome of delivery
ICD-10 code
Z37
ICD-10 code description
Outcome of delivery
Primary outcomes
1
Description
Delivery during the first 24 hours after intervention.
Timepoint
24 hours
Method of measurement
Data sheets
Secondary outcomes
1
Description
duration of the stages of labor
Timepoint
1 hour
Method of measurement
Data sheets
2
Description
The adverse effects in mothers.
Timepoint
each hour
Method of measurement
Data sheets
3
Description
The adverse effects in neonates.
Timepoint
After birth up to discharge.
Method of measurement
Data sheets
Intervention groups
1
Description
In oral titrared misoprostol group:
200µg misoprostol tablet will be solved in 200 milliliter of water (this solution is stable in the room temperature and contains 1µg misoprostol in 1mlit of solution). First, 20 milt (20µg) of misoprostol will be administered hourly for 4 hours. Then in spite of not having good contractions, 40 milt (40µg) of misoprostol solution will be administered every 1 hour for 4 doses and will be repeated after 4 hours with 60mlit (60µg) of misoprostol solution for a maximum of 4 doses (in total 480µg).
Category
Treatment - Drugs
2
Description
In oral misoprostol group, 50µg misoprostol will be administered and women will be followed up to 4 hours. FHR and uterine contractions will be checked hourly. In the cases of not having suitable contractions after 4 hours, another 50 µg of misoprostol will be administered every 4 hours until obtaining good contractions or up to maximum 6 doses (300 µg totals). Then the women will be followed up to delivery.
Category
Treatment - Drugs
3
Description
In the EASI group, folly catheter of number 18 was introduced through cervical canal and was filled with 30mlit distilled water and was fixed above the internal cervical OS, and was connected to normal saline solution. The normal saline was entered the uterus with the rate of 30 drops per minute. After expulsion of folly catheter, oxytocin was started in the amount of 25 milliunits per minute and was increased every 15 minutes up to 40 milliunits 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 Road.
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 Ali Javad Mousavi
Street address
Hemmat High way, Junction of Chamran Highway.
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 Road.
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
Professor
Other areas of specialty/work
Street address
Molavi avenue, Molavi Cross Road.
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 Road.
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)