Protocol summary

Summary
1-Objectives: To compare the effect of misopristol and oxytocin in the preparation of the cervix in the induction of labour 2-Design: Randomized, clinical trial, not blinded. 3-How to do: After explaining about labour induction procedures and prepare a written testimonial cervical consciously from the patient and his wife will be getting. Women who enter the entry criteria to fill will be plan . The embryos before the induction of childbirth rate is measured and recorded. Referring to random women in the 95-members will receive oxytocin or misopristol soon as a person to the extent of the contraction phase, optimal heart rate achieved the embryo will be evaluated. In cases of tachysystole (contraction or more over the course of 10 minutes) and hipertone/hypersystole of the uterus (uterine contraction with a duration of over 2 minutes) and in the absence of fetal heart rate changes, the usual way to treat these issues will. In the case of hiperstimulation syndrome or fetal hypoxia, disconnected and induction will be performing a cesarean section. 4- Participants : Entry criteria : Medical indication for the induction of delivery; Single twin pregnancies; Gestational age more than 36 weeks; Vertex presentation ;The normal heart rate of embryos .The exit criteria: The embryo-pelvic dystocia; An estimated weight of over 4000 grams or evidence of a lack of fitness cephalopelvic ; Abnormal vaginal bleeding or any placenta previa; The number of pregnancy over 4; Fetal malformation; Previous uterine scar; Any situation that does not cause vaginal delivery indication, Any contraindication use of misopristol ; Severe polyhydramnios . 5- Interventions: For women who receive misopristol, 50 mcg of medication in posterior vaginal fornix will be placed. The dose every 4 hours to 25 mcg can be repeated up to a pattern of at least 3 contraction in 10 minutes get. The maximum dose of 200 mcg. If this is the contractile pattern up to 4 hours after injection of the seventh dose drug is created, it will be deemed a failure of induction of labour. After acquiring the contractile pattern will not be prescribing other ideal misopristol. For women, group 2 mU/min drug oxytocin for intravenous infusion will be used in intervals of 30 minutes 2 times the amount of the drug, as long as proper contractile pattern. The dose up to maximum 20 mU/min infusion is increased and the limit will be preserved. If desired the contractile pattern up to 15 mU did, failure of induction of delivery will be considered. Even after the acquisition of optimum pattern of contractile administered oxytocin will continue. 6-The main outcome variables: Bishop Index

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012103011324N1
Registration date: 2013-01-13, 1391/10/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-01-13, 1391/10/24
Registrant information
Name
Mehrnoosh Namazi
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 8915
Email address
mohamadjafari-r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapur University of Medical Science, Vice Chancellor for Research and Technology
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between misoprostol and oxytocine in cervical ripening for labour induction: a randomized clinical trial
Public title
Comparison between misoprostol and oxytocine in cervical ripening for labour induction: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Entry criteria : Medical indication for the induction of delivery; Single twin pregnancies; Gestational age more than 36 weeks; Vertex presentation ;The normal heart rate of embryos .The exit criteria: The embryo-pelvic dystocia; An estimated weight of over 4000 grams or evidence of a lack of fitness cephalopelvic ; Abnormal vaginal bleeding or any placenta previa; The number of pregnancy over 4; Fetal malformation; Previous uterine scar; Any situation that does not cause vaginal delivery indication, Any contraindication use of misopristol ; Severe polyhydramnios
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 190
Randomization (investigator's opinion)
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
Ahwaz Ethic Committee of Jundishapur University of Medical Sciences
Street address
Ahwaz Jundishapur University of Medical Sciences , Esfand avenue , Golestan bulvard
City
Ahwaz
Postal code
61357-15794
Approval date
2012-06-09, 1391/03/20
Ethics committee reference number
493

Health conditions studied

1

Description of health condition studied
Failed medical induction of labour
ICD-10 code
O61.0
ICD-10 code description
Failed induction (of labour) by:•oxytocin•prostaglandins

Primary outcomes

1

Description
Bishop index
Timepoint
Baseline and every 30 minutes during the intervention and at the end of the intervention
Method of measurement
The questionnaire

Secondary outcomes

1

Description
Infantile complication
Timepoint
Baseline and every 30 minutes during the intervention and at the end of the intervention
Method of measurement
Apgar score

Intervention groups

1

Description
For women who receive misopristol, 50 mcg of medication in posterior fornix of vagina will be placed. The dose every 4 hours to 25 mcg can be repeated up to a pattern of at least 3 contraction in 10 minutes get. The maximum dose of 200 mcg. If this is the contractile pattern up to 4 hours after injection of the seventh dose drug is created, it will be deemed a failure of induction of labour. After acquiring the contractile pattern will not be prescribing other ideal misopristol
Category
Treatment - Drugs

2

Description
For oxytocin group 2 mU/min of the drug for intravenous infusion will be used in intervals of 30 minutes 2 times the amount of the drug, as long as proper contractile pattern. The dose up to maximum 20 mU/min infusion is increased and the limit will be preserved. If desired the contractile pattern up to 15 mU did, failure of induction of delivery will be considered. Even after the acquisition of optimum pattern of contractile administered oxytocin will continue. As soon as a person to the extent of the contraction phase, optimal heart rate achieved the embryo will be evaluated. Amniotomy will be conducted when the Bishop score over 7 and Bishop cervix over 6 cm. In cases of tachysystole (contraction or more over the course of 10 minutes) and hiprtone/hypersystole of the uterus (uterine contraction with a duration of over 2 minutes) and in the absence of fetal heart rate changes, the usual way to treat these issues will. In the case of hiprerstimulation syndrome or fetal hypoxia, disconnected and induction will be performing a cesarean section
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Razie Mohamadjafari MD
Street address
Imam Khomeini Hospital , Azadegan avenue
City
Ahwaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahwaz Jundishapur University of Medical Science, Vice Chancellor for Research and Technology
Full name of responsible person
Dr.Mostafa Feghhi
Street address
Vice Chancellor for Research and Technology , Ahwaz Jundishapur University of Medical Science, Esfand avenue , Golestan bulvard
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundishapur University of Medical Science, Vice Chancellor for Research and Technology
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
Ahwaz Jndishapur University of Medical Sciences
Full name of responsible person
Mehrnooh Namazi
Position
Assistant of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Sciences , Esfand avenue , Golestan bulvard
City
Ahwaz
Postal code
61357-15794
Phone
+91 63006324
Fax
Email
mohamadjafari-r@ajums.ac.ir ; alinazeri_76@yahoo.com ; mnamazi1979@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Science
Full name of responsible person
Razie Mohamadjafari
Position
Assistant Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Science , Esfand avenue , Golestan bulvard
City
Ahwaz
Postal code
61357-15794
Phone
+98 61 1222 2114
Fax
Email
alinazeri_76@yahoo.com; mnamazi1979@yahoo.com; mohamadjafari-r@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Science
Full name of responsible person
Mehrnoosh Namazi
Position
Assistant of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Science , Esfand avenue , Golestan bulvard
City
Ahwaz
Postal code
61357-15794
Phone
+98 61 1222 2114
Fax
Email
alinazeri-76@yahoo.com; mnamazi1979@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...