There are many ways to induce labor. This study compared the therapeutic effect of oxytocin (Oxy Tocip made in Iran with the external type called oxytocin) in the induction of labor in the Term and post term pregnancy. In this study, 200 pregnant women with a live fetus and cephalic presentation and more than 37 weeks gestational age are examined by a specialist and they will be included if the Bishop score is less than 4 and there are no uterine contractions. Exclusion criteria are uterine contractions, bleeding, abnormal fetal presentation, multiple and irregular fetal heart rate. Participants are randomly divided into two groups. Oxytocin 10 units in 1000 cc of serum Ringer is started and will be added every 15 minutes to reach a maximum of 40 mu / min. The induction of cervical dilatation and effacement during the first 30 minutes of active labor and every 15 minutes during the second stage of labor is controlled to determine the progress of labor. The primary outcome of the Labor is mean time between induction and delivery time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011275181N3
Registration date:2012-01-12, 1390/10/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-12, 1390/10/22
Registrant information
Name
Batool Rashidi
Name of organization / entity
Vali E Asr Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9320
Email address
bhrashidi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Drug costs will be paid by the Caspian Company.
Expected recruitment start date
2011-04-09, 1390/01/20
Expected recruitment end date
2012-04-08, 1391/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the use of oxytocin (Iranian-made and foreign) in the induction of labor.
Public title
Comparing the Oxytocin made in Iran with Oxytocin from foreign country for induction of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: one Fetal pregnancy; Cephalic presentation; intact amniotic membrane; Reactive NST; less than 3 uterus contraction per 10 minutes. Exclusion criteria: regular contraction (more than 6 contraction per hours); fetal death; Amniotomy contra indication; mother age less than 18 years; previous C/S; Multiparty (>3); Chorioamniotit; Asthma history; Multiple gestation; Placenta previa; Non Cephalic presentation; Glucoma; Vaginal bleeding; sensitivity to Prostoglandin; irregular in fetal heart rate; contra indication of vaginal delivery.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research,Tehran University of Medical Sciences
Street address
Bulding of Vice Chancellor for Research, Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2009-12-20, 1388/09/29
Ethics committee reference number
9992
Health conditions studied
1
Description of health condition studied
Long labor
ICD-10 code
O63
ICD-10 code description
Long labour
Primary outcomes
1
Description
Cesarian Section
Timepoint
at the end of induction of labor
Method of measurement
C/S or vaginal delivery
Secondary outcomes
1
Description
Duration of labor induction
Timepoint
Since the beginning of induction to delivery time
Method of measurement
Based on time
2
Description
Duration of first labor period
Timepoint
begining of induction until delivery time
Method of measurement
based on hours
3
Description
During the second stage of labor
Timepoint
Onset of contractions to full cervical dilatation
Method of measurement
Based on time
4
Description
uterine hyper stimulation
Timepoint
Time of contraction is more than two minutes.
Method of measurement
Based on an specialist examination
Intervention groups
1
Description
The group 1 (oxytocin), First 10 units oxytocin spilled in 1000 cc of blood Ringer (2/5mu/min) Then four drops per minute infusion rate 2 / 5 is increased to the maximum mu / min 40 in.
The same amount will continue. After a good start uterine contractions, vaginal examination will be done if the patient Prom every hour and in rupture of the amniotic soc every 2 hour and every half hour inuterine contractions. mother's vital signs will be controlled before oxytocin induction and then each hour. If signs of fetal distress or uterine hyperstimulation appears, oxytocin is stopped. In an extreme case of improved The uterus stimulation and fetal distress, re-infusion with previous dose begins and continues with the same sequence. If 6 hours after induction does not change, the patient with pain induction is regarded as a failure of Bishop Score and Induction will be stopped But if you switch off the induction of cervical, induction continues. The rate of cervical dilatation and effacement during the induction phase of active labor and every 30 minutes every 15 minutes during the second stage of labor is controlled To determine the progress of labor.
Category
Treatment - Drugs
2
Description
The group 2 (oxytocip), First 10 units oxytocin spilled in 1000 cc of blood Ringer (2/5mu/min) Then four drops per minute infusion rate 2 / 5 is increased to the maximum mu / min 40 in.
The same amount will continue. After a good start uterine contractions, vaginal examination will be done if the patient Prom every hour and in rupture of the amniotic soc every 2 hour and every half hour inuterine contractions. mother's vital signs will be controlled before oxytocin induction and then each hour. If signs of fetal distress or uterine hyperstimulation appears, oxytocin is stopped. In an extreme case of improved The uterus stimulation and fetal distress, re-infusion with previous dose begins and continues with the same sequence. If 6 hours after induction does not change, the patient with pain induction is regarded as a failure of Bishop Score and Induction will be stopped But if you switch off the induction of cervical, induction continues. The rate of cervical dilatation and effacement during the induction phase of active labor and every 30 minutes every 15 minutes during the second stage of labor is controlled To determine the progress of labor.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labor unit of Vali-e-Asr Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Caspian Pharmaceutical Company
Full name of responsible person
Dr. Arghavani
Street address
No. 1, Fatemi Ave., Bisutun First Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Caspian Pharmaceutical Company
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vali-E-Asr Reproductive Health Research Center
Full name of responsible person
Rashidi Batool
Position
Associate Proffesor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Vali-Asr Hospital, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6658 1616
Fax
Email
bhrashidi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Haghollahi Fedyeh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)