Abstract:
Objectives: Recently elective inductions of labor at term have increased dramatically which may be in part due to patient and clinicians desire to arrange a convenient time of delivery. Termination of pregnancy before emerging labor pain is an important concern. Because induction of labor is one of the most commonly performed obstetrical procedures clinicians all over the world investigate to find a safe technique for mother and neonate. Labor induction with PGE1 is one of the selections. Our objective was to compare vaginal delivery, maternal, fetal and neonatal complication between induction of labor with oxytocin and misoprostol.
Methods: we selected one hundred - two cases with term pregnancy , not in active labor, singleton pregnancy, vertex presentation, normal fetal heart rate reactivity and Bishop score<6, consented to participate in the study. Fifty-one of the cases were included in misoprostol group and a 100 µg misoprostol tablet was placed in the posterior vaginal fornix. Another 51 cases were included in oxytocin group. Labor characteristics, maternal and neonatal outcome were analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202018897N1
Registration date:2012-03-07, 1390/12/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-07, 1390/12/17
Registrant information
Name
Safoura Rouholamin
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1236 7001
Email address
s_rouholamin@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2008-12-21, 1387/10/01
Expected recruitment end date
2009-08-21, 1388/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of vaginal misoprostol tablet
and oxytocin in induction of labor at term pregnancy
Public title
Effect of misoprostol on labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: singleton live pregnancy at term(GA≥ 37week) in the cephalic presentation; absent of active labor; unfavorable cervix(Bishop scor≤6) and normal fetal heart rate tracing.
Exclusion criteria: known cephalopelvic disproportion; abnormal presentation; previous cesarean delivery or other type of uterine surgery; cervical cancer; fetal macrosomia; active herpes genitalia; multiparity and fetal anomaly.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor-Isfahan university of medical science
Street address
Pol felezi,motahari st. shahid beheshti hospital
City
Isfahan
Postal code
8184851153
Approval date
2008-11-05, 1387/08/15
Ethics committee reference number
387303
Health conditions studied
1
Description of health condition studied
Efficacy on induction of labor
ICD-10 code
O61.0
ICD-10 code description
Failed medical induction of labour
Primary outcomes
1
Description
Interval from induction to true labor
Timepoint
Vaginal exam for evaluation of dilatation and effacment
Method of measurement
By vaginal exam
2
Description
Interval from true labor to delivery
Timepoint
Vaginal exam for evaluation of dilatation and effacment q 1 hour
Method of measurement
By vaginal exam
3
Description
Interval from induction to delivery
Timepoint
Vaginal exam for evaluation of dilatation and effacment q 1 hour
Method of measurement
By vaginal exam
Secondary outcomes
1
Description
Rate of vaginal delivery
Timepoint
At delivery time and 48 hours afterthat
Method of measurement
By clinical evaluation and add to form
2
Description
Post partum complication
Timepoint
At delivery time and 48 hours afterthat
Method of measurement
By clinical evaluation and add to form
3
Description
Neonatal outcom
Timepoint
At delivery time and 48 hours afterthat
Method of measurement
By clinical evaluation and add to form
Intervention groups
1
Description
Insertion of 100 microgram vaginal misoprostol
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Medicine
Full name of responsible person
Vice chancellor for research, Isfahan university of medical science
Street address
Isfahan medical university, hezarjreeb street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Medicine
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
Faculty of medicin
Full name of responsible person
Dr.Rouholamin safoura
Position
Assistant professor
Other areas of specialty/work
Street address
Beheshti hospital, pol felezi
City
Isfahan
Postal code
Phone
+98 31123670015
Fax
Email
s _rouholamin@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of medicine (Isfahan medical university)
Full name of responsible person
Dr. zahra allameh
Position
Associate professor
Other areas of specialty/work
Street address
Beheshti hospital
City
Isfahan
Postal code
Phone
+91 33159672
Fax
Email
z_allameh@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)